Clinical trial NCT06821555: Mindful Eating Intervention Using EATS UP App: Effects on Body Composition and Insulin Resistance in Obese Adolescents
Official title: Pengembangan Model Mindful Eating Intervention Dengan Aplikasi (EATS UP) Pada Remaja Obes Dan Pengaruhnya Terhadap Komposisi Tubuh Dan Resistensi Insulin (Indonesia Language)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Obesity
Eating Behaviors
Nutrition Status
Blood Glucose
Body Fat Composition
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 64
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Body Composition
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Fasting Blood Sugar Levels
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Fasting Insulin Levels
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Insulin Resistance
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Mindful Eating Score
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Eating Behavior
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Binge Eating
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Sleep Quality
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Physical Activity Level
timeFrame: From enrollment to the end of intervention at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Universitas Indonesia
Study officials:
affiliation: Indonesia University
name: Aryono Hendarto, PhD
role: PRINCIPAL_INVESTIGATOR
References: