KR102606628B1 - Digital therapeutics and applications to treat overweight or obesity - Google Patents

Abstract

The present invention relates to a program or application stored on a computer-readable recording medium for treating overweight or obesity, a digital treatment device, and a method for managing overweight or obesity. The program and method for treating overweight or obesity provided by the present invention clinically achieves significant initial weight loss in the user by providing the user with a calorie-restricted alternative diet set according to the user's target weight or obesity level for a long period of time. and achieve long-term sustained weight loss and maintenance, and can be used in overweight or obesity treatment programs, digital treatment devices, and/or weight management or control methods.

Description

Digital therapeutic devices and applications to treat overweight or obesity}

The present invention relates to a digital treatment device for treating or managing overweight or obesity. More specifically, a computer program or application used to treat overweight or obesity using a calorie-restricted diet, and a digital treatment device based on the same. It relates to digital therapeutics (DTx) and methods for managing overweight or obesity.

Obesity refers to a condition in which abnormally excessive fat is accumulated in the body due to an energy imbalance in which energy intake exceeds energy consumption over a long period of time. Medically, obesity is recognized as a type of chronic disease. In addition, overweight is defined as the stage just before reaching obesity, i.e., the pre-obesity stage, in which body weight has increased beyond the standard or normal weight.

The World Health Organization (WHO) defines overweight as a body mass index (BMI) of 25 or more but less than 30, and obesity as more than 30. Obesity is classified into obesity (BMI 30 to 34.9) and severe obesity depending on the degree. It is broadly classified into three stages: (BMI 35 to 39.9) and very severe obesity (BMI 40 or more). It is known that people who are of normal weight but become overweight quickly become obese.

Based on the indicator of the percentage of overweight and obese population in member countries with available statistics, OECD calculated the overweight and obese population aged 15 or older to be 58.7% of the population on OECD average in 2020, which is a 3.3% increase from the OECD average of 55.4% in 2015. It's a shame. In Korea, 37.8% of the population aged 15 or older are overweight and obese, showing the second lowest proportion of overweight and obese people among OECD member countries, following Japan at 27.2%. However, the proportion of the overweight and obese population in Korea has increased by 4.4% over the past five years from 33.4% in 2015, showing a higher rate of increase in the obese population than the OECD average, and the obesity rate among men is on the rise significantly (Ministry of Health and Welfare, OECD Health Statistics, 2022).

In many studies, overweight or obesity is known to be highly associated with the development of diabetes, high blood pressure, hyperlipidemia, coronary artery disease, a wide range of cardiovascular diseases, and various cancers and joint diseases. In addition, even if there is no metabolic abnormality, obesity itself is associated with the development of dyslipidemia, hypertension, metabolic syndrome, osteoarthritis, breast cancer, uterine cancer, Cushing's syndrome, and depression. Accordingly, obesity is associated with morbidity, disability, Not only does it significantly increase the mortality rate, but it also significantly reduces the quality of life. Overweight or obesity causes significant social losses such as health insurance and medical expenses as well as personal health problems, so the need to prevent and treat overweight and obesity is steadily increasing.

Overweight or obesity requires continuous management because it is a condition that can continue to recur if it is not accompanied by consistent changes in lifestyle habits and management. The basis for treating overweight or obesity is still primarily diet control, exercise, and correction of behavioral habits that can be maintained for a lifetime, so research on overweight or obesity treatment is focused on deriving the most efficient weight loss method.

As a result of review and analysis of various research literature, weight loss through dietary substitution is recognized as one of the effective methods for treating overweight or obesity, and many consumers are using it, but there is not much evidence and research on it yet. . In addition, diets that generally restrict calorie intake not only result in fat loss but also loss of lean body mass, which lowers the basal metabolic rate and makes it difficult to sustain weight loss. If the diet is stopped, the weight immediately increases again, leading to failure in weight loss. It is generally recognized as easy, and it is considered that in order to prevent and treat obesity, a diet that restricts calorie intake should be combined with moderate to moderate exercise.

However, there is still a significant lack of research on personalized diets and long-term diets accompanied by scientific evidence for the calorie-restricted diet itself to effectively prevent, manage, or treat overweight or obesity, so treatment of obesity with a calorie-restricted diet It is necessary to confirm effectiveness and accurately confirm safety regarding side effects or problems that have previously been raised.

In addition, with the improvement of living standards, increased awareness of personal health care, and the development of smart devices and personal healthcare systems, individuals can achieve weight loss and obesity through commercialized healthcare applications or wearable devices instead of through medical institutions. Although there is a trend of trying to manage obesity, the development of applications or digital therapeutics that have been proven effective in treating obesity is still limited.

Accordingly, in the management and treatment of overweight or obesity, the development and provision of a reliable weight loss method or obesity treatment method supported by clinical trial results using a long-term calorie-restricted diet and commercialized digital treatment devices and applications to perform the same are necessary. It is required.

Republic of Korea Patent Publication KR 10-2301225 Republic of Korea Patent Publication KR 10-2330705 Republic of Korea Patent Publication KR 10-2362939 Republic of Korea Registered Patent Publication KR 10-2422591

The present invention is intended to solve the above needs and overcome the problems of the prior art, and is a computer readout method for preventing, managing, or treating overweight or obesity through a calorie-restricted diet and a long-term diet confirmed by clinical trials using the same. The purpose is to provide programs and digital treatment devices stored on possible recording media.

Another object of the present invention is to provide a method for preventing, managing, or treating overweight or obesity through a calorie-restricted diet and a long-term diet confirmed by clinical trials using the same.

The purpose of the present invention and the technical problems to be solved by the present invention are not limited to the problems mentioned above, and problems not mentioned will become clearer through the following description of the invention together with the claims and drawings described in this specification. . In addition, other tasks not mentioned in this specification include those that can be clearly understood and inferred by a person with ordinary knowledge in this technical field (hereinafter referred to as a 'person skilled in the art').

In order to achieve the above object, the present inventors administered a calorie-restricted diet supplemented with a high content of protein in overweight or obese patients with a body mass index of 25 or more, or abdominal obesity patients with a waist circumference of 90 cm or more for men or 85 cm or more for women. After conducting the study in two major stages for 12 months, we sought to evaluate the degree of weight loss and maintenance, as well as the safety of the calorie-restricted diet.

As a result, the present inventors developed a calorie-restricted diet and a long-term diet that can prevent, manage, or treat overweight or obesity, and provided it to the user based on the user's ideal target weight, thereby helping the user in actual clinical practice. Goal weight loss; and preventing, managing, or treating overweight or obesity, and completed the present invention.

Accordingly, the following invention is provided herein.

The present invention provides a computer program for treating overweight or obesity.

As an example, a computer program for treating overweight or obesity according to the present invention may be a program or application stored in a computer-readable recording medium, and may cause steps or operations included in the computer program to be performed by a computing device, device, or device. It can be done.

As an example, the program stored in the computer-readable recording medium for treating overweight or obesity includes,

Combined with computing devices,

(a) a user information input step of receiving body information and dietary intake information from the user;

(b) an information processing step of calculating the user's target weight or obesity level from the input user information;

(c) providing a first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user;

(d) receiving changed information from the user, including whether to implement the provided first calorie-restricted diet and body information that has changed at the time of input by the user;

(e) a weight loss determination step of determining whether the target weight or obesity level has been achieved based on the user's changed body information; and

(f) a step of exchanging opinions between the user and the management server, where expert coaching, consultation, or management is performed to maintain the user's weight loss or obesity reduction.

Here, the physical information includes gender, age, height, weight, waist circumference, body mass index (BMI index), degree of obesity, body fat mass, lean body mass, muscle mass, weight history, disease history, eating habits, sleep time, occupation, general It may be one or more of the following: data on activity level, exercise status, complications of obesity, and medical test results;

The body information that has changed at the time of the user's input may be one or more of weight, waist circumference, body fat mass, lean body mass, muscle mass, and bone density, and may further include adverse reactions.

The first calorie-restricted diet is provided as a calorie-restricted replacement meal of about 180 to 220 Kcal for one to three of the three regular meals every day, for a total of 600 to 1,500 Kcal or 1,500 to 1,800 Kcal per day, preferably. A calorie-restricted diet of 1200 to 1500 Kcal, more preferably 600 to 800 Kcal, may be provided. In addition, the first calorie-restricted diet may include 1.0 to 2.0 g, preferably 1.2 to 1.6 g, of protein per 1 kg of target body weight, and is maintained for at least 1 week or 1 to 16 weeks, preferably 2 weeks. It may be provided for from 12 weeks to 12 weeks, more preferably from 2 weeks to 8 weeks. However, it is not limited to this.

