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

September 20, 2023 updated by: University of Florida

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

The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline; Month 6

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

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
Time Frame: Baseline; Month 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
StayWell
WellCare Health Plans, Inc.

Investigators

  • Principal Investigator: Michelle I Cardel, PhD, MS, RD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2020

Primary Completion (Actual)

July 7, 2021

Study Completion (Actual)

July 22, 2022

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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