← Back to all trials
Recruiting
NCT06147973
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
Conditions: Overweight and Obesity
Sex: Female
Ages: 14 Years – 19 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 148
Sponsor: Nemours Children's Clinic
Location: Drexel University Philadelphia Pennsylvania
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06147973). StuddyBuddy aggregates publicly available trial information.