EP4100910A1

EP4100910A1 - Apparatuses, systems, and methods for diet management and adherence

Info

Publication number: EP4100910A1
Application number: EP21750986.8A
Authority: EP
Inventors: Anthony MARTORELL; Allison HIRSCH
Original assignee: Click Therapeutics Inc
Current assignee: Click Therapeutics Inc
Priority date: 2020-02-03
Filing date: 2021-02-03
Publication date: 2022-12-14
Also published as: CA3171296A1; WO2021158712A1; AU2021215868A1

Abstract

A computer implemented method for increasing diet management and adherence is provided. The method includes selecting a user position, an unfavorable position, and an unfavorable period of time; determining whether the user position and the unfavorable position are equal during the unfavorable period of time; and presenting, via the electronic device, an alert to the user if the user position and the unfavorable position are equal during the unfavorable period of time.

Description

APPARATUSES, SYSTEMS, AND METHODS FOR DIET MANAGEMENT

AND ADHERENCE

PRIORITY

[1] The present application claims priority to U.S. Provisional Patent Application No. 62/969,208, which was filed in the United States Patent and Trademark Office on February 3, 2020, the entire disclosure of which is incorporated herein by reference.

INTRODUCTION

[2] Embodiments of the invention relate generally to an apparatus for aiding user’s diet management and adherence via software engagement. Such software may include apphcations that may be running on an electronic device including a smartphone, tablet, or the hke.

[3] More than 1.9 billion adults worldwide are overweight, including over 650 million with clinically relevant obesity, and the number of obese patients continues to rise. According to the CDC, obesity is defined as a BMI of 30.0 or higher. Three classes of obesity exist: Class 1: BMI of 30 to <35; Class 2: BMI of 35 to <40; Class 3 (AKA extreme or severe obesity): BMI of 40 or higher. The medical rationale for weight loss in people with obesity is that obesity is a disease associated with a significant increase in mortality and many health risks, including type 2 diabetes mellitus, hypertension, dyslipidemia, and coronary heart disease. The higher the body mass index (BMI), the greater the risk of morbidity and mortality.

[4] The basis and cornerstone of treatment for obesity typically consists of a combination of behavioral and lifestyle modifications at any severity level. In more severe cases, the use of medical therapy and surgical therapy is utilized only to increase chances at creating critical behavioral and lifestyle modifications. With surgery and/or medication but no behavioral changes, patients may regress back to gaining weight. [5] A Digital Therapeutic (DTx) for Obesity can effectively digitize first line treatments such as behavioral therapies, lifestyle interventions to be used either standalone or in conjunction with medical therapy or surgical therapy.

[6] However, it may be particularly important that users are engaged, especially when use of such software is recommended and/or prescribed by a medical professional and/or other clinician for combating obesity.

[7] It would be desirable, therefore, to provide apparatuses, systems and methods for aiding individuals with obesity by providing digital therapeutics with a software application, in some instances, directed by their medical professional and/or clinician.

BRIEF DESCRIPTION OF THE DRAWINGS

[8] FIG. 1 illustrates a block diagram of a distributed computer system that can implement one or more aspects of an embodiment of the present invention;

[9] FIG. 2 illustrates a block diagram of an electronic device that can implement one or more aspects of an embodiment of the invention;

[10] FIGS. 3A-3H show source code that can implement one or more aspects of an embodiment of the present invention;

[11] FIG. 31 shows an output according to one or more aspects of an embodiment of the present invention; and

[12] FIGS. 4A-4H illustrate workflows that can implement one or more aspect of an embodiment of the present invention.

[13] While the invention is described with reference to the above drawings, the drawings are intended to be illustrative, and the invention contemplates other embodiments within the spirit of the invention.

DETAILED DESCRIPTION

[14] The present invention will now be described more fully hereinafter with reference to the accompanying drawings, which show, by way of illustration, specific embodiments by which the invention may be practiced. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Among other things, the present invention may be embodied as devices or methods. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware aspects. The following detailed description is, therefore, not to be taken in a limiting sense.

[15] Throughout the specification and claims, the following terms take the meanings explicitly associated herein, unless the context clearly dictates otherwise. The phrases “in one embodiment,” “in an embodiment,” and the like, as used herein, does not necessarily refer to the same embodiment, though it may. Furthermore, the phrase “in another embodiment” as used herein does not necessarily refer to a different embodiment, although it may. Thus, as described below, various embodiments of the invention may be readily combined, without departing from the scope or spirit of the invention.

[16] In addition, as used herein, the term “or” is an inclusive “or” operator, and is equivalent to the term “and/or,” unless the context clearly dictates otherwise. The term “based on” is not exclusive and allows for being based on additional factors not described, unless the context clearly dictates otherwise. In addition, throughout the specification, the meaning of “a,” “an,” and “the” includes plural references. The meaning of “in” includes “in” and “on.”

[17] It is noted that description herein is not intended as an extensive overview, and as such, concepts may be simplified in the interests of clarity and brevity.

[18] All documents mentioned in this application are hereby incorporated by reference in their entirety. Any process described in this application may be performed in any order and may omit any of the steps in the process. Processes may also be combined with other processes or steps of other processes. [19] FIG. 1 illustrates components of one embodiment of an environment in which the invention may be practiced. Not all of the components may be required to practice the invention, and variations in the arrangement and type of the components may be made without departing from the spirit or scope of the invention. As shown, the system 100 includes one or more Local Area Networks (“LANs”)/Wide Area Networks (“WANs”) 112, one or more wireless networks 110, one or more wired or wireless client devices 106, mobile or other wireless client devices 102-105, servers 107-109, and may include or communicate with one or more data stores or databases. Various of the client devices 102-106 may include, for example, desktop computers, laptop computers, set top boxes, tablets, cell phones, smart phones, smart speakers, wearable devices (such as the Apple Watch) and the like. Servers 107-109 can include, for example, one or more application servers, content servers, search servers, and the like. FIG. 1 also illustrates application hosting server 113.

[20] FIG. 2 illustrates a block diagram of an electronic device 200 that can implement one or more aspects of an apparatus, system and method for increasing diet management and adherence (the “Engine”) according to one embodiment of the invention. Instances of the electronic device 200 may include servers, e.g., servers 107-109, and client devices, e.g., client devices 102-106. In general, the electronic device 200 can include a processor/CPU 202, memory 230, a power supply 206, and input/output (I/O) components/devices 240, e.g., microphones, speakers, displays, touchscreens, keyboards, mice, keypads, microscopes, GPS components, cameras, heart rate sensors, light sensors, accelerometers, targeted biometric sensors, etc., which may be operable, for example, to provide graphical user interfaces or text user interfaces.

[21] A user may provide input via a touchscreen of an electronic device 200. A touchscreen may determine whether a user is providing input by, for example, determining whether the user is touching the touchscreen with a part of the user's body such as his or her fingers. The electronic device 200 can also include a communications bus 204 that connects the aforementioned elements of the electronic device 200. Network interfaces 214 can include a receiver and a transmitter (or transceiver), and one or more antennas for wireless communications .

[22] The processor 202 can include one or more of any type of processing device, e.g., a Central Processing Unit (CPU), and a Graphics Processing Unit (GPU). Also, for example, the processor can be central processing logic, or other logic, may include hardware, firmware, software, or combinations thereof, to perform one or more functions or actions, or to cause one or more functions or actions from one or more other components. Also, based on a desired application or need, central processing logic, or other logic, may include, for example, a software-controlled microprocessor, discrete logic, e.g., an Application Specific Integrated Circuit (ASIC), a programmable/programmed logic device, memory device containing instructions, etc., or combinatorial logic embodied in hardware. Furthermore, logic may also be fully embodied as software.

[23] The memory 230, which can include Random Access Memory (RAM) 212 and Read Only Memory (ROM) 232, can be enabled by one or more of any type of memory device, e.g., a primary (directly accessible by the CPU) or secondary (indirectly accessible by the CPU) storage device (e.g., flash memory, magnetic disk, optical disk, and the like). The RAM can include an operating system 221, data storage 224, which may include one or more databases, and programs and/or applications 222, which can include, for example, software aspects of the program 223. The ROM 232 can also include Basic Input/Output System (BIOS) 220 of the electronic device.

[24] Software aspects of the program 223 are intended to broadly include or represent all programming, applications, algorithms, models, software and other tools necessary to implement or facilitate methods and systems according to embodiments of the invention. The elements may exist on a single computer or be distributed among multiple computers, servers, devices or entities. [25] The power supply 206 contains one or more power components, and facilitates supply and management of power to the electronic device 200.

[26] The input/output components, including Input/Output (I/O) interfaces 240, can include, for example, any interfaces for facihtating communication between any components of the electronic device 200, components of external devices (e.g., components of other devices of the network or system 100), and end users. For example, such components can include a network card that may be an integration of a receiver, a transmitter, a transceiver, and one or more input/output interfaces. A network card, for example, can facilitate wired or wireless communication with other devices of a network. In cases of wireless communication, an antenna can facilitate such communication. Also, some of the input/output interfaces 240 and the bus 204 can facilitate communication between components of the electronic device 200, and in an example can ease processing performed by the processor 202.

[27] Where the electronic device 200 is a server, it can include a computing device that can be capable of sending or receiving signals, e.g., via a wired or wireless network, or may be capable of processing or storing signals, e.g., in memory as physical memory states. The server may be an application server that includes a configuration to provide one or more applications, e.g., aspects of the Engine, via a network to another device. Also, an application server may, for example, host a web site that can provide a user interface for administration of example aspects of the Engine.

[28] Any computing device capable of sending, receiving, and processing data over a wired and/or a wireless network may act as a server, such as in facilitating aspects of implementations of the Engine. Thus, devices acting as a server may include devices such as dedicated rack-mounted servers, desktop computers, laptop computers, set top boxes, integrated devices combining one or more of the preceding devices, and the like.

[29] Servers may vary widely in configuration and capabilities, but they generally include one or more central processing units, memory, mass data storage, a power supply, wired or wireless network interfaces, input/output interfaces, and an operating system such as Windows Server, Mac OS X, Unix, Linux, FreeBSD, and the like.

[30] A server may include, for example, a device that is configured, or includes a configuration, to provide data or content via one or more networks to another device, such as in facilitating aspects of an example apparatus, system and method of the Engine. One or more servers may, for example, be used in hosting a Web site, such as the web site www.microsoft.com. One or more servers may host a variety of sites, such as, for example, business sites, informational sites, social networking sites, educational sites, wikis, financial sites, government sites, personal sites, and the like.

[31] Servers may also, for example, provide a variety of services, such as Web services, third-party services, audio services, video services, email services, HTTP or HTTPS services, Instant Messaging (IM) services, Short Message Service (SMS) services, Multimedia Messaging Service (MMS) services, File Transfer Protocol (FTP) services, Voice Over IP (VOIP) services, calendaring services, phone services, and the like, all of which may work in conjunction with example aspects of an example systems and methods for the apparatus, system and method embodying the Engine. Content may include, for example, text, images, audio, video, and the like.

