- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04484831
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABT Weight Loss Intervention
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.
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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.
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Placebo Comparator: Enhanced Care
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.
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This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI Change, 95th BMI Percentile (%)
Time Frame: Baseline; Month 6
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: 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.
|
Baseline; Month 6
|
Change in Depression Using the Valid Beck Depression Inventory-II
Time Frame: Baseline; Month 6
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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
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Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
Time Frame: Baseline; Month 6
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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.
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Baseline; Month 6
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle I Cardel, PhD, MS, RD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201701609
- K01HL141535 (U.S. NIH Grant/Contract)
- PA-16-190 (Other Grant/Funding Number: NIH NHLBI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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