Adolescent ObesityNCT06821555
Mindful Eating Intervention Using EATS UP App: Effects on Body Composition and Insulin Resistance in Obese Adolescents
A study testing Nutrition and Physical Activity Education with Mindful Eating Intervention and Nutrition and Physical Activity Education in people with Adolescent Obesity and Eating Behaviors, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Adolescent Obesity, Eating Behaviors, Nutrition Status
- What is being tested?
- Nutrition and Physical Activity Education with Mindful Eating Intervention and Nutrition and Physical Activity Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pengembangan Model Mindful Eating Intervention Dengan Aplikasi (EATS UP) Pada Remaja Obes Dan Pengaruhnya Terhadap Komposisi Tubuh Dan Resistensi Insulin (Indonesia Language)
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:
Read more
- 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
- Being tested
- Nutrition and Physical Activity Education with Mindful Eating Intervention, Nutrition and Physical Activity Education
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and Physical Activity Education with Mindful Eating InterventionBehavioural
Mindful Eating Intervention applied to Obesity treatment for Adolescent alongside with Nutrition and Physical Activity Education from Nutritionist and Psychologist
Nutrition and Physical Activity EducationBehavioural
Nutrition and physical activity education from Nutritionist applied as Obesity treatment for Adolescent
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Physical Activity with Mindful Eating Intervention | Experimental | The intervention group receiving nutrition and physical activity with mindful eating intervention Receives: 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 Receives: Behavioral: Nutrition and Physical Activity Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: From enrollment to the end of intervention at 12 weeks
Fasting Insulin Levels
Measures the amount of insulin in the blood during fasting.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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:
- 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.
Measured: 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.
Measured: 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)
Measured: From enrollment to the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start18 Mar 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aryono Hendarto, Universitas Indonesia
- Investigators
- Aryono Hendarto, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821555
- Sponsor's protocol ID
- 23-07-1125
- Status last verified
- Apr 2025
- First submitted
- 6 Feb 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pengembangan Model Mindful Eating Intervention Dengan Aplikasi (EATS UP) Pada Remaja Obes Dan Pengaruhnya Terhadap Komposisi Tubuh Dan Resistensi Insulin (Indonesia Language)
- ClinicalTrials.gov ID
- NCT06821555
- Acronym / sponsor ID
- 23-07-1125
- Conditions
- Adolescent Obesity, Eating Behaviors, Nutrition Status, Blood Glucose, Body Fat Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Physical Activity with Mindful Eating Intervention | Experimental | Behavioral: Nutrition and Physical Activity Education with Mindful Eating InterventionThe intervention group receiving nutrition and physical activity with mindful eating intervention |
| Nutrition and Physical Activity Education | Experimental | Behavioral: Nutrition and Physical Activity EducationThe control group receiving only nutrition and physical activity education |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition and Physical Activity Education with Mindful Eating InterventionMindful Eating Intervention applied to Obesity treatment for Adolescent alongside with Nutrition and Physical Activity Education from Nutritionist and Psychologist | Behavioural | Nutrition and Physical Activity with Mindful Eating Intervention |
| Nutrition and Physical Activity EducationNutrition and physical activity education from Nutritionist applied as Obesity treatment for Adolescent | Behavioural | Nutrition and Physical Activity Education |
Primary outcome
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,
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.
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.
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.
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.
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)
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: 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
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aryono Hendarto, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and Physical Activity Education with Mindful Eating Intervention and Nutrition and Physical Activity Education in people with Adolescent Obesity and Eating Behaviors, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: From enrollment to the end of intervention at 12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.