[32] In example aspects of the apparatus, system and method embodying the Engine, chent devices may include, for example, any computing device capable of sending and receiving data over a wired and/or a wireless network. Such client devices may include desktop computers as well as portable devices such as cellular telephones, smart phones, display pagers, Radio Frequency (RF) devices, Infrared (IR) devices, Personal Digital Assistants (PDAs), handheld computers, GPS-enabled devices tablet computers, sensor-equipped devices, laptop computers, set top boxes, wearable computers such as the Apple Watch and Fitbit, integrated devices combining one or more of the preceding devices, and the like. [33] Client devices such as client devices 102-106, as may be used in an example apparatus, system and method embodying the Engine, may range widely in terms of capabilities and features. For example, a cell phone, smart phone or tablet may have a numeric keypad and a few lines of monochrome Liquid- Crystal Display (LCD) display on which only text may be displayed. In another example, a Web- enabled chent device may have a physical or virtual keyboard, data storage (such as flash memory or SD cards), accelerometers, gyroscopes, respiration sensors, body movement sensors, proximity sensors, motion sensors, ambient light sensors, moisture sensors, temperature sensors, compass, barometer, fingerprint sensor, face identification sensor using the camera, pulse sensors, heart rate variability (HRV) sensors, beats per minute (BPM) heart rate sensors, microphones (sound sensors), speakers, GPS or other location-aware capability, and a 2D or 3D touch-sensitive color screen on which both text and graphics may be displayed. In some embodiments multiple chent devices may be used to collect a combination of data. For example, a smart phone may be used to collect movement data via an accelerometer and/or gyroscope and a smart watch (such as the Apple Watch) may be used to collect heart rate data. The multiple chent devices (such as a smart phone and a smart watch) may be communicatively coupled.

[34] Client devices, such as client devices 102-106, for example, as may be used in an example apparatus, system and method implementing the Engine, may run a variety of operating systems, including personal computer operating systems such as Windows, iOS or Linux, and mobile operating systems such as iOS, Android, Windows Mobile, and the like. Client devices may be used to run one or more applications that are configured to send or receive data from another computing device. Client applications may provide and receive textual content, multimedia information, and the hke. Chent applications may perform actions such as browsing webpages, using a web search engine, interacting with various apps stored on a smart phone, sending and receiving messages via email, SMS, or MMS, playing games (such as fantasy sports leagues), receiving advertising, watching locally stored or streamed video, or participating in social networks. [35] In example aspects of the apparatus, system and method implementing the Engine, one or more networks, such as networks 110 or 112, for example, may couple servers and chent devices with other computing devices, including through wireless network to client devices. A network may be enabled to employ any form of computer readable media for communicating information from one electronic device to another. The computer readable media may be non-transitory. A network may include the Internet in addition to Local Area Networks (LANs), Wide Area Networks (WANs), direct connections, such as through a Universal Serial Bus (USB) port, other forms of computer-readable media (computer-readable memories), or any combination thereof. On an interconnected set of LANs, including those based on differing architectures and protocols, a router acts as a link between LANs, enabling data to be sent from one to another.

[36] Communication links within LANs may include twisted wire pair or coaxial cable, while communication hnks between networks may utilize analog telephone lines, cable lines, optical lines, full or fractional dedicated digital hnes including Tl, T2, T3, and T4, Integrated Services Digital Networks (ISDNs), Digital Subscriber Lines (DSLs), wireless links including satelhte hnks, optic fiber links, or other communications hnks known to those skilled in the art. Furthermore, remote computers and other related electronic devices could be remotely connected to either LANs or WANs via a modem and a telephone link.

[37] A wireless network, such as wireless network 110, as in an example apparatus, system and method implementing the Engine, may couple devices with a network. A wireless network may employ stand-alone ad-hoc networks, mesh networks, Wireless LAN (WLAN) networks, cellular networks, and the like.

[38] A wireless network may further include an autonomous system of terminals, gateways, routers, or the like connected by wireless radio links, or the like. These connectors may be configured to move freely and randomly and organize themselves arbitrarily, such that the topology of wireless network may change rapidly. A wireless network may further employ a plurality of access technologies including 2nd (2G), 3rd (3G), 4th (4G) generation, Long Term Evolution (LTE) radio access for cellular systems, WLAN, Wireless Router (WR) mesh, and the like. Access technologies such as 2G, 2.5G, 3G, 4G, and future access networks may enable wide area coverage for client devices, such as chent devices with various degrees of mobility. For example, a wireless network may enable a radio connection through a radio network access technology such as Global System for Mobile communication (GSM), Universal Mobile Telecommunications System (UMTS), General Packet Radio Services (GPRS), Enhanced Data GSM Environment (EDGE), 3GPP Long Term Evolution (LTE), LTE Advanced, Wideband Code Division Multiple Access (WCDMA), Bluetooth, 802.11b/g/n, and the hke. A wireless network may include virtually any wireless communication mechanism by which information may travel between client devices and another computing device, network, and the like.

[39] Internet Protocol (IP) may be used for transmitting data communication packets over a network of participating digital communication networks, and may include protocols such as TCP/IP, UDP, DECnet, NetBEUI, IPX, Appletalk, and the like. Versions of the Internet Protocol include IPv4 and IPv6. The Internet includes local area networks (LANs), Wide Area Networks (WANs), wireless networks, and long-haul public networks that may allow packets to be communicated between the local area networks. The packets may be transmitted between nodes in the network to sites each of which has a unique local network address. A data communication packet may be sent through the Internet from a user site via an access node connected to the Internet. The packet may be forwarded through the network nodes to any target site connected to the network provided that the site address of the target site is included in a header of the packet. Each packet communicated over the Internet may be routed via a path determined by gateways and servers that switch the packet according to the target address and the availability of a network path to connect to the target site.

[40] The header of the packet may include, for example, the source port (16 bits), destination port (16 bits), sequence number (32 bits), acknowledgement number (32 bits), data offset (4 bits), reserved (6 bits), checksum (16 bits), urgent pointer (16 bits), options (variable number of bits in multiple of 8 bits in length), padding (may be composed of all zeros and includes a number of bits such that the header ends on a 32 bit boundary). The number of bits for each of the above may also be higher or lower.

[41] A “content delivery network” or “content distribution network” (CDN), as may be used in an example apparatus, system and method implementing the Engine, generally refers to a distributed computer system that comprises a collection of autonomous computers linked by a network or networks, together with the software, systems, protocols and techniques designed to facilitate various services, such as the storage, caching, or transmission of content, streaming media and applications on behalf of content providers. Such services may make use of ancillary technologies including, but not limited to, “cloud computing,” distributed storage, DNS request handling, provisioning, data monitoring and reporting, content targeting, personalization, and business intehigence. A CDN may also enable an entity to operate and/or manage a third party's web site infrastructure, in whole or in part, on the third party's behalf.

[42] A Peer-to-Peer (or P2P) computer network rehes primarily on the computing power and bandwidth of the participants in the network rather than concentrating it in a given set of dedicated servers. P2P networks are typically used for connecting nodes via largely ad hoc connections. A pure peer-to-peer network does not have a notion of clients or servers, but only equal peer nodes that simultaneously function as both “clients” and “servers” to the other nodes on the network.

[43] Embodiments of the present invention include apparatuses, systems, and methods implementing the Engine. Embodiments of the present invention may be implemented on one or more of client devices 102-106, which are communicatively coupled to servers including servers 107-109. Moreover, client devices 102-106 may be communicatively (wirelessly or wired) coupled to one another. In particular, software aspects of the Engine may be implemented in the program 223. The program 223 may be implemented on one or more client devices 102-106, one or more servers 107-109, and 113, or a combination of one or more client devices 102- 106, and one or more servers 107-109 and 113.

[44] Embodiments of the present invention, which may be implemented at least in part in the program 223, relate to apparatuses, systems and methods for diet management and adherence.

[45] Disclosed herein are apparatuses, systems and methods for treating obesity with a software application.

[46] Weight loss plans and general obesity treatments are most likely to provide beneficial results when taken as prescribed, and patient compliance/adherence to medical treatment as prescribed by a clinician is an established problem in both clinical trials and the real world.

[47] Another form of treatment in which patient comphance/adherence is important is one that consists of or includes interaction with an electronic device such as a smartphone, tablet, laptop, or the hke (i.e., Digital Therapeutics (DTx)). Such treatment may be complementary to or may replace a pharmaceutical treatment. For example, if a patient is heavily reliant on a particular fatty food, a clinician may prescribe a treatment of interacting with software running on an electronic device that monitors eating by the patient or otherwise interacts with the patient regarding eating.

[48] For example, the software may determine the location of the user by using location services (such as a GPS receiver and associated software) of the electronic device. If the software determines that the user is in a location where the user, and/or the population as a whole, and/or the user’s demographic, is more likely to eat, the software may take certain actions such as activating a camera, activating a microphone, activating sensors that can determine the presence of food, reminding the user not to eat by generating a message on the screen of the electronic device, asking the user if he or she is eating by generating a message on the screen of the digital device (including an answer prompt), calling the user with a prerecorded message, and the like.

[49] However, a person that has been prescribed such treatment may simply “click through” any prompts and would thus not provide positive results. Moreover, simply chcking through or not being actively engaged would not provide accurate results as to the treatment’s efficacy. For example, a user can easily chck through an activity answering “yes” or “done” to activities that were never actually completed by the user (prompts not actually read by the user, tasks not performed by the user, and the like).

[50] Embodiments of the present invention measure adherence of a given treatment by, for example, measuring the user’s physical activity. To bridge the gap between adherence and engagement, embodiments of the present invention include algorithms to personalize comphance remediation techniques based on user demographics and baseline user habits.

[51] More specifically, once a user is prescribed the treatment (i.e., interaction with a DTx, a software/app running on an electronic device such as a smartphone), the user may first input basic demographic information (e.g., age, weight, location, health history, and the like). During the first two (2) (or 1 or 3 or 4) weeks of treatment, baseline user habits are first recorded by the software. These inputs may then be used to monitor threshold limits throughout the treatment. If a threshold is missed (e.g., user’s physical activity time fails to meet the required time), the software will deploy in-app alerts and messages to encourage the user to be more engaged in physical activity.

[52] The in-app alerts and messages will be accessed from a library/database of messages, alerts, and educational information, stored either on the electronic device or on another device such as a server communicatively coupled with the electronic device. User response to the app (i.e., determining whether alerts were effective and whether the user is more or less engaged) is assessed by the software, and similar types of alerts will be used on an ongoing basis to promote user treatment engagement if the app determines that the thresholds have been passed. On the other hand, if the software determines that alerts were ineffective, different alerts will be selected from the library/database to determine whether other alerts may be more effective at changing user behavior.

