Overweight and Obesity Clinical Trial
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
Verified date | May 2024 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | November 30, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | 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 |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 9, 17, and 24 weeks | |
Primary | Waist circumference | Change in waist circumference obtained from anthropometric measurements. | 9, 17, and 24 weeks | |
Primary | Systolic blood pressure | change in systolic and diastolic blood pressure obtained from blood pressure measurements using calibrated Sphygmomanometer. | 9, 17, 24 weeks | |
Primary | Diastolic blood preassure | Change in diastolic blood pressure obtained from blood pressure measurements using calibrated sphygmomanometer | 9, 17, 24 weeks | |
Primary | 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. | 9, 17, and 24 weeks | |
Primary | 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 | 9, 17, and 24 weeks | |
Secondary | 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. | 9, 17, and 24 weeks | |
Secondary | 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. | 9, 17, and 24 weeks | |
Secondary | 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. | 9, 17, and 24 weeks |
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