An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents (NCT06147973) | Clinical Trial Compass
RecruitingNot Applicable
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
United States148 participantsStarted 2024-02-14
Plain-language summary
The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are:
1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?
2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention?
Participants in this trial will:
1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform.
2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity.
Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.
Who can participate
Age range
14 Years – 19 Years
Sex
FEMALE
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:
* Ages 14-19
* Gender identification as girl
* BMI percentile ≥ 85th percentile for sex-and-age
Exclusion Criteria:
* Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss
* Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
* Plans to move out of the area within the next year
* Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
* Active or chronic infections (e.g., HIV or TB)
* Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
* Active kidney disease
* History of bariatric surgery
* Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
* Diagnosed diabetes (type 1 or 2)
* Any condition prohibiting physical activity
* Diagnosis of an eating disorder
* Have a mental handicap or are currently experiencing other severe psychopathology that would limit their ability to engage in the treatment program (e.g., severe depression, active psychotic disorder)
* Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
* Currently pregnant or less than 3 months post-partum
* Anticipation of a possible pregnancy in the next year
* Unwillingness to report possible or confirmed pregnancies promptly during the course of t…
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.