[53] First, a DTx data platform is utilized in order to develop and train the predictive model. The platform collects data from its users including demographic information provided by users when a profile is first set up (for example, age, sex, and location of a user) and a user’s activity and interaction with the DTx. In the alternative, demographic information about a user may be obtained from other sources such as information obtained from publicly available databases, background checks, medical data, finding and crawling a user’s social media accounts, and the like. For example, in crawling a user’s social media accounts, certain proxies may be used to determine a user’s demographic information. For example, if a user uses particular words in their social media posts that are more likely to be used by a certain age demographic (e.g., millennials), it may be assumed such a user’s age is that of a millennial (e.g., an average millennial age may be assumed). Similarly, if a user “likes” or comments on a particular musical band, that a particular demographic (such as age) is more likely to listen to, it may be assumed that that user is part of that demographic. As another example, if a user likes or comments about a cause that is more likely to be supported by a particular demographic (such as a particular sex), it may be assumed that that user is part of that demographic.

[54] Once a user’s demographics are obtained and stored, time stamps of when a particular user first begins using a program aspect are collected and stored in a database (the database may be stored on the electronic device, such as a smartphone, or on a server communicatively coupled to the electronic device). Also, time stamps of when a particular user stops begins using a program aspect are collected and stored in a database.

[55] As noted above, DTx programs may include 2 types of program aspects that are relevant for treatment: (1) Missions, which are activities that mainly contain text, and some sections that require user interaction; and (2) Features, which are activities that mainly contain sections that require user interaction, and some text. Missions and Features can also differ on a Mission-to-Mission or Feature-to-Feature basis, depending on the treatment and the specific DTx. For example, some missions may range from including several sentences of information and no user interaction (e.g., a mission may include a user learning about their treatment and how a DTx can benefit them, with little to no user interaction) to being based only on receiving user input (e.g., a user selecting goals from a list and saving them). Some Features can range from requiring only one input from the user (i.e., user inputs their mood into the app (e.g., happy, sad, anxious, excited, and the like) to requiring a user’s attention and participation for a set period of time (e.g., asking the user to participate in a physical activity such as a 5-minute long breathing exercise).

[56] In an embodiment, the DTx program may be evaluated with a target population: adults with a primary diagnosis of obesity (body-mass index [BMI] >30 kg/m2); Age: 22-65 years old; Currently obese (body-mass index [BMI] >30 kg/m2); With a primary diagnosis of obesity.

[57] In an embodiment, the DTx program is configured with the initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention: a combination of diet, exercise, and behavioral modification. Many patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. The behavioral component may facilitate adherence to diet and exercise regimens. As a non-limiting example, this includes regular self-monitoring of food intake, physical activity, and body weight. In an embodiment, the goal of treatment for overweight/obese individuals is long-term weight reduction and improvement in overall health. In an embodiment, for patients who are unable to achieve weight loss goals with a comprehensive lifestyle intervention alone, options include pharmacologic therapy, the use of medical devices, or, in some cases, bariatric surgery. [58] In an embodiment, obesity treatment guidelines may include a treatment algorithm based on the 5 As framework (Assess, Advise, Agree, Assist, and Arrange). This may be an effective behavior-change counseling model. In an embodiment, each additional 5A step delivered by physicians may be associated with higher odds of patients increasing their motivation to lose weight, change their diet, and exercise regularly. Physicians who may use the 5As may show an increase in obesity management (i.e., diagnosis and coordinating follow-up) in primary care settings. In an embodiment, the DTx may identified several psychosocial factors and psychiatric and medical comorbidities associated with poor obesity treatment outcomes and supports the importance of a team-based approach to obesity care.

[59] In an embodiment, the “Assess” step may involve screening for obesity, comorbidities that are likely to interfere with weight loss, and the patient’s willingness to make health behavior changes. The Assess phase may include briefly assessing psychosocial characteristics and psychiatric and medical comorbidities associated with poor success rates in obesity treatment. In an embodiment, these comorbidities include binge eating, sleep disorders, depression, and chronic pain. A weight loss attempt without attention to these comorbid conditions may be at higher risk for failure, an experience that may increase the severity of the comorbid conditions and obesity. Weight loss outcomes may also differ by race/ethnicity, as a non-limiting example, among African Americans and Hispanic/Latinos. Weight gain prevention may need to be the short-term goal of intensive behavioral therapy for racial/ ethnic minority patients, and long-term behavioral therapy may be needed to achieve clinically significant weight loss among these high-risk populations.

[60] In an embodiment, the “Advise” step may involve counseling the patient about the health risks associated with their current weight status and the health benefits of modest weight loss (for example, 5%-10%). Patients may be interested in learning how their weight affects specific medical conditions, or their risk for medical conditions. Understanding the risks associated with obesity may influence the patient’s motivation to make health behavior changes. In an embodiment, patients should be encouraged to reduce their energy intake by 500-1000 calories per day via diet and exercise.

[61] In an embodiment, goal-setting may be a key health behavior change strategy. In an embodiment, appropriate behavioral goals may be Specific, Measurable, Attainable, Relevant, and Time-based (SMART). A non-limiting example of a SMART goal is, “I will walk for 30 minutes three times per week,” whereas “I will exercise more” is not a SMART goal. Patients may have unrealistic weight loss goals, which can increase the risk for feelings of failure and disappointment. In an embodiment, the “Agree” step involves a collaborative approach to setting realistic goals.

[62] In an embodiment, the “Assist” step may consist of identifying the barriers the patient is experiencing in achieving each of their behavioral goals and developing a plan with clear strategies to overcome these barriers (for example, problem solving). In an embodiment, an acronym representing the steps of problem solving is ADAPT, which stands for Attitude, Define the problem, generate Alternative solutions, Predict consequences, and Try out and evaluate the solution. In one embodiment, use of problem solving skills is associated with significant weight loss in treatment programs.

[63] In an embodiment, increasing accountabihty through regular (for example, monthly) follow-up is critical to maximizing success. In follow-up visits, physicians may assess the patient’s progress with SMART goals, review self-monitoring records, help the patient problem-solve any barriers encountered since the last visit, and review progress on referrals made. In an embodiment, the pace of weight loss varies across patients, with some losing 1-2 pounds weekly and others experiencing slower or negligible weight loss with frequent plateaus and occasional regains. Patients with slow or negligible weight loss in the first month may be referred for more intensive counseling with behavioral health or nutrition providers. [64] There may be a number of treatments for obesity including, but not limited it, dietary therapy, exercise, behavior modification, pharmacologies, devices, and bariatric surgery.

[65] In an embodiment, dietary therapy may refer to conventional diets that are defined as those with energy requirements above 800 keal/day. As non-limiting examples, these diets fall into the following groups: Balanced low-calorie diets and low-calorie versions of healthy diets (e.g., Mediterranean and Dietary Approaches to Stop Hypertension [DASH] diets); Low-fat diets; Low-carbohydrate and low glycemic index diets; High-protein diets; Very low calorie diets; and Alternate day fasting. Adults may lose weight when fed <1000 keal/day. Thus, even subjects who are concerned that they are "metabolically resistant" to weight loss may lose weight if they comply with a diet of 800 to 1200 keal/day. More severe caloric restriction may be expected to induce weight loss more quickly, in some instances, due to slowing of resting metabohe rate. In many embodiments, continued surveillance by both clinician and patient are beneficial for treatment success. Return visits with the clinician, dietician, or behaviorist may be scheduled at regular intervals to assess barriers, discuss next steps, and offer encouragement. In an embodiment, if weight loss is less than 5 percent in the first six months, something else should be tried.

[66] In an embodiment, exercise may be less potent than dietary restriction in promoting weight loss, increasing energy expenditure through physical activity is a strong predictor of weight loss maintenance. In an embodiment, physical activity may be performed for approximately 30 minutes or more, five to seven days a week, to prevent weight gain and to improve cardiovascular health. In one embodiment, there may be a dose effect for physical activity and weight loss, and much greater amounts of exercise are necessary to produce significant weight loss in the absence of a calorically restricted diet. When weight loss is the desired goal, a diet may be combined with physical activity and the activity may be gradually increased over time as tolerated by the patient. In an embodiment, a multicomponent program that includes aerobic and resistance training is preferred. Existing medical conditions, age, and preferences for types of exercise may all be considered in the decisions. Exercise may be important in maintaining weight loss. In an embodiment, involving aerobic exercise for short durations, diet, or a combination of both in moderately overweight subjects, those committed to diet-and-exercise may maintain more weight loss that a diet-only group.

[67] In an embodiment, behavior modification may be an essential component of a weight-losing strategy, whether used alone or in combination with pharmacotherapy or bariatric surgery. Diet change alone may produce a weight loss of 5 to 10 percent below baseline weight, with comprehensive lifestyle modifications (combination of diet change, exercise, and behavioral interventions) in instances resulting in even greater weight loss. In an embodiment, behavior modification or behavior therapy may be considered to be an essential component of managing the patient with overweight or obesity. The goals may be to help patients make long term changes in their eating behavior by, as non-limiting examples, modifying and monitoring their food intake; Modifying their physical activity; Controlling cues and stimuli in the environment that trigger eating. In one embodiment, a principal determinant of weight loss appears to be the degree of adherence to the chosen program. In another embodiment, patient preference is an important consideration when recommending any behavioral weight loss program.

[68] In an embodiment, there may be two basic assumptions underlying behavioral therapy for overweight patients: the first is that individuals with obesity have learned maladaptive patterns of eating and exercise that are contributing to weight gain and/or maintenance of their overweight state; and the second is that these behaviors can be modified and that weight loss will result. With this theory, principles of learning from schools of classical and operant conditioning are applied in training new behaviors. In several embodiments, behavioral treatment for the patient who is overweight seeks to, as non-limiting examples, alter the environment; alter environmental reinforcement contingencies; shape eating behavior and physical activity; provide health benefits by reducing the risk for developing diseases associated with obesity.

[69] In an embodiment, comprehensive lifestyle interventions may provide a structured behavioral program that includes a number of components. These components, as non-limiting examples, may be: setting initial goals; self-monitoring (keeping food diaries and activity records); controlling or modifying the stimuli that activate eating; eating style (slowing down the eating process); behavioral contracting and reinforcement; nutrition education and meal planning; increasing physical activity; social support; cognitive restructuring; and problem-solving. These same behaviors may be recommended to maintain lost weight, with the addition of frequent (i.e., weekly or more often) monitoring of body weight.

[70] In an embodiment, pharmacologies reduce and maintain weight loss in short term (6 to 12 months). Upon initiation of anti-obesity medication, clinicians may communicate several important messages to patients, as non-limiting examples: not every drug works for every patient; individual responses vary widely; when the maximal therapeutic effect is achieved, a plateau is reached and weight loss ceases; and when drug therapy is discontinued, weight gain can be expected. Achieving and maintaining weight loss may be made difficult by many factors, including weight loss-induced changes in energy expenditure and hormonal mediators of appetite, which favor weight regain. Therefore, anti-obesity medications may be favored longer term for weight loss maintenance if the medications are well-tolerated and individuals have achieved a greater than five percent weight loss while on them.

[71] In an embodiment where pharmacologies are present, improvement in one's health may be the goal, success may be measured by the degree of weight loss and measurable or perceived improvement in physical function, comorbidities, and/or sense of well-being. In one embodiment, weight loss should exceed 2 kg during the first month of drug therapy (1 pound per week), fall more than 4 to 5 percent below baseline between three to six months, and remain at this level to be considered effective. In one embodiment, a weight loss of 5 to 10 percent may substantially reduce the development of diabetes in those with prediabetes and reduce blood pressure and risk factors for cardiovascular disease in patients with cardiovascular risk factors.

