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临床试验/NCT05832203
NCT05832203进行中(未招募)不适用

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

Indonesia University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
1
主要终点
Body Mass Index (BMI)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intervention

Experimental

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

干预措施: Counseling on planetary health diet with calorie restriction (Other)

Control

Placebo Comparator

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

干预措施: Counseling on balanced nutrition diet with calorie restriction (Other)

结局指标

主要结局

Body Mass Index (BMI)

时间窗: 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)

Systolic blood pressure

时间窗: 9, 17, 24 weeks

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

Diet Quality

时间窗: 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.

Waist circumference

时间窗: 9, 17, and 24 weeks

Change in waist circumference obtained from anthropometric measurements.

Diastolic blood preassure

时间窗: 9, 17, 24 weeks

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

Green house gas emissions (GHGE)

时间窗: 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

次要结局

  • Physical activity(9, 17, and 24 weeks)
  • Sleep quality(9, 17, and 24 weeks)
  • Sel-efficacy(9, 17, and 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Rina Agustina, MD, PhD

Principal Investigator

Indonesia University

研究点 (1)

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