Specifically, the first calorie-restricted diet may be provided as a three-stage diet according to the total calories provided per day and the period of provision. In stage 1, all three regular meals a day are provided as calorie-restricted replacement meals of 180 to 220 Kcal, and a calorie-restricted diet of 600 to 800 Kcal per day is provided for 1 or 2 weeks, and stage 2 is provided after stage 1. The normal diet two times a day is replaced with a calorie-restricted alternative meal of about 180 to 220 kcal, and a calorie-restricted diet of a total of 1000 to 1200 kcal per day is provided for 6 to 7 weeks, and stage 3 is one regular meal a day after stage 2. The diet may include replacing a calorie-restricted diet with a total of about 180 to 220 kcal and providing a calorie-restricted diet with a total of 1,200 to 1,500 kcal per day for 7 to 9 weeks.

Additionally, the calorie-restricted alternative meal may be provided 2 to 8 times a day, preferably 3 to 6 times a day, and more preferably 3 to 4 times a day.

As an example, the program stored in the computer-readable recording medium for treating overweight or obesity includes,

In the step (f) of exchanging opinions between the user and the management server, where expert coaching, consultation or management is provided to maintain the user's weight loss or obesity reduction, additionally providing a second calorie-restricted diet to the user. It may include more.

Here, the second calorie-restricted diet is provided as a calorie-restricted alternative to the regular diet of about 180 to 220 Kcal for one to two meals a day for one to two weeks every month, and a total of 1200 to 1800 Kcal per day, preferably It may be characterized by providing a calorie-restricted diet of 1200 to 1500 Kcal, more preferably 1500 to 1800 Kcal.

The calorie-restricted alternative meal may be provided 1 to 4 times a day, preferably 1 to 2 times a day,

The second calorie-restricted diet may include 0.8 to 1.6 g, preferably 0.8 to 1.2 g, and more preferably 1.0 g of protein per 1 kg of the user's set target weight, and may be maintained for at least 4 weeks or 4 weeks. It may be provided for between 48 weeks, preferably between 24 and 48 weeks, and more preferably between 32 and 48 weeks.

As an example, the program stored in the computer-readable recording medium for treating overweight or obesity includes,

If it is determined that the target weight or obesity level has not been achieved in the (e) weight loss determination step of determining whether the target weight or obesity level has been achieved based on the user's changed body information, the first In order to provide the secondary calorie-restricted diet again, the step of returning to the first diet provision step (C) and further performing the step (C) of providing the first diet and (d) receiving the user's changed information It could be a way.

Here, the step (C) of providing the first diet and (d) the step of receiving the user's changed information may be performed at least one more time, preferably two or three more times.

The present invention provides a digital treatment device for treating overweight or obesity.

As an example, a digital treatment device for treating overweight or obesity according to the present invention includes a user device; and a management server.

Here, the user device may be a terminal device owned by a user who wishes to treat or manage overweight or obesity according to the present invention, and a program or application included in the digital treatment device of the present invention is installed and executed to connect to the management server. It may be possible,

The management server may connect one or more user devices or terminals owned by one or more users who wish to treat or manage overweight or obesity through an information and communication network according to the present invention.

As an example, the digital treatment device for treating overweight or obesity,

A user device including a user information input unit that receives the user's body information and dietary intake information, a display unit that displays information received from the management server, and a feedback performance unit that exchanges opinions with the management server; and

An information receiving unit that receives information input from the user, an information processing unit that calculates the user's target weight or obesity level from the received information and determines whether the target weight or obesity level has been achieved, and a calorie-restricted diet to be provided to the user. A diet decision unit that generates information, an information transmission unit that transmits information to be provided to the user device, a feedback management unit that provides expert coaching, consultation, or management instructions to the user and interacts with the user, and a database that collects or stores information. It may include a management server including;

Here, the diet decision unit determines a first calorie-restricted diet and/or a second calorie-restricted diet provided to the user to achieve the user's target weight or obesity level and maintain continuous weight loss, and the first calorie-restricted diet is provided to the user. Includes determination of dietary regimen for primary and/or secondary calorie restricted diet.

The first calorie-restricted diet is provided as a calorie-restricted alternative meal of about 180 to 220 kcal for one to three of the three regular meals a day, and a total of 1500 to 1800 Kcal, or 1200 to 1500 Kcal, or 600 to 600 kcal per day. A calorie-restricted diet of 800 Kcal may be provided for 1 to 16 weeks, 2 to 12 weeks, or 2 to 8 weeks. Additionally, the first calorie-restricted diet may include 1.0 to 2.0 g, or 1.2 to 1.6 g, or 1.5 g of protein per 1 kg of target body weight.

The second calorie-restricted diet is provided as a calorie-restricted replacement for about 180 to 220 Kcal per day for one to two meals a day for one to two weeks every month, and a total of 1200 to 1800 Kcal per day, or 1200 to 1500 Kcal. , or a calorie-restricted diet of 1500 to 1800 Kcal may be provided for 4 to 48 weeks, 24 to 48 weeks, or 32 to 48 weeks. Additionally, the second calorie-restricted diet may include 0.8 to 1.6 g, or 0.8 to 1.2 g, or 1.0 g of protein per 1 kg of the user's set target weight.

The calorie-restricted alternative meal may be provided 2 to 8 times a day, 3 to 6 times a day, 3 to 4 times a day, 1 to 4 times a day, or 1 to 2 times a day.

As an example, the information processing unit may include determining whether the user has implemented the first calorie-restricted diet provided to the user and whether the user has achieved the target weight or obesity by receiving body information that has changed at the time of the user's input. You can.

The body information that has changed at the time of the user's input may be one or more of weight, waist circumference, body mass index (BMI index), obesity level, body fat mass, lean body mass, muscle mass, and bone density, and may further include adverse reactions.

As an example, the digital treatment device for treating overweight or obesity according to the present invention may be implemented through a computing device such as a notebook, desktop, or laptop, or a mobile electronic device such as a smartphone, smart pad, or tablet PC.

The present invention provides a method for managing overweight or obesity.

As an example, the method for managing overweight or obesity according to the present invention,

A weight loss step to achieve a target weight or obesity level calculated based on the user's body information; and

It includes; maintaining or managing the user's weight.

As an example, the method for managing overweight or obesity includes,

(a) the user entering body information and dietary intake information;

(b) receiving information entered by the user and calculating a target weight or obesity level from the received information;

(c) providing a first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user;

(d) inputting whether the user has implemented the first calorie-restricted diet provided and body information that has changed at the time of the user's input;

(e) determining whether the target weight or obesity level has been achieved based on the user's changed body information; and

(f) providing expert coaching, consultation, or management to maintain the user's weight loss or obesity reduction,

Here, the first calorie-restricted diet is provided as a calorie-restricted alternative meal of about 180 to 220 kcal for one to three of the three regular meals a day, and a total of 1500 to 1800 Kcal per day, or 1200 to 1500 Kcal, or A calorie-restricted diet of 600 to 800 Kcal may be provided for 1 to 16 weeks, 2 to 12 weeks, or 2 to 8 weeks. Additionally, the first calorie-restricted diet may include 1.0 to 2.0 g, or 1.2 to 1.6 g, or 1.5 g of protein per 1 kg of target body weight.

The calorie-restricted alternative meal may be provided 2 to 8 times a day, preferably 3 to 6 times a day, and more preferably 3 to 4 times a day.

As an example, the method for managing overweight or obesity includes,

The method may further include providing a second calorie-restricted diet to the user in the step (f) where expert coaching, counseling, or management is provided to maintain the user's weight loss or reduction in obesity.

Here, the second calorie-restricted diet is provided as a calorie-restricted alternative to the regular diet of about 180 to 220 Kcal for one to two meals a day for one to two weeks every month, and a total of 1200 to 1800 Kcal per day, or 1200 to 1200 Kcal. A calorie-restricted diet of 1500 Kcal, or 1500 to 1800 Kcal, may be provided for 4 to 48 weeks, 24 to 48 weeks, or 32 to 48 weeks. Additionally, the second calorie-restricted diet may include 0.8 to 1.6 g, or 0.8 to 1.2 g, or 1.0 g of protein per 1 kg of the user's set target weight.

The calorie-restricted alternative meal may be provided 1 to 4 times a day, or 1 to 2 times a day.

As an example, the method for managing overweight or obesity includes,

In the step (e) of determining whether the target weight or obesity level has been achieved based on the changed body information of the user, if it is determined that the target weight or obesity level has not been achieved, the first calorie-restricted diet is provided to the user. In order to provide again, the method may be to return to step (C) and perform steps (C) and (d) one, two, three or more additional times.

As an example, the method for managing overweight or obesity may be a method performed by a computing device or a mobile electronic device.