[72] In an embodiment where pharamcologics are present, the benefits of weight loss must be considered in light of the potential risks of drug therapy. In an embodiment, in patients wishing to use anti-obesity medication for longer than four years, the lack of longer-term safety (and efficacy) data should be made known.

[73] In an embodiment, devices may be used in conjunction with weight loss.

There are several types of devices approved for use in the treatment of obesity. The use of one of these devices may be considered for use in those patients in whom medications are ineffective or not tolerated, for those patients who are unable or unwilling to undergo bariatric surgery, or as a bridging therapy prior to bariatric surgery. In an embodiment, when a clinician refers a patient to receive one of these devices, it is important to note that the BMI indication for each device is different, with a BMI range between 25 to 55 kg/m2. In addition, the majority of insurance companies in the United States do not cover the costs of these devices; the financial burden to the patient may be significant depending upon which device is used.

[74] In an embodiment, Laparoscopic adjustable gastric banding (LAGB) utilizes a surgically placed band around the top portion of the stomach, leaving only a small portion available for food and a narrow opening to enter the rest of the gut. The system may help the patient eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested. Such a device may be recommended weight loss in severe obesity in those who have been obese for at least five years and for whom nonsurgical weight loss methods have not been successful. In such a non-limiting example, they must be wilhng to make major changes in their eating habits and hfestyle. In one embodiment, patients must have a BMI of >40 kg/m2, BMI >35 kg/m2 with one or more weight-related complications, or be at least 100 pounds over their estimated ideal weight.

[75] In an embodiment, electrical stimulation (vagal blockade) systems may dehver small electrical pulses to block transmission of nerve signals in the vagus nerve. The vagus nerve is involved in regulating stomach emptying and signahng to the brain that the stomach feels empty or full. Vagal blockade may promote weight loss by suppressing neural communication between the brain and the stomach. As non-hmiting examples, such devices may be recommended for individuals who are at least 18 years old, with a BMI of 40-45 kg/m2, or BMI of 35-39.9 kg/m2 with one or more weight-related complications, and who have been unsuccessful with weight loss attempts by diet and exercise in a supervised program within the last five years.

[76] In an embodiment, intragastic balloon systems may be saline filled balloons placed in the stomach to take up space and produce a sensation of satiety. Such a device, as a non-hmiting example, may be recommended for weight reduction in conjunction with diet and exercise in adult patients with a BMI of 30 to 40 kg/m2 and one or more obesity-related comorbid conditions, or for adult patients with obesity who have failed weight reduction with diet and exercise alone.

[77] In an embodiment, gastric emptying (aspiration) systems may be a surgically placed gastrostomy tube used to drain a portion of the stomach contents after every meal, decreasing the calories absorbed. Such a device may be recommended for, as a non-hmiting example, patients aged 22 and older with a BMI of 35 to 55 kg/m2, and who have failed to achieve and maintain weight loss through non-surgical weight- loss therapy.

[78] In an embodiment, hydrogels may be orally administered products, taken twice daily before meals, which expand in the stomach and intestines to create a sensation of satiety. They may not be systemically absorbed, and are eliminated through the feces. Such a device may be recommended, as a non-limiting example, for use as weight management aids for adults with a BMI of 25 to 40 kg/m2 and are to be used in conjunction with diet and exercise.

[79] In an embodiment, candidates for bariatric surgery may include adults with a BMI >40 kg/m2, or a BMI of 35 to 39.9 kg/m2 with at least one serious comorbidity, who have not met weight loss goals with diet, exercise, and drug therapy. Bariatric surgery is one of the fastest-growing operative procedures performed worldwide. While bariatric surgery may cause a physical decrease in appetite/stomach potential, failure to adhere to a healthy lifestyle may cause recidivism

[80] As non-limiting examples, the following would benefit from a DTx option: An interest in a synergistic treatment effect from the combination of pharmacologic and behavioral therapies; preference for nonpharmacologic interventions; poor tolerance of pharmacologic treatment; medical contraindications for pharmacologic treatments; inadequate response to pharmacologic treatment; pregnancy, planned pregnancy, or nursing; history of excessive use of analgesic or other acute medications; hfe stress, deficient coping skills, or a comorbid psychological disorder that aggravates headache problems or disability; those who suffer from severe migraine may benefit from behavioral therapies adjunctive to pharmacologic treatment; Cognitive Behavioral Therapy (CBT) may reduce rates of anxiety and depression and progressive muscle relaxation may reduce muscle tension which may add to the experience of pain. As a further non-hmiting example, even with pharmacologies and/or surgery, lifestyle, dietary, and behavioral therapy are necessary treatments for every stage of obesity in order to prevent recidivism. However, the multiple aspects of non-pharmacologic treatment may make it difficult to adhere to, whereas a DTx has the opportunity combine multiple areas of treatment through Mechanisms of Action (MO As) and increase adherence and thereby improving outcomes. Many patients may find a lack of working alhance with health care professionals (HCP), not believing the HCP could adequately help with weight loss options. A DTx may help create a stronger working alliance to boost patients' own self efficacy in their weight loss journey. As non-limiting example, many people with obesity do not feel comfortable talking with their HCP about weight management, while many others may not see their weight as an issue or may be embarrassed.

[81] In an embodiment, the invention of the present disclosure utilizes combination therapy (where ‘combination therapy’ is (1) diet, (2) exercise, and (3) behavioral intervention). In an embodiment, a structured lifestyle intervention program is designed for weight loss (lifestyle therapy) consisting of a healthy meal plan, physical activity, and behavioral interventions should be made available to patients who are being treated for overweight or obesity. In an embodiment, lifestyle therapy is provided to patients with overweight or obesity including behavioral interventions that enhance adherence to prescriptions for a reduced- calorie meal plan and increased physical activity (behavioral interventions can include: self-monitoring of weight, food intake, and physical activity; clear and reasonable goal-setting; education pertaining to obesity, nutrition, and physical activity; face-to-face and group meetings; stimulus control; systematic approaches for problem solving; stress reduction; cognitive restructuring [i.e., cognitive behavioral therapy], motivational interviewing; behavioral contracting; psychological counseling; and mobilization of social support structures).

[82] In an embodiment, the invention of the present disclosure may recommend adults with obesity (BMI 30.0 or higher) to intensive, multicomponent behavioral interventions. Many behavioral interventions focused on problem solving may identify barriers, self-monitoring of weight, peer support, and relapse prevention. Interventions may provide tools to support weight loss or weight loss maintenance (e.g., pedometers, food scales, or exercise videos).

[83] Behavior-based weight loss interventions in adults with obesity may lead to clinically significant improvements in weight status and reduced incidence of type 2 diabetes. Many behavioral interventions may help participants achieve or maintain a 5% or greater weight loss. These interventions may consist of a combination of dietary changes and increased physical activity. A weight loss of 5% may be clinically important.

[84] Mindfulness training interventions may have a positive effect on weight loss, impulsive eating, binge eating, or physical activity participation in adults with overweight and obesity as measured by BMI, and self-report. Mindfulness training may significantly reduce impulsive eating from baseline to post-intervention in the intervention groups. Binge eating at post- intervention may be statistically lower in the intervention groups than in the control groups. Mindfulness training may significantly decrease binge eating from baseline to post-intervention in the intervention groups. Mindfulness-based interventions may have a positive effect on psychological and physical health outcomes in adults who are overweight or obese.

[85] Goal setting and self-monitoring may have a positive effect on establishing and maintaining healthy diet or physical activity. Goal setting and self-monitoring of behavior may predict the short-term and long-term effects of diet management. Feedback on outcome of behavior, as non-limiting examples, implementing graded tasks, and adding objects to the environment, using a step counter, may significantly aid in long-term diet management. Behavioral treatment strategies may improve adherence, with positive effects found for both session attendance (percentage) and physical activity (total min/week). Cognitive-behavioral therapy weight loss (CBTWL) may be an effective therapy for increasing cognitive restraint and reducing emotional eating.

[86] Continued surveillance by both clinician and patient are essential for treatment success. Return visits with the chnician, dietician, or behaviorist should be scheduled at regular intervals to assess barriers, discuss next steps, and offer encouragement. If weight loss is less than 5 percent in the first six months, something else should be tried.⁹

[87] In an embodiment, the DTx program may evaluate a number of MO As, including but not limited to: stimulus control, mindfulness and acceptance training, medication access and adherence, reaction techniques, personalized messaging, risk factors optimization (sleep, diet, physical activity), social engagement, diet optimization, physical activity, and a user reward system.

[88] The stimulus control MOA may be used to describe situations in which a behavior is triggered by the presence or absence of a specific stimulus. Behavioral treatment may involve the control of stimuh for the purpose of modulating dysfunctional behavior. The stimulus control MOA may remove or reduce environmental and social cues that trigger dysfunctional eating habits.

[89] The mindfulness and acceptance training MOA may be used for reducing anxiety and stress in high-arousal situations, and may help users cognitively process thoughts and emotions. In one embodiment, the mindfulness and acceptance training MOA includes mindfulness-based meditation. The mindfulness and acceptance training MOA help improve cognitive processing of dysfunctional thoughts and emotions to reduce food-related anxiety and arousal.

[90] The medication access adherence MOA may be used for tracking medication habits, doses, reminders, and prevention of overdose. The medication access adherence MOA may improve the likelihood of weight-loss success by ensuring medication is taken as prescribed.

[91] The relaxation techniques MOA may be used for guided breathing modulation and progressive muscle relaxation exercises, promoting a reduction in physical tension and psychological arousal. The relaxation techniques MOA may also evaluate a user during increased emotional arousal and guide them through a series of de-escalation modules. The relaxation techniques MOA may thwart an increase in emotional arousal, which is a risk for dysfunctional eating, thus reducing arousal through relaxation techniques helps reduce that risk.

[92] The personalized messaging MOA may be used for increasing positive usability experience, and making patients more likely to be adherent with the DTx regimen. The personahzed messaging MOA may contribute to an increase in mission completion, DTx interaction, and positive user experience.

[93] The risk factors optimization MOA may be used for patient personalization regarding trigger awareness/avoidance, predictions, and treatment specifications. This MOA may also track the user’s habits by evaluating food intake, behavioral events, and medication adherence, and formulating trends and predictions. Personalized weight -loss treatment plans may incorporate user risk factors for realistic weight-loss outcomes. The risk factors optimization MOA aid the user by evaluating food, behavior, and medication habits, which are critical for the user to understand trends, triggers, and prevent future food-related errors. [94] The social engagement MO A may be used to leverage a patient’s existing network of family, friends, and community to provide low-friction, accessible opportunities in-app for patients to form new connections and/or strengthen existing connections with those around them. Fostering social relationships may improve a patient’s quahty of life as well as outcomes. A social support network may be important for long-term weight-loss success. Thus, the social engagement MOA may increase a user’s motivation and reduce isolation.

