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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial

Conditions
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Weight Loss, Obesity, Overweight

Intervention / Treatment
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* Behavioral: ABT Weight Loss Intervention
* Other: Enhanced Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT Weight Loss Intervention<br>Adolescent 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. | Behavioral: ABT Weight Loss Intervention<br>* This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.<br>|
| Placebo Comparator: Enhanced Care<br>Adolescent 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. | Other: Enhanced Care<br>* This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Change, 95th BMI Percentile (%) | 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. | Baseline; Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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. | Baseline; Month 6 | 
| Change in Depression Using the Valid Beck Depression Inventory-II | 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. | Baseline; Month 6 | 
| Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment | 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. | Baseline; Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight