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Evaluation of Planetary Health Diet Recommendation Using Mobile Application in Adults

Primary Purpose

Health Behavior, Overweight and Obesity, Eating Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Counseling on planetary health diet with calorie restriction
Counseling on balanced nutrition diet with calorie restriction
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health Behavior focused on measuring Sustainable diet, Adult, Overweight, Obese, Mobile application, Planetary Health Diet

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 19 - 60 years old Female/male Domiciled in DKI Jakarta Body Mass Index of more than 23 Having android mobile phone and internet connection Having time to participate in the research Consists of ordinary adults and health professionals aged 19-65 years in DKI Jakarta Exclusion Criteria: Illiterate Breastfeeding mother Pregnant women Undergoing specific diet program Undergoing specific medications related to body weight Consuming drugs Planning to move residence during the 6 months of the study period Not willing to sign informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    90 overweight/obese adults will be given counseling on planetary health diet, calorie restriction diet, and healthy lifestyle materials through a mobile app within 6 months

    90 overweight/obese adults will be given counseling on balanced nutrition diet, calorie restriction diet, and healthy lifestyle materials through a mobile app within 6 months

    Outcomes

    Primary Outcome Measures

    Body Mass Index (BMI)
    change in Body Mass Index (BMI) obtained from anthropometric measurements (weight (kilograms) and height (meters) converted to Body Mass Index (BMI) score)
    Waist circumference
    Change in waist circumference obtained from anthropometric measurements.
    Systolic blood pressure
    change in systolic and diastolic blood pressure obtained from blood pressure measurements using calibrated Sphygmomanometer.
    Diastolic blood preassure
    Change in diastolic blood pressure obtained from blood pressure measurements using calibrated sphygmomanometer
    Diet Quality
    change in diet quality score assessed by Healthy Eating Index (HEI) 2015 scoring system using multiple 24-hour food recall data. The HEI-2015 contains 13 components that sum to a total maximum score of 100 points, the total HEI score is the sum of the adequacy components and moderation components. The closer a set of foods aligns with the Dietary Guidelines for Americans, the higher the HEI score.
    Green house gas emissions (GHGE)
    change in GHGE score using multiple 24-hour recall data converted to GHGE conversion factor in kilogram of carbon dioxide equivalent per kilogram

    Secondary Outcome Measures

    Physical activity
    Change in physical activity score assessed using The International Physical Activity Questionnaire (IPAQ). The scoring system has three criteria: insufficiently active, minimally Active, and HEPA active.
    Sleep quality
    Change in sleep quality score assessed using The Pittsburgh Sleep Quality Index (PSQI) questionnaire. The sum of the global PSQI scores ranged from 0 to 21. If Global PSQI score was 5 or less (≤5), considered as good sleep quality, if Global PSQI score was more than 5 (>5), considered as poor sleep quality.
    Sel-efficacy
    Change in self-efficacy score (nutrition and physical exercise) assessed using the Berlin Risk Appraisal and Health Motivation questionnaire. In each question, the item wording is provided for the three measures. Response format is (1) very uncertain, (2) rather uncertain, (3) rather certain, and (4) very certain. Each response represents points that will be summed up at the end of the question. The bigger the final score, the better the subject's self-efficacy regarding nutrition and physical exercise is.