[95] The diet optimization MOA may be used to personalized a diet plan for obesity treatment. In an embodiment, this MOA incorporates user baseline information to formulate a detailed diet plan consisting of calorie hmits, food restrictions, recommendations, and goals. This MOA may include a diet master, which synthesizes user food intake to their dietary plan, and schedules meals ahead of time. In an embodiment, the diet master enables all food items to be inputted, calories counted, and input errors to be accounted for. This MOA may also include nutrition guide, which provides user access to nutritional information of foods, meal preparation options, risk associated with foods in respect to their specific diet, and recommendations on buying fresh ingredients. The diet optimization MOA may lead to a reduction in calories and fat intake, which can help user’s lose weight.

[96] The physical activity MOA may include a personalized physical exercise plan for obesity treatment. In an embodiment, this MOA incorporates user baseline information to formulate a detailed physical exercise plan consisting of various exercise options, restrictions, recommendations, and goals. In a further embodiment, this MOA may synthesize user time spent moving and intensity to their physical exercise plan, and schedule fitness ideas of time. In one embodiment, all exercise events are inputted to this MOA, and input errors (for example, missed exercises) are accounted for. The physical activity MOA may increase energy expenditure through exercise increases calorie loss, allowing for increased weight- loss. [97] The user reward system MOA may incorporate completed goals and exercises and provides the user with abstract points for each accomplishment. In an embodiment, the more points the user accumulates, the higher the level they attain in the DTx.

[98] In an embodiment, each of the one or more MO As may have one or more missions associated with it.

[99] In an embodiment, the stimulus control MOA includes a mission (Control the Home Environment) where the goal mission is to help the user identity and change environmental and social cues that would encourage inappropriate eating behaviors. Non-limiting examples of stimulus control strategies include learning to shop carefully for healthy foods, keeping high-calorie foods out of the house, hmiting the times and places of eating, and consciously avoiding situations in which inappropriate eating occurs. In an embodiment, users may be recommended to check-in with this mission on a weekly basis in order to ensure best dietary practices. In one embodiment, during the check-in, they can check-off/note items that they are adhering to, and are still working on. For the purposes of one embodiment, the user should only eat while sitting down in the kitchen, and while not distracted by anything (for example, television, reading a book, talking on the phone, etc.). However, in an embodiment, some distractions are permissible (for example, speaking with another individual). In an embodiment, tempting food should be banned from the house, this means visitors should not be allowed to bring any food items that are prohibited; if they do, they must leave with them, or the user must throw/give them away. In one embodiment, users should also only be in the kitchen unless they are eating and/or preparing a meal, otherwise, stay-out. In an embodiment, the user may be prompted with personalized messages. As a non limiting example, one personalized message may be, “Did you throw/give away all of the extra large plates in the house? If not, would you like to set a reminder?”

[100] In an embodiment, the stimulus control MOA includes a mission (Control Meal Preparation) where the user should serve food at the kitchen counter, not the table. In an embodiment, when filling the plate with food, the user may be reminded remember to think in quantities of ounces (for example, 4 oz. of each food item is best). In one embodiment, the user may be encouraged to throw/give away larger than normal plates, incorporate smaller plates and glasses in pantry. Further, in an embodiment, the user may be prompted, when serving food, try to remove a little bit from each portion.

[101] In an embodiment, the stimulus control MO A includes a mission (Grocery Shopping Guidelines) embracing the idea to never shop when hungry or tired. Such a mission may inform the user, before shopping, to prepare a list of essential items only. Further, this MO A may teach the user to avoid tasting foods at the store, and always compare products to determine the healthiest choices available. In some embodiments, this mission may prompt the user to consult with the Nutrition Guide for further advice.

[102] In an embodiment, the stimulus control MO A includes a mission (Control How You Physically Eat) that may encourage the user to remember, it takes approximately 20 minutes for your stomach to send a message to your brain that it is full. Further, in a non-limiting example, the user may be prompted to prevent overeating, go slowly and that the ideal way to eat is to take a moderately sized bite, put your utensils down, take a sip of water, cut your next bite, take a bit, and so on. As another non-limiting example, the user may be prompted to not cut their food all at one time, and take their time to enjoy the food. In such a mission, the user may receive a personalized message: “Try taking small bites and drink plenty of water during dinner tonight!”

[103] In an embodiment, the stimulus control MOA includes a mission (Self- Control in Social Settings) instructing a user on what to do when arriving at a social event, it is permissible to eat a low-calorie snack that consists of fruits and vegetables only so that you do not arrive hungry. Further, the user may be prompted to not skip meals in the day to save room for the special event. In an embodiment, where the user does eat, the user may opt to choose small portions, and/or share the meal with someone. In another embodiment, the user should always limit alcoholic beverages to a minimum. It may help to let your friends and family know about the user’s restrictions in order to prevent peer-pressure (for example, additional amounts of foods, more alcohol, deserts, etc.).

[104] In an embodiment, the mindfulness and acceptance training MOA the goal is to help users focus their attention on the present, and accept feelings of emotional discomfort. This may be performed during situations of distress that are in addition to periods of emotional eating.

[105] In an embodiment, the mindfulness and acceptance training MOA includes a mission (Mindfulness of Breath) where the goal may be to enhance breathing modulation. As a non-limiting example, users can follow an audio script that will guide them during the practice (for example, “Start by setthng into a comfortable position and allow your eyes to close. You can open your eyes if you feel that you’re getting sleepy. Begin by taking several long slow deep breaths breathing in fully and exhaling fully. Breathe in through your nose and out through your nose or mouth. Allow your breath to find its own natural rhythm. Bring your full attention to noticing each in-breath as it enters your nostrils, travels down to your lungs and causes your belly to expand...”). In an embodiment, such a mission is accompanied by the personalized message: “Take a moment out of your day today to check-in with yourself and breathe. Would you like to set a reminder?”

[106] In an embodiment, the mindfulness and acceptance training MOA includes a mission (Five Senses) where the goal is to increase attention to the five senses. In an embodiment, users may follow an audio script that will guide them on noticing something they are experiencing with each sense (for example, “Look around you and bring your attention to something you don’t usually notice. Bring your attention to the details, colors, shape, and texture. Maintain your attention on the objects looking for further details.” After 3 minutes, switch to a different sense).

[107] In an embodiment, the mindfulness and acceptance training MOA includes a mission (Enhance My Awareness) where the mission aims at increasing users’ awareness of their own thoughts and helping them look at their thoughts in a non- judgmental way. In an embodiment, users may follow an audio script that will guide them in this exercise (for example, “To begin, sit or he down in a comfortable position and try to let all tension in your body dissipate. Focus on your breathing first, then move your awareness to what it feels like to be in your body, and finally move on to your thoughts. Be aware of what comes into your head, but resist the urge to label or judge these thoughts. Think of them as a passing cloud in the sky of your mind. If your mind wanders to chase a thought, acknowledge whatever it was that took your attention and gently guide your attention back to your thoughts.”).

[108] In an embodiment, the mindfulness and acceptance training MOA include a mission (Acceptance of My Thoughts and Feelings) where the mission focuses on fostering users’ acceptance of thoughts and feelings. In an embodiment, users may follow an audio track that will guide them during this exercise (i.e. “This practice will help you to calm and clear the mind as you become grounded to the present moment. Start by paying attention to your breathing, taking a few long breaths to get settled. Gently guide your attention to how you are feeling emotionally within yourself at this moment, note whatever feehngs arise within you whether they be positive, neutral or negative, whether they be strong or weak in intensity. They are all just emotions. All just feelings to be felt. etc.”). In such an embodiment, the user may be prompted with the following personahzed message: “Experiencing negative emotions and feelings can be disruptive to your day and eating habits, remember to check-in here when you need some help.”

[109] In an embodiment, the medication access and adherence MOA may have the goal of educating and tracking medication usage from the user. In an embodiment, medication education would consist of reminders to the user regarding its purpose and the effects it should have on the body. In such an embodiment, these reminders may be sent to the user throughout the weight-loss journey. In another embodiment, medication usage may also be tracked using this MOA, where the user would input whether the medication has been taken (for example, daily), any missed doses (for example, input errors), and any associated symptoms related to the medication. Further, in such an embodiment, this MOA may also provide warnings to the user when the medication has not been tracked/marked as taken, acting as a type of reminder. In one embodiment, this MOA may also provide information regarding appetite suppression in response to medication and calorie input; this can alert the user and appropriate clinician regarding efficacy of medication/DTx dose.

[110] In an embodiment, the medication access and adherence MOA includes a mission (Why am I taking medication?) where sometimes diet and exercise is not enough to lose weight. As a non-limiting example, the user may be reminded that specific forms of medications may help increase appetite suppression, giving the user an extra needed push for dietary adherence. Further, the user may be prompted that the particular medication works with their metabohsm to form the best weight -loss potential. In an embodiment, the user may be reminded that studies have also shown that users who take medication, along with restricted diet and exercise plan, tend to lose more weight for longer periods of time when compared to those who don’t take medication. In such an embodiment, the following personalized message may be presented to the user: “Did you know that your medication, along with your diet and exercise plan, has shown an average reduction of [x] lbs in a range of [x-x] months? Stick with it!”

[111] In an embodiment, the medication access and adherence MOA includes a mission (Medication Check-in) where goal is for the user to mark as complete every dose taken. In an embodiment, the user will also input missed doses here. In a further embodiment, the user will be informed and reminded about the importance of regular medication adherence through personalized messaging. As a non-hmiting examples, the user may be prompted with the following personalized messages: “Hi [User], I see that you haven’t taken your medication today? Would you hke to do so now?” and “It’s important to take your medication on time every day for the best efficacy! Would you like to set a reminder?” [112] In an embodiment, the medication access and adherence MOA includes a mission (My Appetite Suppression) where the goal is to track the user’s appetite suppression intensity (for example, 1-5 Likert scale) at various moments of the day, and correlate user information with calorie consumption. This MOA may help measure medication efficacy. In an embodiment, information regarding medication efficacy may be relayed to the user/clinician for potential dosage/DTx modification(s). As a non-limiting example, the user may be prompted with the following personalized message: “Hi [User], rate your current appetite right now in a scale of 1-5, where 1 is very little and 5 is a lot. (#)”

[113] In an embodiment, the relaxation technique MOA is configured to defuse and stabilize. Emotional eating may be considerable a problem in users with obesity. Emotional easting may refer to eating episodes that are associated with emotional triggers instead of physical hunger. Emotional eating may be associated with a higher frequency of snacking, eating in response to daily stressors, and greater consumption of energy-dense, high-fat foods. In an embodiment, the goal of this MOA is three-fold: (1) educate the user on what emotional eating is, (2) identify triggers that lead to emotional eating, and (3) defuse emotional arousal during episode.

