Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life

Not Applicable

Completed

• Conditions: Executive Function; Pediatric Obesity
• Interventions: Behavioral: Family-based Behavioral Treatment (FBT)

• Registration Number: NCT03329300
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Baseline assessments will include child and parent demographic data, medical history, and cognitive functioning, along with anthropometric measures such as height, weight, and body composition. Those who complete baseline assessments will be enrolled in one of two groups of family-based treatment on after-school evenings (8 pairs in each group; total of 16 child-caregiver pairs). A total of 24 weekly treatment sessions lasting up to 90 minutes each will be held over 6 months. Family-based behavioral treatment is a manualized, group intervention for children with obesity and their caregivers that incorporate participant-driven goal-based changes in diet and physical activity, and a variety of interactive educational session topics and behavioral support for reaching goals. A private weigh-in for children and caregivers will be conducted at each session. Sessions will begin with check-in with each family about weekly goal progress, after which the caregivers and children will split into separate groups for session-specific content including educational material tailored to nutrition, eating, and activity. The final portion of group session will involve children and caregivers merging in one group to share learning experiences and engage in collaborative goal-setting for the upcoming week(s). After the six month family-based behavioral intervention, baseline measures will be reassessed as well as overall program adherence. Program adherence will be evaluated using weekly program attendance and the number of days dietary/physical activity self-monitoring logs were completed.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2018-06-04
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Results First Submitted: 2022-04-13
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Results First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Have a BMI ≥ 85th percentile

2. Are ≥8 and ≤12 years old at the beginning of treatment

3. Can read, write, and speak English, along with their parent

4. Plan to stay living within the local area during the study period

5. 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).

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Exclusion Criteria

1. Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
2. 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
3. Have been diagnosed with an intellectual disability or traumatic brain injury
4. Have medical contraindications to physical activity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Family-based Behavioral Treatment (FBT)	Family-based Behavioral Treatment (FBT)

Primary Outcome Measures

Name	Time	Method
Change From Baseline Child Body Fat Mass at 6 Months	Baseline to 6 months	Dual-energy X-ray Absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
Adherence to Treatment (Completed Days of Self-monitoring)	Baseline to 6 months	The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.
Adherence to Treatment (Number of Contact Hours)	Baseline to 6 months	The number of contact hours participant was exposed to treatment

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States