A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
Primary Purpose
Weight Loss, Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ABT Weight Loss Intervention
Enhanced Care
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
Eligibility Criteria
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
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ABT Weight Loss Intervention
Enhanced Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04484831
First Posted
July 21, 2020
Last Updated
September 20, 2023
Sponsor
University of Florida
Collaborators
StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04484831
Brief Title
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
Official Title
An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
July 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
StayWell, National Heart, Lung, and Blood Institute (NHLBI), WellCare Health Plans, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity, Overweight
Keywords
acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT Weight Loss Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ABT Weight Loss Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Care
Intervention Description
This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
Primary Outcome Measure Information:
Title
BMI Change, 95th BMI Percentile (%)
Description
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.
Time Frame
Baseline; Month 6
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline; Month 6
Title
Change in Depression Using the Valid Beck Depression Inventory-II
Description
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.
Time Frame
Baseline; Month 6
Title
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
Description
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.
Time Frame
Baseline; Month 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle I Cardel, PhD, MS, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
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