The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change of body weight
研究概览
简要总结
This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.
Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only
详细描述
Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.
The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.
The main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.
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)
盲法说明
Giving a spesific personal menu through android apps, one group with balance diet menu, and the other with balance and sustainable diet menu. Only di IT knows which person get which type of menu
入排标准
- 年龄范围
- 19 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥ 25 kg/m2
- •using Android-based smartphone
- •willing to join this research by signing informed consent
排除标准
- •pale in physical examination
- •in weight loss program
- •have obesity with comorbidities
- •have hormonal diseases
- •consumed hormonal drug, PTU, anti diabetes drug
- •smoking or stop smoking under 2 years
- •pregnant and breastfeeding women
研究组 & 干预措施
balanced and sustainable diet
The intervention group will receive menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the control group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps
干预措施: balanced and sustainable diet (Other)
balanced diet
the intervention group receive get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will receive menu recommendation of balanced diet for 8 weeks. these menus are given in the apps
干预措施: balanced and sustainable diet (Other)
结局指标
主要结局
Change of body weight
时间窗: baseline at Day0 and endline at Day56
Change from baseline body weight at 8 weeks, is measured in kg
次要结局
- Change of Fat Mass(baseline at Day0 and endline at Day56)
- Change of Fasting plasma glucose(baseline at Day0 and endline at Day56)
- Change of HOMA-IR(baseline at Day0 and endline at Day56)
- Change of Carbohydrate intake(baseline at Day0 and endline at Day56)
- Change of TNF alpha(baseline at Day0 and endline at Day56)
- Change of Fasting Insulin(baseline at Day0 and endline at Day56)
- Change of Waist Circumference(baseline at Day0 and endline at Day56)
- Change of Protein intake(baseline at Day0 and endline at Day56)
- Change of Fat intake(baseline at Day0 and endline at Day56)
研究者
Rina Agustina
Head of Human Nutrition Research Center
Indonesia University