Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia

Conditions
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Obesity, Insulin Resistance, Inflammation, Blood Glucose, High

Intervention / Treatment
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* Other: balanced and sustainable diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group balance diet One group balance and sustainable diet
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balanced and sustainable diet<br>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 | Other: balanced and sustainable diet<br>* the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp. the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.<br>|
| Active Comparator: balanced diet<br>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 | Other: balanced and sustainable diet<br>* the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp. the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body weight | Change from baseline body weight at 8 weeks, is measured in kg | baseline at Day0 and endline at Day56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fat Mass | Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg | baseline at Day0 and endline at Day56 | 
| Change of Fasting plasma glucose | Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL | baseline at Day0 and endline at Day56 | 
| Change of TNF alpha | Change from baseline TNF alpha at 8 weeks, is measured in pg/ml | baseline at Day0 and endline at Day56 | 
| Change of Fasting Insulin | Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL | baseline at Day0 and endline at Day56 | 
| Change of HOMA-IR | Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405 | baseline at Day0 and endline at Day56 | 
| Change of Waist Circumference | Change from baseline Waist Circumference at 8 weeks, is measured in cm | baseline at Day0 and endline at Day56 | 
| Change of Carbohydrate intake | Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall | baseline at Day0 and endline at Day56 | 
| Change of Fat intake | Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall | baseline at Day0 and endline at Day56 | 
| Change of Protein intake | Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall | baseline at Day0 and endline at Day56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity