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

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

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

Study Overview

• Status: Completed
• Conditions: Inflammation; Obesity; Insulin Resistance; Blood Glucose, High
• Intervention / Treatment: Other: balanced and sustainable diet

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Depok, West Java, Indonesia, 16424
      • University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: balanced and sustainable diet; 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.
Active Comparator: 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	Other: balanced and sustainable diet; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Rina Agustina, PhD, Indonesia University

Publications and helpful links

General Publications

• Agustina R, Febriyanti E, Putri M, Martineta M, Hardiany NS, Mustikawati DE, Hanifa H, Shankar AH. Development and preliminary validity of an Indonesian mobile application for a balanced and sustainable diet for obesity management. BMC Public Health. 2022 Jun 20;22(1):1221. doi: 10.1186/s12889-022-13579-x.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Obesity
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Inflammation; Insulin Resistance
• Other Study ID Numbers: YULIA-SAMI project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No