An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Recruiting now · Not applicable

Conditions studied: Overweight and Obesity

In brief

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.

Key facts

Study ID

NCT06147973

Run by

Nemours Children's Clinic

People needed

148

Starts

2024-02-14

Expected to finish

2028-01-01

Last updated by the study team

2026-07-20

Who can join

Age: 14 and older, up to 19. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Ages 14-19
• Gender identification as girl
• BMI percentile ≥ 85th percentile for sex-and-age

You may not qualify if…

• 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

• Drexel University — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.