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Study on the effect of mobile application dietary management on the metabolic profile

Status Approved

  • First Submitted Date

    2019/07/23

  • Registered Date

    2019/08/21

  • Last Updated Date

    2023/11/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004226
    Unique Protocol ID 1903/003-013
    Public/Brief Title Study on the effect of mobile application dietary management on the metabolic profile
    Scientific Title Study on the effect of mobile application dietary management on the metabolic profile
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1903/003-013
    Approval Date 2019-07-05
    Institutional Review Board Name Institutional Review Board of Seoul National University
    Institutional Review Board Address 1, Gwanak-ro, Gwanak-gu, Seoul
    Institutional Review Board Telephone 02-880-5153
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jung Eun Lee
    Title Professor
    Telephone +82-2-880-6834
    Affiliation Seoul National University
    Address 1, Gwanak-ro, Gwanak-gu, Seoul
    Contact Person for Public Queries
    Name Taiyue Jin
    Title Master
    Telephone +82-2-880-8753
    Affiliation Seoul National University
    Address 1, Gwanak-ro, Gwanak-gu, Seoul
    Contact Person for Updating Information
    Name Taiyue Jin
    Title Master
    Telephone +82-2-880-8753
    Affiliation Seoul National University
    Address 1, Gwanak-ro, Gwanak-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-07-11 Actual
    Target Number of Participant 60
    Primary Completion Date 2019-12-31 , Actual
    Study Completion Date 2020-12-31 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul National University
    Recruitment Status Completed
    Date of First Enrollment 2019-07-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Science and ICT
    Organization Type Government
    Project ID 2014-1-00720
    2. Source of Monetary/Material Support
    Organization Name Ministry of Science and ICT
    Organization Type Government
    Project ID 2019H1C3A1032224
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    1. Purpose of Study
    
    ○ Analysis of food management effects of the food management application
    ○ Analysis of weight loss effects of food management application
    ○ Identify the effects of food management application on blood metabolites
    
    2. Research Background
    
    ○ According to the 2016 Community Health Survey conducted by the Korea Centers for Disease Control and Prevention, the health life of local residents related to the occurrence of major chronic diseases such as cancer, cardiovascular disease and chronic obstructive pulmonary disease has not been improved overall. In particular, the rate of attempted weight control has been increasing since 2008, while the rate of obesity has been steadily increasing.
    
    ○ The World Health Organization (WHO) has identified unhealthy diets, smoking, and lack of exercise as major risk factors for chronic diseases such as heart disease, stroke, cancer, chronic lung disease, and diabetes. More specifically, it is recommended that specific dietary patterns, such as increased food intake, can increase the risk of chronic disease and therefore follow detailed Dietary Guidelines by specifying detailed dietary factors such as high salt intake and trans-fat intake. Healthy eating habits and exercise alone can greatly reduce the risk of developing diabetes.
    
    ○ Intervention studies have been actively conducted to change the dietary habits and exercise behaviors of research participants using smartphone applications. Most of them include goal setting, action input and monitoring, and immediate feedback function. Through the monitoring function, the participant enters his or her usual eating behavior and automatically analyzes the nutritional data within the system, so that the researcher can more easily investigate the information on the nutritional intake.
    
    ○ 51 students who were overweight or obese (BMI≥24 kg/㎡), aged 18-35, were randomly assigned to one of two experimental groups: one to control weight using an application and the other to control daily weight. The average BMI of the application-use group was reduced by 1.6±2.6 kg/㎡, but no significant difference was found in the control group.
    
    ○ Metabolomics is one of the fields of biology that analyzes metabolism of cells and tissues and studies metabolic circuits accordingly. Metabolites are substances that are produced in processes such as energy production and storage, signal transduction, etc. of cells. In addition to being produced directly by host organisms, metabolites may be derived from microorganisms, foreign matter, dietary and other exogenous sources.
    
