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

NCT06821555 | Completed

• 1 other identifier: 23-07-1125
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Body Composition

  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

  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

  Measures the amount of insulin in the blood during fasting.

  From enrollment to the end of intervention at 12 weeks

• Insulin Resistance

  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

• Mindful Eating Score

  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

• Eating Behavior

  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

• Binge Eating

  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

• Sleep Quality

  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

  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

Study Arms (2)

Nutrition and Physical Activity with Mindful Eating Intervention

EXPERIMENTAL

The intervention group receiving nutrition and physical activity with mindful eating intervention

Behavioral: Nutrition and Physical Activity Education with Mindful Eating Intervention

Nutrition and Physical Activity Education

EXPERIMENTAL

The control group receiving only nutrition and physical activity education

Behavioral: Nutrition and Physical Activity Education

Interventions

Nutrition and Physical Activity Education with Mindful Eating Intervention BEHAVIORAL

Mindful Eating Intervention applied to Obesity treatment for Adolescent alongside with Nutrition and Physical Activity Education from Nutritionist and Psychologist

Nutrition and Physical Activity with Mindful Eating Intervention

Nutrition and Physical Activity Education BEHAVIORAL

Nutrition and physical activity education from Nutritionist applied as Obesity treatment for Adolescent

Nutrition and Physical Activity Education

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Aryono Hendarto, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: March 18, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)