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A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity

Not Applicable
Completed
Conditions
Overweight
Obesity
Weight Loss
Interventions
Other: Enhanced Care
Behavioral: ABT Weight Loss Intervention
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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Arm && Interventions
GroupInterventionDescription
Enhanced CareEnhanced CareAdolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
ABT Weight Loss InterventionABT Weight Loss InterventionAdolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Change in Quality of LifeBaseline; 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-IIBaseline; 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 AssessmentBaseline; 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

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