NCT04484831

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

Completed NA Results posted Last updated 12 October 2023

What this trial tests

NA trial testing ABT Weight Loss Intervention in Weight Loss in 43 participants. Completed in 22 July 2022.

Timeline

21 July 2020

Primary endpoint
7 July 2021

22 July 2022

Quick facts

Lead sponsor	University of Florida
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	43
Start date	21 July 2020
Primary completion	7 July 2021
Estimated completion	22 July 2022
Sites	1 location across United States

Drugs / interventions tested

• ABT Weight Loss Intervention
• Enhanced Care

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Obesity — all drugs for Obesity →
• Overweight — all drugs for Overweight →

Sponsor

University of Florida

Who can join

Adults 14 to 19, female only, with Weight Loss or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

BMI Change, 95th BMI Percentile (%) Primary · 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.

Group	Value	95% CI
ABT Weight Loss Intervention	-1.11	± 5.93
Enhanced Care	-0.08	± 8.05

Change in Quality of Life Secondary · 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.

Group	Value	95% CI
ABT Weight Loss Intervention	2.94	± 10.86
Enhanced Care	3.12	± 11.15

Change in Depression Using the Valid Beck Depression Inventory-II Secondary · 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

Group	Value	95% CI
ABT Weight Loss Intervention	-2.81	± 11.58
Enhanced Care	0.71	± 12.26

Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment Secondary · 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.

Group	Value	95% CI
ABT Weight Loss Intervention	1.00	± 3.65
Enhanced Care	1.00	± 5.63

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity.
   Newsome FA, Cardel MI, Chi X, Lee AM, et al · · 2023 · cited 3× · PMID 36394498 · DOI 10.1089/chi.2022.0116