The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of body weight
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 19 Years to 59 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body mass index ≥ 25 kg/m2
- •using Android-based smartphone
- •willing to join this research by signing informed consent
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: 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
Intervention: balanced and sustainable diet (Other)
Outcomes
Primary Outcomes
Change of body weight
Time Frame: baseline at Day0 and endline at Day56
Change from baseline body weight at 8 weeks, is measured in kg
Secondary Outcomes
- 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)
Investigators
Rina Agustina
Head of Human Nutrition Research Center
Indonesia University