    ○ A total of 91 obese adults underwent a 1-year non-surgical weight loss program and analyzed the difference in serum metabolites from 137 before and after weight loss. The mean BMI of the subjects was decreased from 42.7±5.8kg/㎡ to 36.3±6.6kg/㎡ and about 58 kinds of metabolites were different before and after weight loss. Among them, amino acids associated with the onset of type 2 diabetes, such as isoleucine, leucine, valine, and tyrosine, were found to show differences between before and after weight loss.
    
    3. Outline of research method
    
       This study will analyze the food and nutrient intake of each person and group through the diet record entered by the user using the food management application "Noom Coach" or the diet record notes, and compare the application group with the diet record note group to evaluate the effect of eating habits and weight loss. We will also analyze changes in blood metabolites before and after weight loss in the use of application and diet record note.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description
    Sixty obese adults (BMI 25 kg/㎡ or more) with a willingness to weight loss were randomly assigned to the experimental group using the food management application and the control group using the diet record notes. The experimental group used the food management application "Noom Coach" and the control group used the diet record notes to record their meals freely for 3 months. Considering the possibility that the target energy intake setting function of the food management application significantly increases the participation intention of the experimental group, the control group before the start of the study is also provided with the dietary management leaflet to calculate the energy requirement for each participants and set the target energy intake box.
    Number of Arms 2
    Arm 1

    Arm Label

    Food management application group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    Of the sixty obese adults (BMI 25 kg/㎡ or more), 30 participants assigned to the experimental group through the stratified randomization method will record their meals for 3 months using the food management application "Noom Coach". Application "Noom Coach" has automatic calculation of calorie and nutrients during meal recording.
    Arm 2

    Arm Label

    diet record note group

    Target Number of Participant

    30

    Arm Type

    Active comparator

    Arm Description

    Of the sixty obese adults (BMI 25 kg/㎡ or more), 30 participants assigned to the control group through the stratified randomization method will recorded their meals for 3 months using the diet record notes. Participants should calculate the daily total calorie intake by using Ministry of Food and Drug Safety's Food Safety Agency or Rural Development Administration agro-food comprehensive information system when recording food. It is expected that the increases of the participation intention among the food management application group due to the target calorie intake setting function of “Noom Coach”, the researcher will calculate the target calorie intake and report it to diet record note group.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 

    Obese adults with a BMI of over 25 kg/㎡
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~50Year

    Description

    18~50 years old obese Korean or foreigner adluts (BMI 25 kg/㎡ or more) who are willing to weight loss and can use smartphone
    Exclusion Criteria
    1. Do not use smartphone
    2. Persons who are not interviewed due to serious illness
    3. BMI less than 25kg/㎡
    4. Those who are not 18 to 50 years old
    5. Anyone who has been using the food management application or diet record notes during the last month
    6. Persons who were currently taking diet pills or have experienced weight-loss surgery
    7. Persons who is currently taking medication
    8. Menopause or irregular menstrual cycle
    9. Current pregnant or breastfeeding
    10. People who are suffering from chronic diseases or obesity-induced diseases or who are currently being treated (diabetes, hypertension, hyperlipidemia, cerebrovascular disease, cardiovascular disease, thyroid disease, polycystic ovary syndrome, various cancers, etc.)
    11. Persons who were diagnosed with diabetes or dyslipidemia (blood glucose level ≥126 mg/dL (7.0 mmol/L) in diabetes mellitus, blood lipid levels in total blood cholesterol >240 mg/dL or low density lipoprotein Cholesterol ≥160 mg/dL or triglyceride ≥200 mg/dL or high-density lipoprotein cholesterol <40 mg/dL)
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Weight, Body Mass Index, Fat Mass, Waist Circumference, Blood Metabolite type and amount
    Timepoint
    Before the study, after the study
    Secondary Outcome(s) 1
    Outcome
    Dietary habits, Daily energy intake, Daily nutrient intake
    Timepoint
    Before the study, after the study
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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