The program and digital treatment device stored in a computer-readable recording medium for treating overweight or obesity according to the present invention, and the method for managing overweight or obesity, include providing a calorie-restricted diet based on the user's ideal target weight or target obesity level. By providing the user with a customized diet for a long period of time, the user's target weight loss can be achieved clinically; And it has the effect of preventing, managing or treating overweight or obesity.

The computer program and method for treating overweight or obesity of the present invention demonstrate the safety of a calorie-restricted diet with an excellent initial weight loss effect, and also have an excellent maintenance rate of lost weight, making it an effective treatment for overweight or obesity using a safe calorie-restricted diet. It can be used as an obesity treatment program and/or weight management or control method.

Figure 1 is an example showing a flowchart of execution steps of a program for treating overweight or obesity provided by the present invention.
Figure 2 shows an embodiment including a feedback cycle according to evaluation of goal achievement in the performance stage of the program for treating overweight or obesity provided by the present invention.
Figure 3 is a representative example diagram showing the configuration of a digital treatment device for treating overweight or obesity provided by the present invention.
(a) shows the connection between the user device and the management server included in the digital treatment device through an information communication network, and (b) shows the components included in the user device and the management server, respectively.
Figure 4 is an example diagram of an opinion exchange screen between a user and a management server showing the results of expert coaching, consultation, or management provided by a program for treating overweight or obesity according to an embodiment of the present invention.
Figure 5 shows the results of weight change over 12 months in the control group and the test group confirmed by an embodiment of the program for treating overweight or obesity provided by the present invention.
Figure 6 shows the results of changes in waist circumference over 12 months in the control group and test group confirmed by an example of the program for treating overweight or obesity provided by the present invention.
Figure 7 shows the results of changes in body fat mass over 12 months in the control group and the test group confirmed by an example of the program for treating overweight or obesity provided by the present invention.
Figure 8 shows the results of changes in lean body mass over 12 months in the control group and the test group confirmed by an example of the program for treating overweight or obesity provided by the present invention.

Hereinafter, the present invention will be described in detail through definitions of terms, specific examples, and examples. It should be noted that the above specific examples and embodiments include some implementations of the invention and do not include all implementations. It is obvious that the content of the invention disclosed by this specification is not limited to the specific embodiments described herein, and includes various implementations that can be implemented by those skilled in the art in the technical field to which the present invention pertains.

[Term Definition]

Definitions of key terms used in this specification are as follows.

Goal weight or obesity level

As used herein, the term “target weight or obesity level” means “target weight or target obesity level,” and in the present invention, the target weight and target obesity level are set as follows.

“Target weight” is defined as the most appropriate weight for maintaining health in daily life and corresponds to “standard weight,” a concept commonly used. In this specification, target weight is similar to standard weight, normal weight, or ideal weight. They have meaning and can be used interchangeably. For example, the standard weight for men is Height(m) Х Height(m) Х 22; For women, it can be calculated as Height(m) Х Height(m) Х 21;

“Target obesity level” can be calculated based on body mass index (BMI), i.e. body weight divided by the square of height, or Percent of Ideal Body Weight (PIBW), for example The target obesity level can be set to a BMI index range in the “normal range” rather than overweight or obesity.

user

As used herein, the term "user" refers to a computer program or application for the treatment of overweight or obesity, a digital treatment device, and a management device for the treatment of overweight or obesity provided by the present invention for the prevention, management or treatment of overweight or obesity. It is a concept that includes all objects that use or execute a method.

In one embodiment, the user may be a human, and in a specific embodiment, the user may be an overweight or obese person, a person with metabolic syndrome or a non-disease, or a normal person.

Calorie-restricted alternative and regular meals

The term "calorie-restricted alternative meal" used herein is a term that is distinct from the normal meal that the user consumes on a daily basis, that is, a "regular meal", and is a meal with calories of about 180 to 220 kcal per serving. It refers to a meal replacement meal. Here, the term "general meal" used in the present invention refers to a general meal that can be eaten in any form and has about 600 to 800 kcal per serving.

Specifically, the calorie-restricted alternative meal may be provided in the form of meal replacement powder, shake, or soup, and may be provided as a recipe containing protein, essential amino acids, dietary fiber, lactic acid bacteria, multivitamins, and minerals such as magnesium and zinc. For example, the calorie-restricted alternative diet includes calcium caseinate, milk protein concentrate, whey protein concentrate, soy protein isolate, amino acid mixture (50% L-leucine, 25% L-isoleucine, 25% L-valine), and vitamin D3 mix. Preparation, vitamin B6 hydrochloride, vitamin C, vitamin E mixed preparation, vitamin B1 hydrochloride, modified starch (sodium octenyl succinate starch), dextrin, crystalline cellulose, lactic acid mycelia, soy lecithin, zinc oxide, nicotinic acid amide, calcium pantothenate and folic acid. etc. may be included, and carbohydrates and fat may be included in small amounts to meet about 180 to 220 kcal per serving of the calorie-restricted alternative meal.

In addition, the calorie-restricted alternative diet is one of the first and/or second calorie-restricted diets in the computer program or application for the treatment of overweight or obesity, the digital treatment device, and the management method for the treatment of overweight or obesity according to the present invention. It is provided at the time of provision, and its characteristic is that the number of times it is provided in place of a regular meal varies depending on the total daily calories that must be provided to the user.

~ part

The term “~ unit” used in this specification refers to a unit that processes at least one function or operation, which may be implemented as hardware or software, or as a combination of hardware and software. Additionally, one “~ part” may be realized through two or more hardware, and two or more “~ parts” may be realized through one hardware.

device

As used herein, the term "device" may be used interchangeably with device or appliance, and some of the operations or functions described in this specification as performed by the device or performed by the device may be performed by a server connected to the device. It can be performed instead in . Here, the device includes computing devices such as notebooks, desktops, and laptops, or mobile electronic devices such as smartphones, smart pads, and tablet PCs.

1st, 2nd

Terms such as first and second used in this specification may be used to describe various components, but the components should not be limited by the terms. The above terms are used only for the purpose of distinguishing one component from another.

include

As used herein, the term "include" means that, unless otherwise stated, it does not exclude other components but may further include additional components or steps.

Unless otherwise defined, as used herein, singular expressions include plural expressions unless the context clearly dictates otherwise, and all technical and scientific terms are as commonly understood by a person skilled in the art to which the invention pertains. have the same meaning. All publications, patents, and other references mentioned herein are incorporated by reference in their entirety.

Hereinafter, specific details of the invention will be described through representative examples and drawings.

[Example]

Example 1. Computer Program for Treating Overweight or Obesity

The present invention provides a computer program for treating overweight or obesity.

In one embodiment, the computer program for treating overweight or obesity includes a program or application that can be executed through various components including software programming or software elements on a digital device, device, or device. A computer program or application according to the present invention can be mounted on a user terminal.

The program specifically includes a computer program or application recorded or stored in a computer-readable recording medium. Here, the recording medium may include hard disk, floppy disk, magnetic tape, CD-ROM, DVD, floptical disk, ROM (Read Only Memory), RAM (Random Access Memory), flash memory, etc. , but is not limited to this.

1 is a diagram schematically showing the overall execution steps of a computer program for treating overweight or obesity according to an embodiment of the present invention.

Referring to Figure 1, the computer program for treating overweight or obesity includes a user information input step (S100) of receiving body information and intake diet information from the user in combination with a computing device; An information processing step (S200) of calculating the user's target weight or obesity level from the input user information; A first diet provision step (S300) of providing a customized first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user; A step (S400) of receiving changed information from the user, including whether to execute the provided first calorie-restricted diet and body information that has changed at the time of input by the user; A weight loss determination step (S500) of determining whether the target weight or obesity level has been achieved based on the user's changed body information; and an opinion exchange step (S600) between the user and the management server in which expert coaching, consultation, or management is performed to continuously maintain the user's weight loss or reduction in obesity.

Referring to FIG. 2 as another embodiment, the computer program for treating overweight or obesity according to the present invention is a weight loss program that determines whether the target weight or obesity level has been achieved based on the user's changed body information. If it is determined in the determination step (S500) that the target weight or obesity level has not been achieved, the process returns to the first diet provision step (S300) to provide the first calorie-restricted diet to the user again. The first diet provision step (S300); and a step of receiving changed information from the user (S400).

Here, the step (C) of providing the first diet and (d) the step of receiving the user's changed information may be performed at least one more time, preferably two or three more times.

In addition, the computer program for treating overweight or obesity according to the present invention includes an opinion exchange step between the user and the management server in which expert coaching, consultation, or management is performed to continuously maintain the user's weight loss or reduction in obesity (Figure 1 (see S600) may further include providing a customized second calorie-restricted diet to the user (S601).

Hereinafter, the above according to the present invention Each execution step of a computer program or application for treating overweight or obesity is explained in detail.