[114] In an embodiment, the relaxation technique MOA includes a mission (What is Emotional Eating?) where the user may be informed that when we eat in response to an emotion instead of to the physical feeling of hunger, that is considered emotional eating. In an embodiment, most users find themselves looking for a sense of relief from these emotions whilst eating. This process may be an inappropriate coping strategy individuals use in order to find a temporary escape from their emotional state. This strategy may result in a vicious cycle that reinforces guilt, the same negative emotions, and continues overeating. In one embodiment, to break this cycle, the user must first understand the identifying of the emotional triggers and follow a series of steps to help de-escalate emotional arousal. [115] In an embodiment, the relaxation technique MO A includes a mission (Trigger Identification Journal) where a user experiences an increase in emotional arousal that causes them to crave food, or a non-emotional related sudden craving for food, they would be advised to open the trigger identification journal in the DTx. In an embodiment, the DTx would then proceed to ask the user what emotion they are feeling (if any), the emotional intensity (for example, 1-5 Likert scale), what kind of food they crave, the food craving intensity (for example, 1-5 Likert Scale); the DTx would also record the date and time of such emotional trigger for future prediction purposes. In an embodiment, following the input of information, the DTx would lead the user to the third step: de-escalation.

[116] In an embodiment, the relaxation technique MOA includes a mission (De- escalation) where there are two methods that the user can choose for de-escalation: manual and automatic. In one embodiment, manual de-escalation involves a list of strategies that are known to cognitively distract the user from their arousal status and craving. As non-limiting examples, such strategies are noted: Work on hobbies and handcrafts for 10 min, Go for a 10 min walk, Watch a movie, Clean the room, Text a friend, Listen to music/podcast, Read a book chapter, Play a video game, Water your plants or work in the garden, Take a warm shower or bath, Light stretching (10 min). In an embodiment, automatic de-escalation may involve breathing modulation and/or progressive muscle relaxation.

[117] In an embodiment, the personalized messaging MOA includes several missions, manifesting as personalized messages. As non-limiting examples, “[User], it looks like your job is serving breakfast tomorrow, uh oh! Make sure you eat before hand! Would you like to set a reminder?” “[User], this is a reminder that you have [X] amount of calories left for the day. Resist that sweet tooth!” “Good morning,

[user name]! Check-out the Nutrition Guide during lunch time today for some tasty options! Would you like to set a reminder?” “Having trouble getting fresh veggies? Check-in with the Nutrition Guide for some great grocery locations and money saving tips!” [118] In an embodiment, the risk factors optimization MOA includes a baseline profile where before any treatment plan specification, it is advised to first evaluate the user’s previous and current weight, body measurements, risk factors, range of mobility potential, and fundamental motivation (for example, to lose weight, as this motivation may change over time). In an embodiment, these factors provide valuable information regarding establishing overweight/obesity severity, as well as the appropriate methods for weight-loss and/or weight-maintenance. The one or missions may be an algorithm to establish an appropriate baseline.

[119] In an embodiment, the risk factors optimizations MOA includes a mission (Body Mass Assessment) where two measurements should be acquired from the user: body mass index (BMI) and waist circumference. In an embodiment, these measurements will establish baseline weight and body shape. In a further embodiment, users may not know waist circumference and may not have a tape measure available. In an embodiment, thus, available forms of electronic measurements may be used (for example, iPhone can measure the diameter of an object, thus the DTx would perform basic arithmetic: C=nd). In an embodiment, waist circumference is additionally a predictor of risk by assessing locations of fat content. In such an embodiment, out of proportion body fat in users with BMI’s in the range of 25-35 kg/m2 significantly increased the risk for type II diabetes, hypertension, and coronary vascular disease (CVD). Further, in such an embodiment, fat in the abdominal region is associated with greater risk than with fat from peripheral regions (thighs/glutes/arms, etc.). In an embodiment, high risk individuals may be men with waists over 40 inches and women with waists over 35 inches. In an embodiment, BMI requires user knowledge and input of weight (Ib/kg) and height (ft/m), and is automatically calculated. As non-limiting examples, obesity class I may refer to BMIs of 30-34.9, obesity class II may refer to BMIs of 35-39.9 and obesity class III (Extreme Obesity) may refer to BMIs greater or equal to 40.

[120] In an embodiment, the risk factors optimizations MOA includes a mission (Risk Assessment) to calculate relative disease risk based on BMI, waist circumference, and gender. In an embodiment, relative risk factors include type II diabetes, hypertension, and CVD. In one embodiment, the user may be prompted: “Your risk of X is high, if weight-loss therapy does not immediately commence”. In an embodiment, absolute risk determination requires medical history, and a physical examination. In another embodiment, although this MOA is not designed to replace clinician guided medical history examination, identification of users at extremely high risk should be considered to be excluded. In an embodiment, a form of absolute risk may be performed through a series of questions, as a non-limiting example, “Do you have any history of the following: Myocardial infarction, Angina pectoris, Coronary artery surgery, Coronary artery procedures, Peripheral arterial disease, Abdominal aortic aneurysm, Symptomatic carotid artery disease, Type II diabetes (unmanaged).” In an embodiment, cardiovascular disease risk should also be assessed, as it is an important consideration when designing weight-loss plan. In an embodiment, risk may be assessed by the following, “Do one or more of the following categories apply to you: Cigarette smoking, Hypertension, High cholesterol, Impaired fasting glucose, Family history of myocardial infarction before age 55, If you are a male over 45, or a female over 55 (and/or are postmenopausal).” In an embodiment, if three or more are chosen, the user is at very high risk, and treatment plan should be modified. In one embodiment, cigarette smoking is strongly advised to stop, regardless of potential weight-gain (5-25 lbs). In an embodiment, the user may do this before or after weight-loss.

[121] In an embodiment, the risk factors optimizations MOA includes a mission (Mobility Assessment) where the range of body motions possible may be determined before advising specific physical exercises. In an embodiment, exercises will be based on the physical capability of the individual. In one embodiment, assessment can be addressed via the following questions: Do you have a history of joint disease(s), Do you have arthritis or Rheumatoid arthritis, Do you have a history of osteosclerosis, Do you have diabetes-related disabilities (i.e. loss of vascularization to extremities), Do you have any physical handicap(s), Are you capable of walking unassisted, If not, are you capable of walking with a cane/walker/strolling device, If you are not capable of walking unassisted and/or with a walking device, when was the last time you walked unassisted, If you are capable of walking, please answer the following questions, Do you have difficulty walking, Can you walk less than ¼ of a mile without taking a break, Can you walk less than ¼ of a mile in one hour, Compare your walking to 5 years ago (insert 1-5 Likert scale here).

[122] In an embodiment, the risk factors optimizations MOA includes a mission (Motivation Assessment) where the desire to lose weight effectively through a systems-wide approach is a fundamental aspect for weight-loss success. In such an embodiment, it is advisable to gauge the user’s interest in adhering to the weight- loss guidelines. Low motivation rates may also be a risk for weight-loss failure. In an embodiment, differences in motivation may warrant differences in user interaction, such as increases in praises, reminders, appointments, etc. In one embodiment, motivation may be assessed through a series of Likert scale questions such as: How much do you beheve that weight -loss will occur, Do you think your eating habits can change, How confident are you that physical exercise can be incorporated in your daily life, Acceptance that weight-management will be life long. Etc.

[123] In an embodiment, the risks factors optimizations MOA includes a mission (Track my Food and Exercise Baseline) where the number of calories consumed as well as any previous regimen of physical exercise needs to be recorded during baseline before a weight-loss plan begins. In an embodiment, this will occur for 1- week through the ‘Track My Habits’ MOA; here, the user will input every piece of food and amount of physical exercise performed during the first week using the DTx. In one embodiment, this MOA will then calculate the details of calorie consumption, evaluating the user on food consumption based on differences between: weekdays/ends, types of food consumed, periods when food/types of food consumption is highest (for example, midnight snacking of cheese on weekdays), number of meals, percent distribution of nutritional value of calories (for example, 35% of calories are fats and oils), etc. In an embodiment, from these estimates, the DTx will determine the number of calories for the weight -loss plan. In a further embodiment, this MOA will incorporate this data and use it to remind/alert the user regarding potential risk-associated events/times regarding food along with tips on how to overcome risk (for example, reminder to the user regarding Tuesday evenings, 88% history of eating fast food around 7pm; try to have dinner at 6pm to curb appetite for fast food).

[124] In an embodiment, the risks factors optimizations MOA includes a mission (Track my Behavioral Associations Basehne) where behavioral associations with food consumption will also be tracked in this MOA, this is advisable as individuals with obesity may suffer from emotional eating (for example, positive and/or negative valences). In an embodiment, it is may be advisable to record when such situations occur, the events surrounding such occurrences, how often, what kind of food, and what feelings were occurring. Becoming cognizant of emotional behavior surrounding food may be a step toward identifying behavioral/environmental triggers and finding alternative methods to process such behavior.

[125] In an embodiment, the risks factors optimizations MOA includes a mission (Track my Progress) where Following the first week of baseline recording, this MOA will continue to track user-based food intake information, indefinitely. In an embodiment, this will provide the user with data throughout the DTx journey regarding food consumption trends, activity during risk-associated events, and critically important to weight -loss success: the abihty to view unrecognized behavior. In a further embodiment, the MOA may identify trends in calorie consumption, types of food consumed at specific days/hours, their nutritional value, appetite suppression, etc, and will alert the user.

[126] In an embodiment, the social engagement MOA includes, My Support Network, where the goal of this MOA is to provide access to members in the users support network. In one embodiment, this MOA would connect users to internal and external members in their network. In such an embodiment, internal members would consist of family, friends, and co-workers, and would primarily be used for encouragement and motivation purposes. Further, in such an embodiment, external members could be anonymous users in the DTx community that are available for support, specifically oriented toward advice, opinions, and troubleshooting problems. In another embodiment, questions that could be asked in the external members community could consist of phrases like: ‘How do you deal with...X?’, ‘Do you ever experience...X?’, and ‘Sometimes I think.... X’

[127] In an embodiment, the social engagement MO A includes a mission (Reach- out to a friend) where the goal of this mission is for the user to contact a friend and communicate with them about the journey so far/status regarding weight -loss. In an embodiment, the purpose of this call is for increased motivation and encouragement from loved ones. In a further embodiment, users would ideally be reminded to contact family/friends/coworkers in a semiweekly basis, or as they see fit. Such an embodiment may include the personalized message: “[User], would you like to check in with [close friend] tonight? Maybe you can talk about your recent exercise successes.”

[128] In an embodiment, the social engagement MOA includes a mission (Access the Weight-Loss Community) where the goal of this mission is for the user to contact individuals they may not necessarily know, and ask for advice, opinions, and/or dieting and physical exercise troubleshooting. In an embodiment, it may be important to recognize that family members may not fully understand the continuous struggle users with obesity face; speaking with members in the same community can provide a sense of communal effort. In an embodiment, users would ideally be reminded to contact community members in a semiweekly basis, or as they need fit. In such an embodiment, users may be presented with the following personalized message: “Do you have tips for having fun while stairwalking, or any other exercise? Chime-in the community!”

[129] In an embodiment, the diet optimization MOA includes a mission (Nutrition Guide) where a key element for the user to succeed in dieting is access to nutrition information. Many users have good intentions on eating well during dieting, however they may not have the experience and/or knowledge of what constitutes a well-balanced meal. In an embodiment, this MOA will provide an on-hand guide for users to identify the nutritious content of any food they consider, as well as how that food item matches with their dietary plan. In another embodiment, this guide may also provide tips and suggestions for meal preparations. In a further embodiment, access to diverse ingredients, such as fresh vegetables and fruits is essential; this guide should consider providing information on locations where to access such foods.

