NCT03469869

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 27, 2018

Last Update Submit

February 22, 2019

Conditions

ObesityInsulin ResistanceInflammationBlood Glucose, High

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change of body weight

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

    baseline at Day0 and endline at Day56

Secondary Outcomes (9)

  • 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 TNF alpha

    baseline at Day0 and endline at Day56

  • Change of Fasting Insulin

    baseline at Day0 and endline at Day56

  • Change of HOMA-IR

    baseline at Day0 and endline at Day56

  • +4 more secondary outcomes

Study Arms (2)

balanced and sustainable diet

EXPERIMENTAL

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

balanced diet

ACTIVE COMPARATOR

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

Interventions

balanced and sustainable dietOTHER

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.

balanced and sustainable dietbalanced diet

Eligibility Criteria

Age19 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥ 25 kg/m2
  • using Android-based smartphone
  • willing to join this research by signing informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Indonesia

Depok, West Java, 16424, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 35725407DERIVED

MeSH Terms

Conditions

ObesityInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Study Officials

  • Rina Agustina, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group balance diet One group balance and sustainable diet
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Human Nutrition Research Center

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 19, 2018

Study Start

March 16, 2018

Primary Completion

June 30, 2018

Study Completion

October 31, 2018

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

ID(1)