N/A
N=40
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity
Weight Loss · Obesity · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT04484831 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: BMI Change, 95th BMI Percentile (%) — -1.11; -0.08 Change in the 95th BMI percentile %
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ABT Weight Loss Intervention (Behavioral); Enhanced Care (Other)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University of Florida
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI Change, 95th BMI Percentile (%) |
-1.11; -0.08 | — |
| SECONDARY Change in Quality of Life |
2.94; 3.12 | — |
| SECONDARY Change in Depression Using the Valid Beck Depression Inventory-II |
-2.81; 0.71 | — |
| SECONDARY Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment |
1.00; 1.00 | — |
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.
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
- Weight loss greater than or equal to 5% in the previous 6 months
- If they do not follow the study plan
Data sourced from ClinicalTrials.gov (NCT04484831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.