Example 1-1. User information input step (S100)

The computer program or application for treating overweight or obesity provided by the present invention includes the step of receiving user information.

Here, the user's information includes the user's body information and intake diet information input by the user. Specifically, the user's own physical information and daily life measured before using the program or application for the purpose of losing weight or treating obesity by using the computer program or application for treating overweight or obesity according to the present invention. Includes information on typical and average intake diets.

The above physical information includes gender, age, height, weight, waist circumference, body mass index (BMI index), obesity level, body fat measurement data, weight history, past or currently ongoing diseases, eating habits, sleep time, occupation, and general information. It may be one or more of information about activity level, exercise status, and medical test results. Additionally, the physical information may further include one or more of smoking history, drinking history, blood pressure, pulse rate, disease treatment history, medication, combination therapy, or major surgery history.

Here, the body fat measurement data may be body fat mass, lean body mass, muscle mass, or fat mass, and the information regarding the medical test results may include one or more of data related to serological test results, imaging test results, etc. Specifically, it may include one or more of cholesterol level, triglyceride level, fasting blood sugar level, glycated hemoglobin level, bone density, liver level, abdominal ultrasound, CT and MRI data, etc., but is not limited thereto.

Additionally, the medical test results may be entered directly by the user or automatically received through linking with electronically stored electronic medical record data. Preferably, the electronically stored medical test data may be Electronic Medical Record (EMR) data or Electronic Health Record (EHR) data.

The intake diet information may be one or more of intake diet information such as staple food, side dishes, snacks, eating out, water, fruit, alcohol, etc., and information on total daily calorie intake, meal time, and meal pattern.

Example 1-2. Information processing step (S200)

The computer program or application for treating overweight or obesity provided by the present invention includes an information processing step of calculating the user's target weight or obesity level from user information input by the user.

Here, the user's target weight or obesity level for treating overweight or obesity may be set as follows based on the user's height and weight.

The target weight may be set to correspond to the standard weight. Specifically, in the present invention, the target weight is, for men, height (m) Х height (m) Х 22; For women, it can be calculated as height (m) Х height (m) Х 21; or it can be calculated using Broca's method.

The target obesity level can be calculated according to the body mass index (BMI), which is the value of one's body weight divided by the square of the height, or the Percent of Ideal Body Weight (PIBW) standard.

Specifically, the calculation of obesity using body mass index (BMI) is kg/㎡, and the target obesity is the BMI index range in the "normal range" rather than overweight or obesity in the obesity according to the World Health Organization (WHO) standards shown in Table 1 below. It can be set to .

Obesity classification (based on BMI index) 40.0 or more severe obesity 30.0-39.9 obesity 25.0-29.9 overweight 18.5-24.9 normal less than 18.5 underweight

In addition, obesity level using percentage (%) of standard body weight is calculated using (your weight You can set your target obesity level.

Obesity classification (PIBW standard) ≥ 200 morbid obesity >120 obesity 111~120 overweight 90~110 normal 80~90 underweight

Example 1-3. First meal provision step (S300)

The computer program or application for treating overweight or obesity provided by the present invention provides a customized first calorie restriction diet suitable for the user to reduce the user's weight based on the calculated target weight or obesity level of the user. Includes the first meal provision stage.

Here, the first calorie-restricted diet includes recommended foods, restricted foods, and/or grains, fish and meat, vegetables, fruits, milk, fats and oils, alcohol, It may consist of a diet containing salt, etc. In particular, one to three of the three regular meals a day are provided as calorie-restricted replacement meals of about 180 to 220 Kcal, for a total of 600 to 1,500 Kcal or 1,500 to 1,800 Kcal, preferably 1,200 to 1,500 Kcal, more per day. Preferably, a calorie-restricted diet of 600 to 800 Kcal may be provided. However, it is not limited to this.

In addition, since the calorie-restricted alternative meal is provided in packaging units of about 180 to 220 Kcal, it is easy to provide a customized calorie-restricted diet, and the calorie-restricted alternative meal is provided 2 to 2 times a day depending on the total daily calories to be provided. It may be provided 8 times, preferably 3 to 6 times a day, and more preferably 3 to 4 times a day.

Example 1-4. User's changed information reception stage (S400) and weight loss judgment stage (S500)

The computer program or application for treating overweight or obesity provided by the present invention includes the steps of receiving changed information from the user, including whether to execute the first calorie-restricted diet provided by the user and receiving changed body information at the time of input by the user; and a weight loss determination step of determining whether the target weight or obesity level has been achieved based on the user's changed body information.

Here, the body information that has changed at the time of the user's input may be one or more of weight, waist circumference, body fat mass, lean body mass, muscle mass, and bone density, and may further include adverse reactions.

In addition, the computer program or application for treating overweight or obesity according to the present invention may apply the above-mentioned first diet when it is determined that the user has failed to lose weight and/or achieve the target weight or obesity level based on the changed body information. The execution step is set to return to the provision step (S300), whereby the user is again provided with a customized first calorie-restricted diet suitable for achieving his or her target weight or obesity level. As a result, among the steps of performing the computer program or application for treating overweight or obesity according to the present invention, the step of providing the first diet (S300) and the step of receiving the user's changed information (S400) are further performed. This may be a method. At this time, the steps (C) of providing the first diet and (d) of receiving the user's changed information may be performed at least one more time, preferably two or three times.

Examples 1-5. Opinion exchange stage between management servers (S600)

The computer program or application for treating overweight or obesity provided by the present invention includes an opinion exchange step between a user and a management server in which expert coaching, consultation, or management is performed to continuously maintain the user's weight loss or reduction in obesity.

Here, the expert coaching, consultation, or management motivates the user to perform a calorie-restricted diet to maintain weight loss or obesity reduction, and provides calorie information for each food or alternative low-calorie foods, desirable lifestyle habits, or eating habits. It may include a variety of education, recommendations, counseling and/or nutritional counseling.

In addition, in the opinion exchange stage between the user and the management server, the method further includes providing a second calorie-restricted diet to the user to prevent weight gain or weight gain that may occur during a long-term weight loss maintenance period. You can.

Here, the second calorie-restricted diet is provided as a calorie-restricted alternative to the regular diet of about 180 to 220 Kcal for one to two meals a day for one to two weeks every month, and a total of 1200 to 1800 Kcal per day, preferably A calorie-restricted diet of 1200 to 1500 Kcal, more preferably 1500 to 1800 Kcal, may be provided. At this time, during the weight loss maintenance period, if the body weight increases by 2kg from the target weight, the period during which the second calorie-restricted diet is provided may be added by 1 week, and if the body weight increases by 4kg, the period for which the second calorie-restricted diet is provided may be added by 2 weeks.

The calorie-restricted alternative meal may be provided 1 to 4 times a day, preferably 1 to 2 times a day,

The second calorie-restricted diet may include 0.8 to 1.6 g, preferably 0.8 to 1.2 g, and more preferably 1.0 g of protein per 1 kg of the user's set target weight, and may be maintained for at least 4 weeks or 4 weeks. It may be provided for between 48 weeks, preferably between 24 and 48 weeks, and more preferably between 32 and 48 weeks.

In one specific embodiment, the computer program or application for treating overweight or obesity according to the present invention is a 4-month intensive calorie-restricted replacement diet program (performing the first calorie-restricted diet) with the calorie-restricted diet-based diet. Afterwards, an 8-month intermittent calorie-restricted alternative diet maintenance program (performing the second calorie-restricted diet above) can be performed.

In the 4-month intensive calorie-restricted alternative diet program, the calorie-restricted alternative diet was broadly divided into stages 1 to 3 and was provided for a total of 4 months,

Phase 1 was conducted for 1 to 2 weeks after starting the program, and all three meals a day were replaced with 3-4 calorie-restricted replacement meals of approximately 180 to 220 kcal, for a total of 600 to 800 kcal per day. In the next phase 2, After the above stage 1 was performed for 6 to 7 weeks, two meals a day were replaced with 2-3 calorie-restricted replacement meals of about 180 to 220 kcal, providing a total of 1000 to 1200 kcal of food per day, and then stage 3. In this case, the second step was carried out for 9 to 7 weeks, and one meal per day was replaced with 1-2 calorie-restricted replacement meals of about 180 to 220 kcal, providing a total of 1200 to 1500 kcal of food per day.

Next, according to the 8-month intermittent calorie-restricted alternative maintenance program, two meals a day for one week per month were provided as calorie-restricted alternative meals of approximately 180 to 220 kcal, for a total of 1200 to 1500 Kcal or 1500 to 1800 Kcal per day. A restricted diet was provided. At this time, if the weight at the time of the user's input increased by more than 2kg than the set target weight, two additional meals of the calorie-restricted replacement meal were replaced for one more week, and if the weight increased by more than 4kg, it was continued for an additional two weeks.