[130] In an embodiment, including the diet optimization MO A, a user may input a food. As a non-hmiting example, the user may input (1) glazed donut. In such an example, the DTx may output include: Nutrition Facts, Calories 240, Sodium 270 mg, Total Carbohydrate 33 g, Dietary Fiber 1 g, Sugars 13 g, DTx Recommendation: Strongly Advised Against, DTx Reasoning: Sonia, you have 550 calories left for today. That means 1 serving will consume 44% of your limit. This food also has a high glycemic index, which is contradictory toward your type II diabetes status. Since you want something sweet, can you have a piece of fruit (1 serving)? YES/NO. (If NO Try to eat half of the doughnut instead). In another non-limiting example, the user may input “I need help with dinner tomorrow.” In such a non-limiting example, the DTx may prompt the user with “cost range?,” enabling the user to input their cost range. Further, in such a non-hmiting example, the DTx may output: “the following food will be a great choice considering your calorie count for today, and cost limit. 1. Lean ground beef (4 oz) a 150 cal, 6g fat, etc, 2. Pan seared carrots (4 oz) a nutrition info here, etc, 3. Brown rice (4 oz) a nutrition info here, etc., DTx output: the closest location where these items can be bought is: Fairway Market 2328 12th Ave, New York, NY 10027 See Directions.” Such non limiting examples may be accompanied by personalized messages, for example: “Good morning, [user name] ! Check-out the Nutrition Guide during lunch time today for some tasty options! Would you like to set a reminder?” and/or “Having trouble getting fresh veggies? Check-in with the Nutrition Guide for some great grocery locations and money saving tips!”

[131] In an embodiment, including the diet optimization MO A, a “Diet Master” may help the user schedule meal planning ahead of time, with any ingredients chosen from the nutrition guide, if available. In an embodiment, access to this MOA will also provide the opportunity to continuously input calories throughout the day (calorie counting), input errors (for example, I ate half a doughnut in the morning, approx. 120 calories), and provide predictors regarding calorie surges related to stressors and/or the environment. In an embodiment, this MOA will also gauge the user on whether they would like to eat the specified meal because they are physically hungry, or if because they are experiencing an emotional trigger/arousal; if the latter, they will be referred/forwarded to ‘Defuse and Stabilize’, where they will be led through a process of arousal de-escalation.

[132] In an embodiment, the diet optimization MOA may include a mission (Input Daily Food Intake) where the user would access the DTx to input every food item consumed throughout the day. In an embodiment, the DTx would automatically count and record calories, nutritional information, dates, and times, etc. In an embodiment, performing this mission would be key to accurate calorie counts each day, and is a critical component to the weight-loss program. If the user is not inputting calories throughout the day, the DTx may remind the user to register calories as the day progresses in order to be as accurate as possible. As a non limiting example: “User food entries for: 28 January 2020: 8:45am: (1) orange 45 calories, etc; 8:51am: (1) cup of coffee (with sugar and cream) 130 calories; (2) eggs 156 calories; (1) piece of whole-wheat toast 70 calories; Morning calorie summary: 401; Percent of fat content: XX%; Percent of carbohydrate content: XX%; Calories left for lunch and dinner: 1905. Predictor warning: 11:30am meeting may contain foods with high glycemic index (noted from previous history). User input error: 11:35am: (1) croissant 231 calories, etc; DTx Advice/Message: increase in glycemic index food content, new calorie summary is: 1674. Don’t give up! You can still incorporate healthy ingredients in lunch and dinner.”

[133] In an embodiment, the diet optimization MOA may include a mission (Schedule next week’s meals) where the goal of this MOA is to assist the user in planning meals ahead of time; this prevents spontaneous eating out and consuming inappropriate foods. In an embodiment, the user will be provided fill in the blank options for each day of the week, where they can choose from a variety of proteins, vegetables, grains, and fruits. Assistance from the Nutrition Guide may help with incorporating them into meals and buying. In an embodiment performing this mission allows the user to see how many calories they expect to consume ahead of time as well. Such a mission may be accompanied with the following personalized message: “Hi [User], it’s Sunday, don’t forget to plan for this week’s meals! Would you like to do it now?”

[134] In an embodiment, the diet optimization MOA may include a mission (Input of Food-related Emotional Arousal) where the goal of this mission is for the user to register the time and location of where they experience any emotions that make them want to consume food. In an embodiment, they would additionally input the category of emotion, and intensity (1-5 Likert Scale). In such an embodiment, this is used to understand the types of triggers unique to the individual, when they occur, and where. As a non-limiting example: “7:49pm: memory of grandmother passing; craving for chocolate (3.5/5 intensity) -> User is referred to deep breathing modulation exercise in MOA #7.”

[135] In an embodiment, the physical activity MOA includes a mission (Let’s Move) where this MOA may help the user schedule weekly exercises in advance, predicted calories lost, and input errors (i.e. missed a scheduled day of exercise). In an embodiment, the potential calories ‘lost’ during exercise may not be deducted from the dietary plan, and used as an excuse for additional eating throughout the day. As a non-limiting example, if they ‘burned’ 150 calories from walking 30 minutes, the user should not ‘cheat’ by not adding they ate half a doughnut (~150 calories) earlier that day. In an embodiment, it is important to track all eating habits, calories consumed, and physical exercises performed in order to change one’s eating behavior.

[136] In an embodiment, the physical activity MOA includes a mission (Input of Today’s Fitness) where the goal of this mission is for the user to specify the type of physical activity performed, duration, intensity, and any emotional associations during the activity (i.e., in a Likert scale of 1-5, they rated stairwalking a 2.5). In an embodiment, completing each exercise will provide the user with the approximate calories lost as a positive reinforcer. In an embodiment, error inputs, such as missed exercises will be registered here. Such a mission may be accompanied with the following personalized message: “Hi [User], don’t forget to check-in after your work out this evening. Keep at it, you’re on the right track!”

[137] In an embodiment, the physical activity MOA includes a mission (Schedule Next Week’s Fitness Plan) where the user will be provided fill in the blank options for each day of the week, where they can choose from a variety of exercises at different intensities and durations. In an embodiment, the DTx can alert the user on previous times and intensities for certain exercises, and whether the user would like to challenge themselves by increasing either amount (safely). Such a mission may be accompanied with the following personalized message: “Hi [User], this week was a major success! Your exercise activity increased by 24%. Let's schedule next week’s fitness plan now.”

[138] In an embodiment, the “Individualize My Plan” MOA may be where an individual user weight-loss plans will differ based on baseline information. In some embodiments, such as in users with severe metabolic disorders, realistic weight-loss may not be an option and weight-maintenance should be the goal. In an embodiment, this MOA will consist of weight-loss or maintenance goals/plan for the user as well specific goals the user has for themselves. In another embodiment, clinical guidelines suggest specific weight-loss goals/plan for first 6-months, followed by further weight-loss and/or maintenance goals/plan after the first 6- months, if weight -loss goals are met.

[139] In an embodiment, a mission (Our Goals for You) is where the following goals have been designed for your specific weight-loss plan for the first 6-months. In an embodiment, the user will be reminded of the importance of accomplishing each goal in a weekly status. In one embodiment, in the event that the user ‘falls of track’ on completing a specific goal, but resumes progress in the right direction, the specific goal will be modified to reflect such changes in a reasonable manner. As a non-limiting example, the user did not lose any weight for 2 months due to dietary noncompliance. As a further example, thus the chances that they will reach a 10% body weight loss by 6-months may not be realistic, thus, the DTx will adjust the weight-loss goal to a more realistic weight-loss percentage (6-7%). As a non-limiting example: “The first 6-month goals are below: 10% reduction in body weight; Loss of 1-2 Lbs per/week; Physical exercise 30 min/day for 3x/week- at minimum (if possible); Medication adherence; Significant reduction in fat and carbohydrate content in diet; Any reduction in blood pressure, cholesterol levels, and/or blood glucose levels (for people with type II diabetes).

[140] In an embodiment, a mission (My Personalized Goal) is where the user would have the option to describe personal goals they wish to achieve in 6-months. Non limiting examples of personal goals can be: Increase personal self-esteem; Lose weight for my family; Feel healthier; Re-gain a sense of control; Be able to walk/run to ‘X’; Be able to do ‘X’ again like before. In an embodiment, personal goals will be periodically re-visited to assess the user’s belief in completing the goal.

[141] In an embodiment, a mission (My First 6-month Plan) may include a diet component, including, as a non-limiting example: Calorie Restriction: For individuals categorized as obese I: a reduction in 600 kcal/day is recommended; For individuals categorized as obese II/III: a reduction ranging from 600-1000 kcal/day is recommended; For the user, this would best be seen/performed through ‘calorie counting’, where the total average of calories per day would be assessed (through the third MOA, ‘Track My Habits’); the appropriate reduction in calories (from 600- 1000 kcal) would be apphed to that average; that new average would now be the calorie hmit for each day (for example, Daily average intake: 3000 kcal; obese II; reduction in 800 kcal; new user kcal intake is: 2200 kcal p/day). A further non limiting example may include: Low glycemic index: An overall reduction in carbohydrates is recommended, however if carbohydrates are eaten, ones with medium to low glycemic index are preferred; Glycemic index (GI) is the measure of how much a carbohydrate raises blood sugar levels; low GI do not raise blood sugar as much as high GI; Examples of food with low, medium, and high GI can/should be accessed in the Nutrition Guide MOA. Some examples are below: Low GI (<55): ie. Legumes, pasta, whole-wheat bread; Medium GI (56-69): ie. Brown rice, quick oats; High GI (> 70) : ie. White-bread, potato, melons, popcorn. A further non-limiting example may include: Plate Compartmentalization Meals should try to be equally divided into protein, grains, vegetables, and sometimes fruit; This will help ensure appropriate number of servings/day and appropriate amounts. A further non limiting example may include: Restrictions and Recommendations: Reduce fat content, in meats and oils; 3 meals per day is recommended; Do not skip breakfast; Do not lump meals together; Snacking is to be avoided Snacks are avenues for high GI content, and small increments of calories that add up throughout the day;

Reduce alcohol consumption; Alcoholic beverages are generally high in calories, and tend to be mixed with juices/mixes, another source of calories; Reduce consumption of high energy liquids; High energy hquids (HEP) are a major source of calories, they are consumed quickly and often; HELs are soda, juice, syrups, highly sugared coffee drinks (i.e. Frappuccino ), milkshakes, etc; Stick with water (seltzer is OK), tea, coffee (no sugar); Food is not to be consumed past 7pm, unless directed by a physician due to medical issues (diabetes); Metabolic processing of food greatly reduces at night; When choosing food, low energy content and high vitamin/mineral content foods are preferred (steel cut oatmeal, NOT cereal); Note: specific food information can/should be accessed in the Nutrition Guide MO A; ‘Cheat days’ are not advised; however, mistakes are forgiven and will occur (obviously); The relationship with food is not the same between a person with obesity and a person that temporarily gained weight; Obesity is an eating disorder and should be treated as a hfe-long effort.

