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AzTrials

Health BehaviorNCT05832203

Evaluation of Planetary Health Diet Recommendation Using Mobile Application in Adults

A study testing Counseling on planetary health diet with calorie restriction and Counseling on balanced nutrition diet with calorie restriction in people with Health Behavior and Overweight and Obesity, run by Universitas Indonesia at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 60 yearsHealthy volunteers can take part
What is being tested?
Counseling on planetary health diet with calorie restriction and Counseling on balanced nutrition diet with calorie restriction
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
1 siteIndonesia
Study dates
1 May 2023to 30 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Department of Nutrition (FKUI-RSCM); and Human Nutrition Research Center, Indonesian Medical Education Research Institute (HNRC-IMERI) Faculty of Medicine, Universitas Indonesia

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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

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.

Read the 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).

Being tested
Counseling on planetary health diet with calorie restriction, Counseling on balanced nutrition diet with calorie restriction
Keywords
Sustainable diet, Adult, Overweight, Obese, Mobile application, Planetary Health Diet
Medical subject headings
Health Behavior, Overweight, Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counseling on planetary health diet with calorie restrictionOther

    Counselling on planetary healthy diet, calorie restriction diet, and healthy lifestyle through mobile application

  • Counseling on balanced nutrition diet with calorie restrictionOther

    Counselling on balanced nutrition diet, calorie restriction diet, and healthy lifestyle materials through mobile app

Study groups in NCT05832203
Study groupRoleWhat they receive
InterventionExperimental90 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
Receives: Other: Counseling on planetary health diet with calorie restriction
ControlPlacebo comparator90 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
Receives: Other: Counseling on balanced nutrition diet with calorie restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 9, 17, and 24 weeks

  2. Waist circumference

    Change in waist circumference obtained from anthropometric measurements.

    Measured: 9, 17, and 24 weeks

  3. Systolic blood pressure

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

    Measured: 9, 17, 24 weeks

  4. Diastolic blood preassure

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

    Measured: 9, 17, 24 weeks

  5. 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.

    Measured: 9, 17, and 24 weeks

  6. 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

    Measured: 9, 17, and 24 weeks

Secondary outcomes (3)
  1. 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.

    Measured: 9, 17, and 24 weeks

  2. 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.

    Measured: 9, 17, and 24 weeks

  3. 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.

    Measured: 9, 17, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2023
  2. Study start1 May 2023
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05832203
Sponsor's protocol ID
EARTH
Status last verified
May 2024
First submitted
13 Mar 2023
Last updated
4 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tukker A, Goldbohm RA, de Koning A, Verheijden M, Kleijn R, Wolf O, et al. Environmental impacts of changes to healthier diets in Europe. Ecological Economics. 2011 Aug 15;70(10):1776-88.

  • Behrens P, Kiefte-de Jong JC, Bosker T, Rodrigues JFD, de Koning A, Tukker A. Evaluating the environmental impacts of dietary recommendations. Proc Natl Acad Sci U S A. 2017 Dec 19;114(51):13412-13417. doi: 10.1073/pnas.1711889114. Epub 2017 Dec 4.

    PubMed 29203655
  • Popkin BM, Adair LS, Ng SW. Global nutrition transition and the pandemic of obesity in developing countries. Nutr Rev. 2012 Jan;70(1):3-21. doi: 10.1111/j.1753-4887.2011.00456.x.

    PubMed 22221213
  • de Pee S, Hardinsyah R, Jalal F, Kim BF, Semba RD, Deptford A, Fanzo JC, Ramsing R, Nachman KE, McKenzie S, Bloem MW. Balancing a sustained pursuit of nutrition, health, affordability and climate goals: exploring the case of Indonesia. Am J Clin Nutr. 2021 Nov 8;114(5):1686-1697. doi: 10.1093/ajcn/nqab258.

    PubMed 34477830
  • Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.

    PubMed 30660336
  • Abdurahman AA, Bule M, Azadbakhat L, Fallahyekta M, Parouhan A, Qorbani M, Dorosty AR. The association between diet quality and obesity-related metabolic risks. Hum Antibodies. 2020;28(1):1-9. doi: 10.3233/HAB-190387.

    PubMed 31282409
  • Masset G, Soler LG, Vieux F, Darmon N. Identifying sustainable foods: the relationship between environmental impact, nutritional quality, and prices of foods representative of the French diet. J Acad Nutr Diet. 2014 Jun;114(6):862-869. doi: 10.1016/j.jand.2014.02.002. Epub 2014 Apr 4.

    PubMed 24703928
  • Stefani S, Ngatidjan S, Paotiana M, Sitompul KA, Abdullah M, Sulistianingsih DP, Shankar AH, Agustina R. Dietary quality of predominantly traditional diets is associated with blood glucose profiles, but not with total fecal Bifidobacterium in Indonesian women. PLoS One. 2018 Dec 21;13(12):e0208815. doi: 10.1371/journal.pone.0208815. eCollection 2018.

    PubMed 30576336
  • Siregar DAS, Rianda D, Irwinda R, Dwi Utami A, Hanifa H, Shankar AH, Agustina R. Associations between diet quality, blood pressure, and glucose levels among pregnant women in the Asian megacity of Jakarta. PLoS One. 2020 Nov 25;15(11):e0242150. doi: 10.1371/journal.pone.0242150. eCollection 2020.

    PubMed 33237938
  • van de Kamp ME, van Dooren C, Hollander A, Geurts M, Brink EJ, van Rossum C, Biesbroek S, de Valk E, Toxopeus IB, Temme EHM. Healthy diets with reduced environmental impact? - The greenhouse gas emissions of various diets adhering to the Dutch food based dietary guidelines. Food Res Int. 2018 Feb;104:14-24. doi: 10.1016/j.foodres.2017.06.006. Epub 2017 Jun 6.

    PubMed 29433779
  • Ahn JS, Kim DW, Kim J, Park H, Lee JE. Development of a Smartphone Application for Dietary Self-Monitoring. Front Nutr. 2019 Sep 23;6:149. doi: 10.3389/fnut.2019.00149. eCollection 2019.

    PubMed 31608283
  • Choi J, Chung C, Woo H. Diet-Related Mobile Apps to Promote Healthy Eating and Proper Nutrition: A Content Analysis and Quality Assessment. Int J Environ Res Public Health. 2021 Mar 28;18(7):3496. doi: 10.3390/ijerph18073496.

    PubMed 33800531
  • Krebs-Smith SM, Pannucci TE, Subar AF, Kirkpatrick SI, Lerman JL, Tooze JA, Wilson MM, Reedy J. Update of the Healthy Eating Index: HEI-2015. J Acad Nutr Diet. 2018 Sep;118(9):1591-1602. doi: 10.1016/j.jand.2018.05.021.

    PubMed 30146071
  • Rahmi RN, Poolsawad N, Sranacharoenpong K. Environmental Impacts Related to Food Consumption of Indonesian Adults. J Nutr Sci Vitaminol (Tokyo). 2020;66(Supplement):S149-S154. doi: 10.3177/jnsv.66.S149.

    PubMed 33612585
  • David SK, Rafiullah MR. Innovative health informatics as an effective modern strategy in diabetes management: a critical review. Int J Clin Pract. 2016 Jun;70(6):434-49. doi: 10.1111/ijcp.12816.

    PubMed 27238962

Questions about this trial

What is this clinical trial studying?

A study testing Counseling on planetary health diet with calorie restriction and Counseling on balanced nutrition diet with calorie restriction in people with Health Behavior and Overweight and Obesity, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: 9, 17, and 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05832203, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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