The steps for configuring the computer program or application according to the present invention described above may be performed in an appropriate order, unless the order is explicitly stated or otherwise contrary to the description in the specification. The present invention is not necessarily limited by the order of description of the above steps.

Example 2. Digital treatment device for treating overweight or obesity

The present invention provides a digital treatment device for treating overweight or obesity.

Figure 3 is a diagram showing the configuration of a digital treatment device for treating overweight or obesity according to an embodiment of the present invention.

Referring to Figure 3, the digital treatment device for treating overweight or obesity according to the present invention includes a user device; and a management server.

Specifically, the user device includes a user information input unit that receives the user's body information and dietary intake information, a display unit that displays information received from the management server, and a feedback performance unit that exchanges opinions with the management server,

The management server provides the user with an information receiving unit that receives information input from the user, an information processing unit that calculates the user's target weight or obesity level from the received information, and determines whether the target weight or obesity level has been achieved. A diet decision unit that generates calorie-restricted diet information to be provided, an information transmission unit that transmits information to be provided to the user device, a feedback management unit that provides expert coaching, consultation, or management instructions to the user and interacts with the user, and collects or collects information. It may contain a database that is stored.

Hereinafter, the above according to the present invention The configuration of a digital treatment device for treating overweight or obesity is explained in detail.

Example 2-1. User Device(10)

The above according to the present invention The digital treatment device for treating overweight or obesity includes a user device 10, which may be a terminal device possessed by a user who wants to treat or manage overweight or obesity according to the present invention, and the digital treatment device of the present invention A program or application included in may be installed and executed and may be able to connect to the management server.

Specifically, the user device 10 according to the present invention receives the user's body information and intake diet information from the user, receives the target weight or obesity level from the management server, displays the information, and further sets the target weight or obesity level. Information on the calorie-restricted diet that must be achieved is provided and displayed, and it features the ability to exchange direct opinions in real time about expert coaching, education, and/or consultation provided from the management server.

According to an embodiment of the present invention, the user device 10 includes a user information input unit 11 that receives the user's body information and dietary intake information, a display unit 12 that displays information received from the management server, and management. It includes a feedback performing unit 13 that exchanges opinions with the server, where the user information input unit may function to receive input of the user's body information and dietary intake information.

Here, the user information input unit 11 functions to input the consumer's body information and dietary intake information, and through the user information input unit, the user can input information before and after performing the program for treating overweight or obesity according to the present invention. You can enter changed body information in the middle, that is, at the point of input. Additionally, the user information input unit 11 can be any input device such as a touch panel, keyboard, mouse, etc. without any particular restrictions.

The information regarding the consumer's body information and intake diet information includes all the contents described in the user information input step (S100) of Example 1-1 described above, and the body information changed at the time of input is the same as Example 1 described above. It includes all the contents written in the user's changed information reception step (S400) of -4.

The display unit 12 can be any output device without particular limitation that allows the consumer device 10 to output or display information input by the consumer and information provided from the management server 20, and the information input or provided is possible. They can be displayed on the screen of the user device in the form of numbers, pictures, photos, or graphs. Additionally, an interface that allows data to be transmitted and received can be provided.

The feedback executing unit 13 is implemented together with the feedback executing unit 25 configured in the management server 20, so that users receive real-time coaching and/or management guidelines from experts, consultation on difficulties, etc. It allows for direct exchange of opinions on motivation, etc.

Example 2-2. Management Server(20)

The above according to the present invention The digital treatment device for treating overweight or obesity includes a management server 20 in addition to the user device 10, wherein the management server 20 is configured to provide one or more users who want to treat or manage overweight or obesity according to the present invention. Connects multiple user devices or terminals owned by the user through an information and communication network, stores and manages information about the multiple users, and provides calorie-restricted diets, diet therapy, expert education and training to treat their overweight or obesity. /or can provide various information and feedback, such as consultation.

Additionally, the digital treatment device according to an embodiment of the present invention may be additionally connected to other systems or organs to implement services between the user device 10 and the management server 20.

Specifically, the management server 20 according to the present invention includes an information receiving unit 21 that receives information input from the user, calculates the user's target weight or obesity level from the received information, and determines whether the target weight or obesity level has been achieved. an information processing unit 22 that determines, a diet decision unit 23 that generates calorie-restricted diet information to be provided to the user, an information transmission unit 24 that transmits information to be provided to the user device, and expert coaching to the user. , it may include a feedback management unit 25 that provides consultation or management guidelines and interacts with users, and a database 26 that collects or stores information.

Here, information regarding calculation of the user's target weight or obesity level, calorie-restricted diet information and implementation method (e.g., diet) to be provided to the user, and expert coaching, consultation, or management instructions are described in the above-described Example 1- Includes all information described in sections 2 to 1-5.

The information receiving unit 21 performs the function of receiving information input from the user, and the information input from the user is received and stored depending on the point of input, and accordingly, the management server 10 of the present invention performs the function. The received information used when processing information can be used separately depending on the point of input.

The information processing unit 22 includes body information from the user provided by the information receiving unit before performing the first calorie-restricted diet; And comparing whether the user implemented the first calorie-restricted diet provided to the user and body information changed after performing the first calorie-restricted diet, and analyzing the results of the user's changed weight or obesity to determine whether the goal has been achieved. can do.

The diet decision unit 23 provides a product to the user to achieve the user's target weight or obesity level and/or maintain long-term continuous weight loss based on the target weight or obesity level calculated by the information processing unit 22. Determining a primary calorie-restricted diet and/or a secondary calorie-restricted diet, and determining a dietary regimen for the primary and/or secondary calorie-restricted diet.

The information transmission unit 24 functions to transmit information to be provided to the user device 10, where the information to be provided includes the user's target weight or obesity level, the first and/or second calorie-restricted diet, and diet regimen. This may apply

The feedback executing unit 25 of the management server is implemented together with the feedback executing unit 13 of the user device 10 and can provide direct opinions on expert coaching, education, and/or consultation to the user in real time.

An example of expert coaching or management guidelines implemented by the feedback performing unit of the present invention is shown in FIG. 4.

As shown in FIG. 4, the digital treatment device according to the present invention includes a feedback execution unit in the management server, thereby providing expert information based on the user's weight information, diet information, and simple exercise information provided according to the performance of the program for treating overweight or obesity. It can be seen that opinions are exchanged on coaching, motivation, encouragement, support, alternative diets, etc.

The database 26 stores body information and intake diet information input from the user device 10, target weight and/or obesity level calculated accordingly, and information on the first and second calorie-restricted diets provided to the user. You can. Additionally, the database 26 may store various setting values for running a program or application according to the present invention.

In addition, the information processing unit 22 and the diet decision unit 23 of the management server 20 according to the present invention select, determine, and/or select a user-customized calorie-restricted diet through learning and analysis of information collected by AI. Includes presentation.

Example 3. Methods for managing overweight or obesity

The present invention provides methods for managing overweight or obesity.

In one embodiment, the method for managing overweight or obesity includes the steps of: (a) a user inputting body information and dietary intake information; (b) receiving information entered by the user and calculating a target weight or obesity level from the received information; (c) providing a first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user; (d) inputting whether the user has implemented the first calorie-restricted diet provided and body information that has changed at the time of the user's input; (e) determining whether the target weight or obesity level has been achieved based on the user's changed body information; and (f) providing expert coaching, consultation, or management to maintain the user's weight loss or obesity reduction.

In another embodiment, the method for managing overweight or obesity includes:

It may further include providing a second calorie-restricted diet to the user in the step (f) where expert coaching, consultation, or management is provided to maintain the user's weight loss or obesity reduction,

In the step (e) of determining whether the target weight or obesity reduction has been achieved based on the user's changed body information, if it is determined that the target weight or obesity reduction has not been achieved, a first In order to provide the calorie-restricted diet again, the method may be to return to step (C) and further perform steps (C) and (d).

Here, step (a); The contents related to steps (f); calorie-restricted replacement diet and the first or second calorie-restricted diet and the regimen provided are the above-described contents in Example 1. Computer program for treating overweight or obesity Includes all.

Example 4. Results of a program to treat overweight or obesity

Example 4-1. Selection of participants in overweight or obesity treatment programs

In order to select subjects to participate in a program for treating overweight or obesity according to an embodiment of the present invention, the participating subjects or their representative agree to the clinical study protocol, clinical follow-up and methods, and the research review committee of the research institution approves it. Only those subjects who consented in writing to a clinical trial subject consent form were judged eligible to participate based on the selection and exclusion criteria.

First, the selection criteria is that participants must be Korean adults between 18 and 70 years old, overweight or obese with a body mass index (BMI index (kg/m ² )) of 25 or more, or body mass index of 23 or more. The criteria was those whose waist circumference was more than 90 cm for men and 85 cm for women, and those who met this were selected.

