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

Primary Purpose

Obesity, Insulin Resistance, Inflammation

Status

Completed

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

balanced and sustainable diet

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity

Eligibility Criteria

19 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

University of Indonesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

balanced and sustainable diet

balanced diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of body weight

Change from baseline body weight at 8 weeks, is measured in kg

Secondary Outcome Measures

Change of Fat Mass

Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg

Change of Fasting plasma glucose

Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL

Change of TNF alpha

Change from baseline TNF alpha at 8 weeks, is measured in pg/ml

Change of Fasting Insulin

Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL

Change of HOMA-IR

Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405

Change of Waist Circumference

Change from baseline Waist Circumference at 8 weeks, is measured in cm

Change of Carbohydrate intake

Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall

Change of Fat intake

Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall

Change of Protein intake

Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall

Full Information

NCT ID

NCT03469869

First Posted

February 27, 2018

Last Updated

February 22, 2019

Sponsor

Indonesia University

Collaborators

Fakultas Kedokteran Universitas Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT03469869

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 16, 2018 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indonesia University

Collaborators

Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Insulin Resistance, Inflammation, Blood Glucose, High

Keywords

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

One group balance diet One group balance and sustainable diet

Masking

ParticipantCare ProviderInvestigatorOutcomes 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

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

balanced and sustainable diet

Arm Type

Experimental

Arm Description

Arm Title

balanced diet

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

balanced and sustainable diet

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of body weight

Description

Change from baseline body weight at 8 weeks, is measured in kg

Time Frame

baseline at Day0 and endline at Day56

Secondary Outcome Measure Information:

Title

Change of Fat Mass

Description

Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Fasting plasma glucose

Description

Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL

Time Frame

baseline at Day0 and endline at Day56

Title

Change of TNF alpha

Description

Change from baseline TNF alpha at 8 weeks, is measured in pg/ml

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Fasting Insulin

Description

Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL

Time Frame

baseline at Day0 and endline at Day56

Title

Change of HOMA-IR

Description

Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Waist Circumference

Description

Change from baseline Waist Circumference at 8 weeks, is measured in cm

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Carbohydrate intake

Description

Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Fat intake

Description

Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall

Time Frame

baseline at Day0 and endline at Day56

Title

Change of Protein intake

Description

Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall

Time Frame

baseline at Day0 and endline at Day56

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rina Agustina, PhD

Organizational Affiliation

Indonesia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Indonesia

City

Depok

State/Province

West Java

ZIP/Postal Code

16424

Country

Indonesia

12. IPD Sharing Statement

Citations:

PubMed Identifier

35725407

Citation

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.

Results Reference

derived

Learn more about this trial

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

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