Evaluation of Planetary Health Diet Recommendation Using Mobile Application in Adults

Sponsor
Indonesia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05832203
Collaborator
(none)
180
2
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Counseling on planetary health diet with calorie restriction
  • Other: Counseling on balanced nutrition diet with calorie restriction
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Other: Counseling on planetary health diet with calorie restriction
Counselling on planetary healthy diet, calorie restriction diet, and healthy lifestyle through mobile application

Placebo Comparator: Control

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

Other: Counseling on balanced nutrition diet with calorie restriction
Counselling on balanced nutrition diet, calorie restriction diet, and healthy lifestyle materials through mobile app

Outcome Measures

Primary Outcome Measures

  1. Body Mass Index (BMI) [9, 17, and 24 weeks]

    change in Body Mass Index (BMI) obtained from anthropometric measurements (weight (kilograms) and height (meters) converted to Body Mass Index (BMI) score)

  2. Waist circumference [9, 17, and 24 weeks]

    Change in waist circumference obtained from anthropometric measurements.

  3. Systolic blood pressure [9, 17, 24 weeks]

    change in systolic and diastolic blood pressure obtained from blood pressure measurements using calibrated Sphygmomanometer.

  4. Diastolic blood preassure [9, 17, 24 weeks]

    Change in diastolic blood pressure obtained from blood pressure measurements using calibrated sphygmomanometer

  5. Diet Quality [9, 17, and 24 weeks]

    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.

  6. Green house gas emissions (GHGE) [9, 17, and 24 weeks]

    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

  1. Physical activity [9, 17, and 24 weeks]

    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.

  2. Sleep quality [9, 17, and 24 weeks]

    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.

  3. Sel-efficacy [9, 17, and 24 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Rina AS Agustina, PhD, Human Nutrition Research Center, IMERI; Dep of Nutrition, Fac.of Medicine UI

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rina Agustina, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT05832203
Other Study ID Numbers:
  • EARTH
First Posted:
Apr 27, 2023
Last Update Posted:
Apr 27, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rina Agustina, Principal Investigator, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023