Next, among the selected subjects, those who met the exclusion criteria listed in Table 3 were excluded.

Exclusion criteria pregnant or lactating If you have taken medications that affect your weight within the past 6 months or participated in another weight loss program If there has been a weight change of more than 3kg within 6 months If you have undergone surgical surgery for weight loss Using medications that cause hypoglycemia, such as insulin or sulfonylurea Taking drugs prohibited in combination ^* Cases where it is difficult to perform exercise evaluation and exercise prescription due to cardiovascular disease, cancer history, or surgery If you have uncontrolled depression, bipolar, or schizophrenia If you have an eating disorder such as bulimia, anorexia, or binge eating disorder If you have an alcohol use disorder ^** Within 6 months of participating in the study, the glomerular filtration rate (eGFR), which reflects kidney function, was 30 ml/min.
In case of less than If you have gallstones or have visited the emergency room due to abdominal pain caused by gallstones

^* Drugs prohibited in combination include drugs or foods that may affect body weight, such as obesity treatments (orlistat, lorcaserin, liraglutide, phentermine, amphetamine, topiramate, bupropion, naltrexone), oral steroids, hormones, and body weight. Health functional foods for conditioning may be included. However, those who use antipsychotics, antidepressants, antiepileptic drugs, antidiabetic drugs, or antihistamines and have no change in weight for more than 6 months may be included in the selection.

^** This applies to those with a history of drinking more than 4 days per week and consuming more than 7 drinks at a time for men and 5 or more drinks at a time for women.

In addition, the number of subjects to participate in a program for treating overweight or obesity according to an embodiment of the present invention was calculated by considering the following matters.

According to a previous study conducted on obese patients with a body mass index of 30 or higher, the test group receiving a calorie-restricted diet was expected to lose an average of 9.4 kg (standard deviation 7), while the control group was expected to lose about 2.2 kg (standard deviation 5.4). Because it is expected to result in weight loss, if type 1 error and power are set to 5% and 90%, respectively, a total of 72 subjects, 36 in each group, are needed. Due to the nature of this clinical trial study, the dropout rate is high, so the dropout rate is 30. Considering the percentage, it was calculated that a total of 104 research subjects were needed, 52 in each group of test and control groups.

Accordingly, a total of 104 subjects who met the selection criteria to participate in a program to treat overweight or obesity were ultimately selected.

Example 4-2. Process of conducting an overweight or obesity treatment program

The test group and control group were each randomly assigned to only the final selected subjects according to the order of registration so that the characteristics of the subjects did not affect the allocation of the test group. The randomization method for this purpose was the baseline covariate adaptive randomization method proposed by James (1998), taking into account the implementing organization, gender, age, and body mass index stage. Gender, age, and baseline body mass index were used. A 1:1 procedure was conducted using stratified block randomization.

Here, the control group is a dietary education group based on a calorie-restricted diet, in which a total of 1200 to 1800 kcal of food is provided per day, and the calorie-restricted diet-based education and moderate exercise are recommended, and continuous weight loss is performed for 12 months. , the test group is a group that undergoes an 8-month intermittent calorie-restricted replacement meal maintenance program after a 4-month intensive calorie-restricted replacement meal program. Specifically, according to the 4-month intensive calorie-restricted alternative diet program, the test group was provided with calorie-restricted alternative diets broadly divided into stages 1 to 3 for a total of 4 months.

In one embodiment of the present invention, the first stage of the intensive calorie-restricted replacement meal program provided to the test group for 4 months is conducted for 2 weeks from the start of the clinical trial, and all three meals a day are provided with a calorie-restricted replacement meal of about 180 to 220 kcal. It was replaced 3-4 times, providing a total of 600-800 kcal of food per day, and stage 2 was performed for 6 weeks after performing stage 1, with two meals a day being a calorie-restricted alternative meal of about 180 to 220 kcal. 2-3 A total of 1000-1200 kcal of food was provided per day as a replacement circuit, and stage 3 was performed for 8 weeks after performing stage 2, and one meal per day was replaced with 1-2 calorie-restricted replacement meals of approximately 180 to 220 kcal. A total of 1200-1500 kcal of food was provided per day. At this time, protein was provided at 1.5 g/kg per set target weight.

Next, according to the 8-month intermittent calorie-restricted alternative meal maintenance program, the test group was provided with a calorie-restricted alternative meal of about 180 to 220 kcal two times a day for one week a month, and the remaining meal was protein through a regular meal. and vegetables, and for the next 3 weeks, a calorie-restricted diet of 1200 to 1800 kcal per day was followed as a diet to increase regular food.

However, if body weight increased by more than 2 kg during the period of carrying out the intermittent calorie-restricted alternative meal maintenance program, the two meals of the above-mentioned calorie-restricted alternative meal were replaced for one additional week, and if the weight increased by more than 4 kg, it was continued for an additional two weeks.

The calorie-restricted alternative diet provided to the test group included calcium caseinate, milk protein concentrate, whey protein concentrate, soy protein isolate, amino acid mixture (50% L-leucine, 25% L-isoleucine, 25% L-valine), and vitamin D3 mix. Preparation, vitamin B6 hydrochloride, vitamin C, vitamin E mixed preparation, vitamin B1 hydrochloride, modified starch (sodium octenyl succinate starch), dextrin, crystalline cellulose, lactic acid mycelia, soy lecithin, zinc oxide, nicotinic acid amide, calcium pantothenate and folic acid. It was provided in the form of a meal replacement shake or soup, and carbohydrates and fat were included in small amounts to meet about 180 to 220 kcal per serving of the calorie-restricted replacement meal.

On the other hand, the control group was educated on a standardized low-calorie diet with a total of 1200 to 1800 kcal per day for 12 months without providing the above-mentioned calorie-restricted alternative diet, and was encouraged to exercise and control their weight. In this case, expert training was provided on food-based low-calorie diet and exercise along with behavior modification therapy.

In both the test and control groups, a nutritionist checked the degree of compliance with the dietary regimen once or twice a week, educated and managed the dietary evaluation, and researchers confirmed compliance with the dietary regimen with a message once a week.

In one embodiment according to the present invention, the test group and the control group were evaluated on the degree of obesity, history of weight, history of disease, eating habits, sleep time, occupation, general activity level and exercise, and complications of obesity at the first visit. After confirming the target weight for 12 months, the goal was set based on the medically recommended weight. Accordingly, they were recommended the calorie-restricted alternative diet according to the present invention along with correction of problematic aspects of their eating habits, and were provided with educational materials for obesity classes. At the second visit, the amount of change is checked through weight and body composition measurements, comorbidities are checked, target calories are set, and a calorie-restricted alternative meal is provided accordingly; They were also advised to increase their activity level and exercise, and a nutritionist subsequently reviewed their food diaries and provided education on goal calorie setting and diet regimen. Afterwards, at each visit every two weeks, weight and body composition were measured, and evaluation was made to determine whether the patient adhered to the target calorie intake and the level of activity. In addition, they received coaching on whether there were obstacles to weight loss and how to deal with them, and they received advice from experts such as nutritionists to check their meal diaries, check and educate them on their diet, and receive advice on coping with problematic eating habits and difficulties. At the final visit of the clinical trial study, participants were assessed on whether they had achieved their goal weight and were provided with education and educational materials on how to maintain their weight loss.

In addition, the safety of the overweight or obesity treatment program according to the present invention was evaluated based on all adverse reactions. Each time each subject in the test or control group experienced an adverse reaction, it was recorded and told to the researcher during the interview, and all adverse reactions were also recorded in the case record. Abnormal changes in test values should be evaluated by the researcher for clinical significance and problems and recorded in the case record. Adverse reactions observed by the researcher, adverse reactions reported by the subjects, all adverse reactions shown in blood sugar levels or laboratory test values, and serious adverse reactions were recorded according to the procedures specified in this protocol.

Example 4-3. Comparison results of changes in physical information, including weight

According to one embodiment of the present invention, the physical information of the test group and the control group that underwent the overweight or obesity treatment program of Example 4-2 was collected before starting the program (Visit 1), at the start (Visit 2), and at 2 weeks. (Visit 3), 2nd month (Visit 4), 4th month (Visit 5), 6th month (Visit 6), 8th month (Visit 7), 10th month (Visit 8), and 12th month (Visit 9). At this time, the physical information included height, weight, waist circumference, body fat, lean body mass and body fat percentage, muscle mass, systolic blood pressure and diastolic blood pressure, and the body fat mass, lean body mass and body fat percentage were measured using bioelectrical impedance analysis (InBody 7.0). It was measured.

