A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
- Conditions
- OverweightObesityWeight Loss
- Registration Number
- NCT04484831
- Lead Sponsor
- University of Florida
- Brief Summary
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
- Detailed Description
Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.
The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.
Post-treatment assessments will occur.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 43
- Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts
- Known pregnancy or plans to become pregnant in the next 2 years
- Plans to move out of the area in the next year
- Autism, any intellectual disability (e.g., down syndrome)
- Any condition prohibiting physical activity
- A diagnosis of cardiovascular disease or diabetes
- Have active cancer or cancer requiring treatment in the past 2 years
- Have active or chronic infections (e.g., HIV or TB)
- Have active kidney disease or lung disease
- An eating disorder or substance abuse disorder
- Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
- Weight loss greater than or equal to 5% in the previous 6 months
- If they do not follow the study plan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method BMI Change, 95th BMI Percentile (%) Baseline; Month 6 Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life Baseline; Month 6 Measurements of quality of life (using the valid Pediatric Quality of Life Inventory assessment: scores 0-100) will be conducted. Higher scores indicate better health-related quality of life.
Change in Depression Using the Valid Beck Depression Inventory-II Baseline; Month 6 Depression is measured with the Beck Depression Inventory- II (BDI-II). The BDI-II measures the severity of depression. Each item is assessed on a 4-point ordinal categorical scale (0-3 points) that is specific to the question subject matter being addressed (e.g. sadness, self-criticalness, loss of pleasure, etc), and then answer choices are summed to generate a total score. The BDI-II is reliable and valid in an adolescent population.
Participants receive a sum-score (ranging from 0-63), which correlates with a certain classification and level of depression. Scores 1-10 (normal ups and downs) and 11-16 (mild mood disturbance) are classified as low. Scores 17-20 (borderline clinical depression) and 21-30 (moderate depression) are classified as moderate. Scores 31-40 (severe depression) and 40+ (extreme depression) are classified as significant.Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment Baseline; Month 6 Measurements of anxiety-sensitivity (using the valid Short Scale Anxiety Sensitivity Index-3 assessment: scores 0-20) will be conducted. Higher scores indicate higher anxiety-sensitivity.
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States
University of Florida🇺🇸Gainesville, Florida, United States