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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management

Conditions
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Pediatric Obesity, Executive Function

Intervention / Treatment
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* Behavioral: Family-based Behavioral Treatment (FBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All participants<br>Family-based Behavioral Treatment (FBT) | Behavioral: Family-based Behavioral Treatment (FBT)<br>* Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Child Body Fat Mass at 6 Months | Dual-energy X-ray Absorptiometry (DXA) | Baseline to 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Executive Function, Behavioral Intervention