Statistical processing presented descriptive statistics for continuous variables and frequencies and ratios for categorical variables. All statistical tests were performed at a significance level of 0.05 or less and were two-sided. In addition, if the response variable did not satisfy the normality assumption, appropriate transformation was performed using rank transformation, etc., and changes in body weight, waist circumference, body fat mass, and lean body mass between the test group and the control group were analyzed using a t-test.

The results of comparing the average values of body weight, waist circumference, body fat mass, and lean body mass of the test group and the control group that underwent the overweight or obesity treatment program of Example 4-2 of the present invention are shown in Tables 4 to 7, respectively. .

As shown in Table 4 and Figure 5, in the test group, the average body weight was reduced by -8.11 kg in proportion to the period from the 2nd week to the 4th month of starting the program (corresponding to the 4-month intensive calorie-restricted replacement diet program period), and the program Even until the 12th month after starting (corresponding to the 8-month period of the intermittent calorie-restricted replacement diet maintenance program), the average weight loss was maintained at about -8.1 to about -7.3 kg.

On the other hand, in the control group, the average weight decreased gradually to -5.46 kg by the 4th month after starting the program, and the average weight lost was maintained at about -5.5 to about -4.7 kg until the 12th month after starting the program.

variable test group control group p value

weight
(kg) When to start
(Visit 2) 0 0 0 2nd week
(Visit 3) -4.17 -1.85 <0.001 2nd month
(Visit 4) -6.76 -4.14 0.001 4th month
(Visit 5) -8.11 -5.46 0.016 6th month (visit 6) -8.00 -5.56 0.046 8th month (visit 7) -7.90 -5.55 0.069 10th month (visit 8) -7.13 -5.00 0.115 Month 12 (Visit 9) -7.26 -4.73 0.082

Note: The average weight of the test group and control group before starting the program (Visit 1) was 83.02 kg and 84.35 kg, respectively, p-value was 0.701, and the average weight at the start (Visit 2) was 83.45 kg and 84.67 kg, respectively. , p-value was 0.727.

The above results show that the overweight or obesity treatment program according to the present invention caused significantly rapid weight loss in the early stages of program implementation by utilizing a calorie-restricted diet, and the reduction was achieved only with a relaxed calorie-restricted diet applied similarly to the control group over a long period of 12 months. This means that you can maintain your weight.

Furthermore, the results showed that the body weight of obese patients was reduced by about 9 to 10% compared to the initial body weight (in the case of the control group, the body weight was reduced by about 5 to 6% of the initial body weight), so the treatment of overweight or obesity according to the present invention It can be said that the program shows excellent therapeutic effects in treating obesity.

In addition, as shown in Table 5 and Figure 6, in the test group that performed the overweight or obesity treatment program according to the present invention, from the 2nd week to the 4th month after starting the program (corresponding to the 4-month intensive calorie restriction replacement program period) The average waist circumference decreased by -7.86 cm in proportion to the period, and by the 12th month after starting the program (corresponding to the 8-month intermittent calorie-restricted replacement diet maintenance program period), the waist circumference decreased further, with an average waist circumference of about -9.5 cm. It decreased to cm and then maintained a decrease of about -8 to -9 cm.

On the other hand, in the control group, the average waist circumference gradually decreased to -4.46 cm by 4 months after starting the program, and the reduced average waist circumference was maintained until 12 months after starting the program.

variable test group control group P value

waist
Circumference (cm) When to start
(Visit 2) 0 0 0 2nd week
(Visit 3) -3.58 -1.08 <0.001 2nd month
(Visit 4) -6.39 -3.04 <0.001 4th month
(Visit 5) -7.86 -4.46 0.001 6th month (visit 6) -7.73 -4.39 0.003 8th month (visit 7) -9.39 -4.76 0.010 10th month (visit 8) -7.62 -5.12 0.052 Month 12 (Visit 9) -8.94 -4.96 0.013

Note: The average waist circumference of the test group and control group before starting the program (Visit 1) was 99.67cm and 99.75cm, respectively, and the p-value was 0.973, and the waist circumference at the start (Visit 2) was 100.1cm and 99.36cm, respectively. and the p-value was 0.727.

Through the above results, the overweight or obesity treatment program according to the present invention shows a significantly rapid reduction in waist circumference, that is, the treatment of abdominal obesity, at the beginning of the program by utilizing a calorie-restricted diet, and is similar to the control group for a long period of time (12 months or more). It was confirmed that the reduced waist circumference was maintained only with the provided relaxed calorie-restricted diet.

Next, the effect of the overweight or obesity treatment program according to the present invention on changes in body fat mass is shown in Table 6 and Figure 7.

As for the change in body fat mass, the average body fat mass in the test group decreased by -6.41 kg from the 2nd week to the 6th month after starting the program, and the average reduction of about -6 kg was maintained well until the 12th month.

Meanwhile, in the control group, the average body fat mass decreased by -4.15 kg until the 4th month after starting the program, and the reduced average body fat mass was maintained until the 12th month thereafter.

variable test group control group P value

body fat mass
(kg) When to start
(Visit 2) 0 0 0 2nd week
(Visit 3) -1.94 -0.92 0.027 2nd month
(Visit 4) -5.10 -3.68 0.154 4th month
(Visit 5) -6.11 -4.15 0.070 6th month (visit 6) -6.41 -4.29 0.082 8th month (visit 7) -6.04 -4.31 0.167 10th month (visit 8) -5.38 -3.87 0.236 Month 12 (Visit 9) -5.68 -4.02 0.230

Note: The average body fat mass of the test group and control group before starting the program (Visit 1) was 31.8 Kg and 33.14 Kg, respectively, p-value was 0.494, and the average body fat mass at the start (Visit 2) was 31.76 Kg and 33.02 Kg, respectively. , p-value was 0.536.

Interestingly, as shown in Table 7 and Figure 8, the overweight or obesity treatment program according to the present invention did not show a significant effect in the test and control groups on changes in lean body mass.

variable test group control group P value

Lean body mass
(kg) When to start
(Visit 2) 0 0 0 2nd week
(Visit 3) -1.31 -1.49 0.873 2nd month
(Visit 4) -1.07 -1.64 0.620 4th month
(Visit 5) -1.39 -1.83 0.695 6th month (visit 6) -1.02 -1.76 0.505 8th month (visit 7) -1.17 -1.72 0.623 10th month (visit 8) -0.65 -1.43 0.535 Month 12 (Visit 9) -0.98 -1.50 0.668

Note: The average lean mass of the test and control groups before starting the program (Visit 1) was 28.42 kg and 28.40 kg, respectively, p-value was 0.985, and the average muscle mass at the start (Visit 2) was 28.74 kg and 29.6 kg, respectively. and the p-value was 0.605.

When compared and analyzed with the results of body weight and body fat reduced by the overweight or obesity treatment program, there is almost no decrease in muscle mass and significant weight loss due to reduction of body fat by the calorie-restricted diet and diet regimen according to the present invention. This can be explained by the weight loss.

In summary, the overweight or obesity treatment program according to an embodiment of the present invention involves a calorie-restricted diet consisting of a total daily calorie intake of 600 Kcal for women and 800 Kcal for men for the first 2 weeks, and then for the next 6 weeks and 8 weeks, respectively. Four months of a standardized low-calorie diet (caloric restriction limited to approximately 1200 to 1800 Kcal) followed by a calorie-restricted diet of approximately 1000 to 1200 Kcal and 1.5 g of protein per kilogram of target body weight, respectively. Compared to the control group that received the diet), the initial weight and body fat loss effect was effective, and there was little difference in muscle mass loss.

In addition, a maintenance program conducted for the following 8 months (the control group is recommended a calorie-restricted diet limited to about 1200 to 1800 Kcal, and the test group is provided a calorie-restricted diet limited to about 1200 to 1500 Kcal or about 1500 to 1800 Kcal, in this case It was found that the reduced body weight and body fat were significantly maintained by receiving 1g of protein per 1kg of target body weight.

Furthermore, the overweight or obesity treatment program according to an embodiment of the present invention is expected to be implemented as one of the methods for treating overweight or obesity that can be relatively safely performed on an outpatient basis without any complaints of serious side effects. do.

The contents described above are specific embodiments for carrying out the present invention, and the present invention includes not only the above-described embodiments, but also embodiments that can be simply changed or easily changed in design. In addition, the present invention also includes techniques that can be easily modified and implemented using the embodiments. Accordingly, the scope of the present invention is not limited to the above-described embodiments, but is determined by the claims and equivalents of the present invention as well as the claims described below.

