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Completed

NCT Number: NCT04484831

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

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

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT Weight Loss Intervention

Behavioral

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.

Enhanced Care

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 24, 2020
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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