Mindful Eating Intervention Using EATS UP App: Effects on Body Composition and Insulin Resistance in Obese Adolescents

April 15, 2025 updated by: Aryono Hendarto, Indonesia University

Pengembangan Model Mindful Eating Intervention Dengan Aplikasi (EATS UP) Pada Remaja Obes Dan Pengaruhnya Terhadap Komposisi Tubuh Dan Resistensi Insulin (Indonesia Language)

The goal of this experimental study is to develop and evaluate the effectiveness of a Mindful Eating Intervention (MEI) model integrated with the digital application EatsUp for improving body fat percentage among obese adolescents in Indonesia. The study aims to address the rising prevalence of adolescent obesity and its associated health risks, such as insulin resistance and cardiometabolic syndrome, by promoting mindful eating habits and healthy lifestyle behaviors.

The main questions it aims to answer are:

  • Is the MEI model valid and acceptable for use among obese adolescents?

  • Does the MEI model reduce:

    • Body fat percentage?
    • Waist-to-height ratio (WHtR)?
    • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)?
  • Does the MEI model improve eating behavior scores compared to a control group over 12 weeks?

Participants will:

  • Use the EatsUp app, designed to monitor calorie intake/output and deliver mindful eating and nutrition education.
  • Receive training on mindfulness-based eating practices, along with guidance on balanced nutrition and physical activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 15-18 years old
  • Agreed to be involved in research proven by signing informed consent and assent
  • Indicated as Obesity by BMI-Age Nutritional Status and body fat percentage

Exclusion Criteria:

  • Subject is on a dietary treatment or has a serious condition (e.g. chronic infectious disease, and undergoing drug therapy)
  • Subject with special needs (cannot use internet, cannot communicate normally)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition and Physical Activity with Mindful Eating Intervention
The intervention group receiving nutrition and physical activity with mindful eating intervention
Behavioral: Nutrition and Physical Activity Education with Mindful Eating Intervention
Mindful Eating Intervention applied to Obesity treatment for Adolescent alongside with Nutrition and Physical Activity Education from Nutritionist and Psychologist
Experimental: Nutrition and Physical Activity Education
The control group receiving only nutrition and physical activity education
Behavioral: Nutrition and Physical Activity Education
Nutrition and physical activity education from Nutritionist applied as Obesity treatment for Adolescent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition
Time Frame: From enrollment to the end of intervention at 12 weeks
Body composition measured in this study are Body Mass Index for Age (BMI-Age), Waist-to-Height Ratio (WHtR), Waist Circumference, Body Fat Percentage,
From enrollment to the end of intervention at 12 weeks
Fasting Blood Sugar Levels
Time Frame: From enrollment to the end of intervention at 12 weeks
Blood glucose examination is carried out after fasting for 10 - 12 hours.
From enrollment to the end of intervention at 12 weeks
Fasting Insulin Levels
Time Frame: From enrollment to the end of intervention at 12 weeks
Measures the amount of insulin in the blood during fasting.
From enrollment to the end of intervention at 12 weeks
Insulin Resistance
Time Frame: From enrollment to the end of intervention at 12 weeks
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance): Calculated using fasting glucose and insulin levels, with a threshold value (≥3.8) indicating insulin resistance.
From enrollment to the end of intervention at 12 weeks
Eating Behavior
Time Frame: From enrollment to the end of intervention at 12 weeks
Psychosocial factors and attitudes that influence eating behavior such as food choices, dieting, and the presence of eating disorders measured using Adolescent Food Habit Checklist (AFHC)
From enrollment to the end of intervention at 12 weeks
Sleep Quality
Time Frame: From enrollment to the end of intervention at 12 weeks
Sleep can produce a feeling of being fit, assessed based on duration, latency, efficiency and sleep disturbance as measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
From enrollment to the end of intervention at 12 weeks
Physical Activity Level
Time Frame: From enrollment to the end of intervention at 12 weeks
Measurement of physical activity during the last 7 days using the International Physical Activity Questionnaire for Adolescent (IPAQ-A)
From enrollment to the end of intervention at 12 weeks
Mindful Eating Score
Time Frame: From enrollment to the end of intervention at 12 weeks
Mindful eating is assessed based on 5 domains: distraction, disinhibition, awareness, external cues, and emotional eating. Mindful Eating Questionnaire is scored by adding up responses to each item and dividing by the total number of items answered. The resulting score ranges from 1 to 4, with higher scores indicating more mindful eating.
From enrollment to the end of intervention at 12 weeks
Binge Eating
Time Frame: From enrollment to the end of intervention at 12 weeks

Eating behavior disorder where a person tends to overeat and has difficulty controlling it is assessed from a total score of 16 statements using Binge Eating Scale Questionnaire. The total score ranges from 0 to 46, with higher scores correlating with more frequent and severe binge eating behaviors. Based on the total scores, it can be classified into distinct severity categories as follows:

  1. Low Binge-Eating: Scores of 17 or lower;
  2. Mild to Moderate Binge-Eating: Scores ranging from 18 to 26;
  3. Severe Binge-Eating: Scores of 27 or higher, indicating a high frequency and severity of binge-eating symptoms.
From enrollment to the end of intervention at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aryono Hendarto, PhD, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-07-1125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Obesity

Clinical Trials on Nutrition and Physical Activity Education with Mindful Eating Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe