An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
Recruiting · NCT06147973 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 the trial
Where it is running
1 location listed across 1 US state.
- Drexel University - Philadelphia, Pennsylvania, United States