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

Not Applicable

Completed

• Conditions: Insulin Resistance; Blood Glucose, High; Obesity; Inflammation
• Interventions: Other: balanced and sustainable diet

• Registration Number: NCT03469869
• Lead Sponsor: Indonesia University

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 Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-12
• Study Start: 2018-03-16
• Study First Posted: 2018-03-19
• Primary Completion: 2018-06-30
• Study Completion: 2018-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
balanced and sustainable diet	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
balanced diet	balanced and sustainable 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

Primary Outcome Measures

Name	Time	Method
Change of body weight	baseline at Day0 and endline at Day56	Change from baseline body weight at 8 weeks, is measured in kg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Indonesia; 🇮🇩 Depok, West Java, Indonesia