N/A
N=34
Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
Pediatric Obesity · Executive Function
Bottom Line
View on ClinicalTrials.gov: NCT03329300 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change From Baseline Child Body Fat Mass at 6 Months — -.96 %bf tblh (total body less head)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Family-based Behavioral Treatment (FBT) (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Child Body Fat Mass at 6 Months |
-.96 | — |
| SECONDARY Adherence to Treatment (Number of Contact Hours) |
11.48 | — |
| SECONDARY Adherence to Treatment (Completed Days of Self-monitoring) |
— | — |
Summary
We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.
Eligibility Criteria
Inclusion Criteria
- Have a BMI ≥ 85th percentile
- Are ≥8 and ≤12 years old at the beginning of treatment
- Can read, write, and speak English, along with their parent
- Plan to stay living within the local area during the study period
- Have a consenting parent who can commit to all study procedures and provide reliable travel.
- Siblings will be eligible for study inclusion if they meet the above criteria and will be allowed to use the same participating parent (sibling effects would then be addressed in statistical analyses).
Exclusion Criteria
- Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
- Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
- Have been diagnosed with an intellectual disability or traumatic brain injury
- Have medical contraindications to physical activity.
Data sourced from ClinicalTrials.gov (NCT03329300). 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.