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

NCT ID: NCT06821555

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-02-28

Brief Summary

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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

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Conditions

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Adolescent Obesity Eating Behaviors Nutrition Status Blood Glucose Body Fat Composition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Nutrition and Physical Activity with Mindful Eating Intervention

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

Group Type EXPERIMENTAL

Nutrition and Physical Activity Education with Mindful Eating Intervention

Intervention Type 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

The control group receiving only nutrition and physical activity education

Group Type EXPERIMENTAL

Nutrition and Physical Activity Education

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Nutrition and Physical Activity Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Aryono Hendarto

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aryono Hendarto, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Universitas Indonesia

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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23-07-1125

Identifier Type: -

Identifier Source: org_study_id

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