Status:
RECRUITING
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
Lead Sponsor:
Drexel University
Conditions:
Overweight and Obesity
Eligibility:
FEMALE
14-19 years
Phase:
NA
Brief 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-b...
Detailed Description
Overweight/obesity (OW/OB) affects 14 million adolescents in the U.S. and disproportionately affects girls and racial/ethnic minorities while increasing their risk of cardiovascular disease (CVD) and ...
Eligibility Criteria
Inclusion
- Ages 14-19
- Gender identification as girl
- BMI percentile ≥ 85th percentile for sex-and-age
Exclusion
- 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
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06147973
Start Date
February 14 2024
End Date
January 1 2028
Last Update
April 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Drexel University
Philadelphia, Pennsylvania, United States, 19104