Healthy Eating, Activity and Reduction of Teen Stress (NCT04038684) | Clinical Trial Compass
CompletedNot Applicable
Healthy Eating, Activity and Reduction of Teen Stress
United States139 participantsStarted 2019-07-02
Plain-language summary
The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. We aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 13-18 years old
. BMI in the overweight or obese range (≥ 85th%ile for age and sex)
. speak English
Exclusion criteria
. use of medications that have recently resulted in a change in eating or weight
. cognitive impairment/developmental delay such that study procedures would be inappropriate
. major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Adolescent Body Mass Index (BMI)
Timeframe: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
2
Change in Adolescent Emotional Eating
Timeframe: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
3
Change in Adolescent Perceived Stress
Timeframe: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
4
Change in Adolescent Stress
Timeframe: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
5
Change in Adolescent Chronic Stress
Timeframe: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
6
Intervention Acceptability and Feasibility
Timeframe: End of treatment (approx 14 weeks after baseline)