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

University of Florida1 site in 1 country43 target enrollmentJuly 21, 2020

ConditionsWeight Loss Obesity Overweight

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Weight Loss
Sponsor: University of Florida
Enrollment: 43
Locations: 1
Primary Endpoint: BMI Change, 95th BMI Percentile (%)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 21, 2020

End Date

July 22, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Florida

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

BMI Change, 95th BMI Percentile (%)

Time Frame: 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 Outcomes

Change in Quality of Life(Baseline; Month 6)
Change in Depression Using the Valid Beck Depression Inventory-II(Baseline; Month 6)
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment(Baseline; Month 6)