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    April 25, 2023
    Sponsor
    Indonesia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05832203
    Brief Title
    Evaluation of Planetary Health Diet Recommendation Using Mobile Application in Adults
    Official Title
    Validation and Effect of the Eats-Up 3.0 Mobile Application With Features of a Balanced and Sustainable Nutrition Diet Recommendation, Healthy Lifestyle, Assessment of Diet Quality and Greenhouse Gas Emission in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indonesia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In recent years, the planetary health diet proposed by the EAT-Lancet Commission has underscored the importance of massive changes to healthy eating on a global scale to prevent environmental degradation. Diet management helps individuals control their food consumption, and this can be supported by the availability of technology through mobile applications. The use of mobile applications considers several aspects such as convenience, comfort, and self-management efficiency in maintaining food consumption. By using an application with the latest features related to diet management, which is equipped with dietary education features, gas emissions, and calculating environmental impacts, it allows users to increase self-awareness to reduce gas emissions from food consumption. Therefore, developing recommendations for a balanced nutritional diet, healthy lifestyle, calculating diet quality, and greenhouse gas emission in one application that is presented in one easy step is an important point in providing comprehensive information for a wider range of potential users. The main objective of this study is to assess the differences in changes in body weight, BMI, waist circumference, and systolic and diastolic blood pressure between the group that was given education on a planetary health diet with calorie restriction and a healthy lifestyle and the group that received education on a balanced diet with calorie restriction and a healthy lifestyle in adults using the 3rd generation of EatsUp mobile application. We will conduct a 24-week intervention for overweight and obese adults.
    Detailed Description
    The EAT-Lancet Commission has proposed a planetary health diet that will improve health, by reducing the burden of non-communicable diseases (NCDs) and will reduce Greenhouse Gas Emissions (GHGE) from food production and consumption globally by up to 80%. The global burden of non-communicable diseases is expected to worsen and the effects of food production on greenhouse gas emissions, nitrogen and phosphorus pollution, loss of biodiversity, and water and land use will reduce the stability of the Earth system. The global food system contributes 19-29% to global greenhouse gas emissions (GHGE) and according to Behrens et al. (2017), the average Indonesian diet produces GHGE of 1.6 KgCO2eq per day. Indonesia, with the characteristics of food consumption depending on the staple food (rice), a slight increase in meat consumption, and the occurrence of obesity in the population of the rich and poor population, shows the early stages of a diet transition. The diet transition effect in developed countries has resulted in an increase in the prevalence of obesity in NCDs, while in developing countries it has caused a double burden of malnutrition. A healthy diet has an appropriate caloric intake and consists of a variety of plant foods, low amounts of animal-sourced foods, unsaturated rather than saturated fats, and small amounts of refined grains, highly processed foods, and added sugars. This study is a randomized clinical trial (RCT) study for overweight and obese adults. The research will be conducted in DKI Jakarta and will consist of 4 (four) stages; screening, recruitment (baseline), providing education, and final data collection (end-line). To find out changes in the provision of education, data will be collected at the beginning of the month and the 6th month (end of the study).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Behavior, Overweight and Obesity, Eating Behavior, Calorie Overload
    Keywords
    Sustainable diet, Adult, Overweight, Obese, Mobile application, Planetary Health Diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    90 overweight/obese adults will be given counseling on planetary health diet, calorie restriction diet, and healthy lifestyle materials through a mobile app within 6 months
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    90 overweight/obese adults will be given counseling on balanced nutrition diet, calorie restriction diet, and healthy lifestyle materials through a mobile app within 6 months
    Intervention Type
    Other
    Intervention Name(s)
    Counseling on planetary health diet with calorie restriction
    Intervention Description
    Counselling on planetary healthy diet, calorie restriction diet, and healthy lifestyle through mobile application
    Intervention Type
    Other
    Intervention Name(s)
    Counseling on balanced nutrition diet with calorie restriction
    Intervention Description
    Counselling on balanced nutrition diet, calorie restriction diet, and healthy lifestyle materials through mobile app
    Primary Outcome Measure Information:
    Title
    Body Mass Index (BMI)
    Description
    change in Body Mass Index (BMI) obtained from anthropometric measurements (weight (kilograms) and height (meters) converted to Body Mass Index (BMI) score)
    Time Frame
    9, 17, and 24 weeks
    Title
    Waist circumference
    Description
    Change in waist circumference obtained from anthropometric measurements.
    Time Frame
    9, 17, and 24 weeks
    Title
    Systolic blood pressure
    Description
    change in systolic and diastolic blood pressure obtained from blood pressure measurements using calibrated Sphygmomanometer.
    Time Frame
    9, 17, 24 weeks
    Title
    Diastolic blood preassure
    Description
    Change in diastolic blood pressure obtained from blood pressure measurements using calibrated sphygmomanometer
    Time Frame
    9, 17, 24 weeks
    Title
    Diet Quality
    Description
    change in diet quality score assessed by Healthy Eating Index (HEI) 2015 scoring system using multiple 24-hour food recall data. The HEI-2015 contains 13 components that sum to a total maximum score of 100 points, the total HEI score is the sum of the adequacy components and moderation components. The closer a set of foods aligns with the Dietary Guidelines for Americans, the higher the HEI score.
    Time Frame
    9, 17, and 24 weeks
    Title
    Green house gas emissions (GHGE)
    Description
    change in GHGE score using multiple 24-hour recall data converted to GHGE conversion factor in kilogram of carbon dioxide equivalent per kilogram
    Time Frame
    9, 17, and 24 weeks
    Secondary Outcome Measure Information:
    Title
    Physical activity
    Description
    Change in physical activity score assessed using The International Physical Activity Questionnaire (IPAQ). The scoring system has three criteria: insufficiently active, minimally Active, and HEPA active.
    Time Frame
    9, 17, and 24 weeks
    Title
    Sleep quality
    Description
    Change in sleep quality score assessed using The Pittsburgh Sleep Quality Index (PSQI) questionnaire. The sum of the global PSQI scores ranged from 0 to 21. If Global PSQI score was 5 or less (≤5), considered as good sleep quality, if Global PSQI score was more than 5 (>5), considered as poor sleep quality.
    Time Frame
    9, 17, and 24 weeks
    Title
    Sel-efficacy
    Description
    Change in self-efficacy score (nutrition and physical exercise) assessed using the Berlin Risk Appraisal and Health Motivation questionnaire. In each question, the item wording is provided for the three measures. Response format is (1) very uncertain, (2) rather uncertain, (3) rather certain, and (4) very certain. Each response represents points that will be summed up at the end of the question. The bigger the final score, the better the subject's self-efficacy regarding nutrition and physical exercise is.
    Time Frame
    9, 17, and 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 19 - 60 years old Female/male Domiciled in DKI Jakarta Body Mass Index of more than 23 Having android mobile phone and internet connection Having time to participate in the research Consists of ordinary adults and health professionals aged 19-65 years in DKI Jakarta Exclusion Criteria: Illiterate Breastfeeding mother Pregnant women Undergoing specific diet program Undergoing specific medications related to body weight Consuming drugs Planning to move residence during the 6 months of the study period Not willing to sign informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rina Agustina, PhD
    Phone
    +622129189160
    Ext
    201052
    Email
    r.agustina@ui.ac.id
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rahyussalim Rahyussalim, PhD
    Phone
    +622129189160
    Ext
    201908
    Email
    manajer.riset.fkui1@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rina AS Agustina, PhD
    Organizational Affiliation
    Human Nutrition Research Center, IMERI; Dep of Nutrition, Fac.of Medicine UI
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Links:
    URL
    https://kesmas.kemkes.go.id/konten/144/0/tumpeng-gizi-seimbang-dan-10-pesan-giziseimbang
    Description
    Tumpeng Gizi Seimbang Kementrian Kesehatan Indonesia
    URL
    http://p2ptm.kemkes.go.id/infographic-p2ptm/obesitas/isi-piringku-sekali-makan
    Description
    Isi piringku sekali makan, Direktorat P2PTM

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