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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484831
• Other study ID #: IRB201701609
• Secondary ID: K01HL141535PA-16
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: July 22, 2022

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 22, 2022
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• ABT Weight Loss Intervention
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.

Other:
• Enhanced Care
This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	National Heart, Lung, and Blood Institute (NHLBI), StayWell, WellCare Health Plans, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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