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Completed

NCT Number: NCT06821555

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

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.

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Key information

Conditions

Adolescent Obesity Behavior Behavior, Animal Blood Glucose Body Fat Composition Body Weight Eating Behaviors Feeding Behavior Nutrition Disorders Nutrition Status Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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 Education

Behavioral

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

Primary outcomes

  1. 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,

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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:

    • Low Binge-Eating: Scores of 17 or lower;
    • Mild to Moderate Binge-Eating: Scores ranging from 18 to 26;
    • Severe Binge-Eating: Scores of 27 or higher, indicating a high frequency and severity of binge-eating symptoms.

  8. 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.

  9. 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)

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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