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

Not Applicable

Completed

• Conditions: Adolescent Obesity; Eating Behaviors; Nutrition Status; Blood Glucose; Body Fat Composition

• Registration Number: NCT06821555
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Composition	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,
Fasting Blood Sugar Levels	From enrollment to the end of intervention at 12 weeks	Blood glucose examination is carried out after fasting for 10 - 12 hours.
Fasting Insulin Levels	From enrollment to the end of intervention at 12 weeks	Measures the amount of insulin in the blood during fasting.
Insulin Resistance	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.
Mindful Eating Score	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.
Eating Behavior	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)
Binge Eating	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.
Sleep Quality	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.
Physical Activity Level	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)

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta, Indonesia