10 user devices
11 User information input section
12 Display unit
13 Feedback implementation department
20 Management Server
21 Information receiver
22 Information Processing Department
23 Diet decision section
24 Information transmission unit
25 Feedback Management Department
26 database

Claims (15)

Combined with computing devices,
(a) a user information input step of receiving body information and dietary intake information from the user;
(b) an information processing step of calculating the user's target weight or obesity level from the input user information;
(c) providing a first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user;
(d) receiving changed information from the user, including whether to implement the first calorie-restricted diet provided by the user and receiving changed body information at the time of input by the user;
(e) a weight loss determination step of determining whether the target weight or obesity level has been achieved based on the user's changed body information; and
(f) an opinion exchange step between the user and the management server in which expert coaching, consultation, or management is performed to continuously maintain the user's weight loss or obesity reduction according to the results of the weight loss determination step; And
(g) additionally providing a second calorie-restricted diet to the user according to the results of the weight loss determination step,
Here, the physical information includes gender, age, height, weight, waist circumference, body mass index (BMI index), degree of obesity, body fat mass, lean body mass, muscle mass, weight history, disease history, eating habits, sleep time, occupation, general Includes one or more of the following data: activity level, exercise status, obesity complications, and medical test results,
The body information that has changed at the time of the user's input includes one or more of weight, waist circumference, body fat mass, lean body mass, muscle mass, and bone density,
In the first calorie-restricted diet, one to three of the three regular meals a day are provided as calorie-restricted replacement meals of 180 to 220 Kcal, for a total of 1000 to 1200 Kcal or 600 to 800 Kcal per day. provided,
The second calorie-restricted diet is provided as a calorie-restricted replacement for 180 to 220 Kcal of the regular diet for one to two meals a day for 1 to 2 weeks every month, with a total of 1200 to 1500 Kcal or 1500 to 1800 Kcal per day. Characterized by providing a restricted diet,
A program stored on a computer-readable recording medium for treating overweight or obesity.
According to paragraph 1,
The first calorie-restricted diet includes 1.0 to 2.0 g or 1.2 to 1.6 g of protein per 1 kg of the user's set target weight,
A program stored on a computer-readable recording medium for treating overweight or obesity.
According to paragraph 1,
The first calorie-restricted diet is provided as a calorie-restricted alternative meal of 180 to 220 Kcal for all three regular meals a day, and a calorie-restricted diet of 600 to 800 Kcal per day is provided for 1 week or 2 weeks. ,
A program stored on a computer-readable recording medium for treating overweight or obesity.
According to paragraph 1,
The first calorie-restricted diet is provided as a two-stage diet according to the total calories provided per day and the period of provision,
In the first stage, a calorie-restricted diet of 180 to 220 Kcal is provided for all three regular meals every day, and a calorie-restricted diet of 600 to 800 Kcal per day is provided for one or two weeks;
In step 2, after step 1, the normal diet twice a day is replaced with a calorie-restricted alternative meal of 180 to 220 kcal, and a calorie-restricted diet of 1000 to 1200 kcal per day is provided for 6 to 7 weeks.
A program stored on a computer-readable recording medium for treating overweight or obesity.
delete According to paragraph 1,
The second calorie-restricted diet is provided for 24 to 48 weeks or 32 to 48 weeks,
A program stored on a computer-readable recording medium for treating overweight or obesity.
According to paragraph 1,
The second calorie-restricted diet includes 0.8 to 1.6 g or 0.8 to 1.2 g of protein per 1 kg of the user's set target weight,
A program stored on a computer-readable recording medium for treating overweight or obesity.
According to paragraph 1,
If it is determined that the target weight or obesity level has not been achieved in the (e) weight loss determination step of determining whether the target weight or obesity level has been achieved based on the user's changed body information, the first In order to provide the secondary calorie-restricted diet again, it includes returning to the step (C) of providing the first diet and further performing the step of providing the first diet (C) and (d) receiving the user's changed information. do,
Here, the step (C) of providing the first diet and (d) the step of receiving the user's changed information are performed one, two or three more times,
A program stored on a computer-readable recording medium for treating overweight or obesity.
A user information input unit that receives the user's body information and dietary intake information,
A display unit that displays information received from the management server, and
A user device including a feedback executing unit that exchanges opinions with the management server; and
An information receiving unit that receives information input from the user,
An information processing unit that calculates the user's target weight or obesity level from the received information and determines whether the target weight or obesity level has been achieved;
a diet determination unit that generates calorie-restricted diet information to be provided to the user;
an information transmitting unit that transmits information to be provided to the user device;
A feedback management department that interacts with users by providing expert coaching, consultation, or management guidance to said users; and
Includes a management server that includes a database that collects or stores information,
Here, the diet decision unit determines a first calorie-restricted diet or a second calorie-restricted diet provided to the user to achieve the user's target weight or obesity level and maintain continuous weight loss, and determines the first calorie-restricted diet. Determine the dietary regimen of the restricted diet or the second calorie-restricted diet,
In the first calorie-restricted diet, one to three of the three regular meals a day are provided as calorie-restricted replacement meals of 180 to 220 Kcal, for a total of 1000 to 1200 Kcal or 600 to 800 Kcal per day. provided,
The second calorie-restricted diet is provided as a calorie-restricted alternative to 180 to 220 Kcal of the regular diet for one to two meals a day for one to two weeks every month, with a total of 1200 to 1500 Kcal or 1500 to 1800 Kcal per day. Characterized by providing a restricted diet,
A digital therapeutic device for treating overweight or obesity.
According to clause 9,
The physical information includes gender, age, height, weight, waist circumference, body mass index (BMI index), obesity level, body fat mass, lean body mass, muscle mass, weight history, disease history, eating habits, sleep time, occupation, general activity level, Includes one or more of the following data: whether or not you exercise, whether there are complications of obesity, and medical test results,
The body information changed at the time of the user's input includes one or more of weight, waist circumference, body fat mass, lean body mass, muscle mass, and bone density,
A digital therapeutic device for treating overweight or obesity.
According to clause 9,
The first calorie-restricted diet is provided for 1 to 16 weeks, 2 to 12 weeks, or 2 to 8 weeks, wherein the first calorie-restricted diet provides 1.0 protein per kg of target body weight. Containing from 2.0 g, or 1.2 to 1.6 g, or 1.5 g,
The second calorie-restricted diet is provided for 4 to 48 weeks, 24 to 48 weeks, or 32 to 48 weeks, wherein the second calorie-restricted diet provides protein per 1 kg of target body weight. Containing 0.8 to 1.6g, or 0.8 to 1.2g, or 1.0g,
A digital therapeutic device for treating overweight or obesity.
According to clause 9,
The management server connects one or more user devices or user terminals owned by one or more users through an information and communication network,
A digital therapeutic device for treating overweight or obesity.
(a) the user entering body information and dietary intake information;
(b) receiving information entered by the user and calculating a target weight or obesity level from the received information;
(c) providing a first calorie-restricted diet to the user for weight loss based on the calculated target weight or obesity level of the user;
(d) inputting whether the user has implemented the first calorie-restricted diet provided and body information that has changed at the time of the user's input;
(e) determining whether the target weight or obesity level has been achieved based on the user's changed body information;
(f) providing expert coaching, consultation, or management to maintain the user's weight loss or obesity reduction according to the results of the step of determining whether the target weight or obesity level has been achieved; and
(g) additionally providing a second calorie-restricted diet to the user according to the results of determining whether the target weight or obesity level has been achieved,
The first calorie-restricted diet is provided as a calorie-restricted alternative meal of 180 to 220 kcal for one to three of the three regular meals each day, and a total calorie-restricted diet of 1000 to 1200 Kcal or 600 to 800 Kcal per day. provided for 1 week to 16 weeks, 2 weeks to 12 weeks, or 2 weeks to 8 weeks, wherein the first calorie-restricted diet contains 1.0 to 2.0 g of protein per kg of set target body weight, or 1.2 to 1.6 g, or Contains 1.5g,
The second calorie-restricted diet is provided as a calorie-restricted replacement for 180 to 220 Kcal of the regular diet for one to two meals a day for 1 to 2 weeks every month, with a total of 1200 to 1500 Kcal or 1500 to 1800 Kcal per day. A restricted diet is provided for 4 to 48 weeks, 24 to 48 weeks, or 32 to 48 weeks, and the second calorie-restricted diet contains 0.8 to 1.6 g of protein per kg of set target body weight, or 0.8 to 0.8 to 1.6 g of protein per kg of body weight. Containing 1.2g, or 1.0g,
A method of managing overweight or obesity performed via a computing device or mobile electronic device.
According to clause 13,
In the step (e) of determining whether the target weight or obesity level has been achieved based on the changed body information of the user, if it is determined that the target weight or obesity level has not been achieved, the first calorie-restricted diet is provided to the user. Returning to step (C) and performing steps (C) and (d) one, two, three or more additional times to provide again,
A method of managing overweight or obesity performed via a computing device or mobile electronic device.
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