[142] In an embodiment, a mission (My First 6-month Plan) may include a physical exercise component, where physical exercise is critical as it is required for increased energy expenditure, and reduction in cardiovascular risk. In such an embodiment, dieting without physical exercise may not be as successful as with it combined, and will be necessary for reaching the 10% body weight reduction goal. Further, in such an embodiment, dieting alone typically results in a 3-5% body weight loss over a 6- month period. In an embodiment, the user may be reminded that to avoid injury, starting simple and gradually intensifying physical activity is key. In an embodiment, the user should have the abihty to choose less vigorous exercises over more time, or more vigorous exercises over shorter times. In another embodiment, an important aspect of this plan is to schedule exercises ahead of time and document the time and intensity of each exercise. As a non-limiting example, this will be performed with the help of the 6th MO A ‘Let’s Move!’ In an embodiment, examples of different forms of exercises for different durations of time are presented to the user. As a non-limiting example, approximately 150 kcal is lost for 1 exercise session as described (i.e. stairwalking for 15 minutes results in approximately the same calorie loss as ‘dancing’ for 30 minutes). In a further non-limiting example, users may not be able to achieve any of these exercises at first; They are recommended to start slow for any time possible, for example stairwalking for 4 minutes if they cannot do 15 minutes, 3x a week; With time, a larger weekly volume of physical activity can be performed that would normally cause a greater weight loss (if diet is adhered to as well); Reducing sedentary time could be another approach to physical exercise if none of these activities are possible; Exercises should be performed in a safe place/environment for movement (i.e. park/gym/sidewalk), if not accessible, exercise inside the home is recommended as well; Adherence to physical activity can increase if enjoyable forms of exercise are performed and the user identifies them as recreational; Thus, it is important to also allow the user the freedom to choose how they want to move, as it may also be considered a form of exercise; i.e. gardening, walking a dog, going to a museum (2 hours walking/standing), ‘window shopping’ at the mall, walking to the grocery store and back. Additional non-limiting examples of standard exercises at various intensities include: volleyball, walking, table tennis, raking leaves, social dancing, lawn mowing, jogging, field hockey, and running. In an embodiment, the details of physical exercises may be tracking in the “Let’s move” MOA or another MO A.

[143] In an embodiment, the Point-Based Reward System MOA may include a mission (Point-Based Reward System) where the goal of this MOA is to reward positive behavior throughout the weight -loss journey. In an embodiment, verbal praise is not enough (although it should be provided). In on embodiment, in an effort to increase internal motivation, the user will be rewarded through the standard gamification process of points. Games may be addictive because users want to gain more points, which are abstract units of pleasure. Thus, in an embodiment, this MOA will award points based on positive behavior changes throughout time, with the potential to compare points with other users (this adds competition, which can be positive). As non-limiting examples: “Congratulations! You reached your goal of exercising 3x this week. (+65 points). Double your points NOW if you complete a 10-minute walk!” and “Weekly point summary: 421. You unlocked Bronze Status! Your rank: 510/2150.”

[144] In an embodiment, a clinical study for an Obesity DTx would most likely have a complementary study design as several potential MOAs for this DTx have been clinically validated and therefore carry little scientific risk. In an embodiment, literature on key features of a potential Obesity DTx have consistent, good-quality evidence backing their efficacy. Feasibihty of the Obesity DTx may be ranked as follow: 3 - High scientific confidence + attainable clinical trial population; 2 - Medium/high scientific confidence and/or elusive clinical trial population; 1 - Low scientific confidence and/or unattainable clinical trial population.

[145] FIGS. 3A-3H show source code that can implement one or more aspects of an embodiment of the present invention. In particular, the algorithms shown in FIGS. 3A-3H show a novel interface and system for managing a diet management and adherence system comprising a user’s phone and/or a ring configured to be worn by the user. FIG. 31 shows an output according to one or more aspects of an embodiment of the present invention.

[146] Various programming languages may be used to implement embodiments of the present invention including Ionic + Python + Angular. Ionic is an open source, cross-platform framework used to develop hybrid mobile applications. Ionic is a mobile app development framework based on the HTML5 programming language. [147] Various databases may be used in embodiments of the present invention including MongoDB, which is a cross-platform document-oriented database program. Classified as a NoSQL database program, MongoDB uses JSON-like documents with optional schemas.

[148] AWS + Elastic Beanstalk + Docker may also be used. AWS Elastic Beanstalk is an easy-to-use service for deploying and scaling web applications and services developed with Node.js and Docker on servers such as Apache, Nginx.

[149] Elastic Beanstalk automatically handles the deployment, from capacity provisioning, load balancing, auto-scaling to application health monitoring.

[150] The algorithms shown in FIGS. 3A-3I are as follows.

[151] The first algorithm includes a television detection algorithm, which may include the phone detecting when the user is listening to television by distinguishing between (1) real voices and sounds and (2) voices and sounds emanating from a speaker. In an embodiment, if the phone detects that a television is on, the ring vibrates, and a message on the phone instructs the user to perform exercises such as jumping jacks, push-ups, etc.

[152] The second algorithm includes an exercise detection algorithm. In such an embodiment, the ring is equipped with a tiny gyroscope. In such an embodiment, if the ring does not detect motion associated with exercise while the phone detects that the television is on, the ring will continue vibrating until the user performs exercises.

[153] The third algorithm includes a kitchen and designated eating area detection algorithm. In such an algorithm, signal devices in the form of adhesive metal beads may be positioned in the corners of the kitchen as well as the corners of a designated eating area. In such an embodiment, if the phone detects that the ring is in an area transcribed by the metal beads, (i.e., the kitchen) at a period of time not typically appropriate for a meal time, the phone will instruct the user to leave the kitchen. In such an embodiment, if the phone detects (a) the movement of the ring matches a pattern associated with bringing food to one’s mouth and (b) that the user is not in either the kitchen or the designated eating area, the phone will instruct the user to (1) eat in the kitchen if it is a meal time, or (2) to leave the food in the kitchen until it is meal time. In an embodiment, the ring will continue vibrating until the user stops eating outside the designated eating area and stops eating outside of a meal time.

[154] FIGS. 4A-4H show workflows that can implement one or more aspects of an embodiment of the present invention. In particular, FIG. 4A refers to receiving audio from a microphone or any sound recording device. Referring to FIG. 4A, the workflow begins 401 the program, the model is loaded 402 on the device, the class names are read 403, then, receiving audio from a microphone or any sound recording device is taken 404, ensuring a sample rate 405. Next, basic info 406 is taken from the audio and spectogram of audio is built 407, where classes may be matched 408. A message may then be sent to the user 409 and the instance of this workflow may end 410. FIG. 4B refers to finding the name of the class with the top score when mean-aggregated across frames. Referring to FIG. 4B, the workflow begins 411 and the names of the class with the top score when me an -aggregated across frames are found. The file may then be read with class names 412 and a dictionary made 413, returning the dictionary 414 (returning list of class names corresponding to score vector), allowing the workflow to end 415. FIG. 4C illustrates a method for enduring sample rate, resamphng a waveform, if required. Referring to FIG. 4C, the workflow begins 416, if the original sample rate is the desired sample rate 417, then the file is returned with the desired length and resampled waveform 420. If the original sample rate is not the desired sample rate 417 then the desired length is calculated 418 and waveform resampled 419. Next, the file is returned with the desired length and resampled waveform 420, enabling the workflow to end 421. FIG. 4D illustrates a method of returning hsts of sticky devices with the user’s position. Referring to FIG. 4D, the workflow begins 422 and a hst of sticky devices 423 is acquired, returning a list of devices 424, enabling the workflow to end 425. FIG. 4E refers to a method of getting a user’s position at a current moment. Referring to FIG. 4E, the workflow begins 426, gets user position at the current moment, returns object with user device info 427, and ends 428. FIG. 4F illustrates a method for matching a user wearable device position with sticky devices in a particular room. Referring to FIG. 4F, the workflow begins 429, gets user device data 430, and gets the sticky devices hst 431. For every key and device in the sticky devices list 432, if user device position is as close as possible to sticky devices 433, then a device location is set 434, returning a location 435, enabling the workflow to end 436. For every key and device in the sticky devices list 432, if user device position is not as close as possible to sticky devices 433, the workflow returns to every key and device in sticky devices list 432, then returns location 435, enabling the workflow to end 436. FIG. 4H illustrates a method where the current time is compared with the trigger time, returning false if the current time isn’t equal to the trigger time. Referring to FIG. 4H, the workflow begins 437, the current time is retrieved 438, and trigger time points are set 439. If the current time is equal to the trigger time 440, then true is returned 442, and the workflow ends. However, if the current time is not equal to the trigger time 440, then false is returned 441, enabling the workflow to end 443.

[155] While this invention has been described in conjunction with the embodiments outlined above, many alternatives, modifications and variations will be apparent to those skilled in the art upon reading the foregoing disclosure. Accordingly, the embodiments of the invention, as set forth above, are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention.

Claims

WHAT IS CLAIMED IS:

1. A computer system for increasing diet management and adherence on an electronic device comprising one or more processors, one or more computer-readable memories, and one or more computer-readable storage devices, and program instructions stored on at least one of the one or more storage devices for execution by at least one of the one or more processors via at least one of the one or more memories, the stored program instructions comprising: selecting a user position, an unfavorable position, and an unfavorable period of time; determining whether the user position and the unfavorable position are equal during the unfavorable period of time; and presenting, via the electronic device, an alert to the user if the user position and the unfavorable position are equal during the unfavorable period of time.

2. The mobile apphcation diet management and adherence system according to claim 1, wherein the user position correlates to a secondary electronic device.

3. The mobile apphcation diet management and adherence system according to claim 1, wherein the alert continues until the user position and the unfavorable position are no longer equivalent during the unfavorable period of time.

4. The mobile apphcation diet management and adherence system according to claim 1, wherein the secondary electronic device is equipped with a gyroscope.

5. The mobile apphcation diet management and adherence system according to claim 1, wherein the electronic device is equipped with a microphone.

6. The mobile apphcation user engagement system according to claim 5, wherein the electronic device presents a distraction alert if the microphone detects a distracting sound.

7. A computer implemented method for increasing diet management and adherence, the method comprising: selecting a user position, an unfavorable position, and an unfavorable period of time; determining whether the user position and the unfavorable position are equal during the unfavorable period of time; and presenting, via the electronic device, an alert to the user if the user position and the unfavorable position are equal during the unfavorable period of time.

8. The mobile application diet management and adherence method according to claim 7, wherein the user position correlates to a secondary electronic device.

9. The mobile application diet management and adherence method according to claim 7, wherein the alert continues until the user position and the unfavorable position are no longer equivalent during the unfavorable period of time.

10. The mobile application diet management and adherence method according to claim 8, wherein the secondary electronic device is equipped with a gyroscope.

11. The mobile application diet management and adherence method according to claim 7, wherein the electronic device is equipped with a microphone.

12. The mobile application user engagement method according to claim 11, wherein the electronic device presents a distraction alert if the microphone detects a distracting sound.