Wellness and Weight Family Group Project

Study Overview
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Brief Summary
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The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.

Official Title
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Wellness and Weight Family Group Project

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: Behavioral Family Intervention (BFI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender) child or adolescent is accompanied by a parent or legal guardian participating child and parent speak and read English family agrees to attend group meetings at a medical clinic over a 3 month period Exclusion Criteria: participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma) child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder) child or parent, according to parent report, in commercial weight loss program child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report parent and child do not speak and read English

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: Behavioral Family Intervention (BFI)<br> | Behavioral: Behavioral Family Intervention (BFI)<br>* Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Weight Status (BMIz) | BMIz calculated from measured child height and weight | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener | Child-report questionnaire | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Child Dietary Intake Total kcals from 24-hour dietary recall | Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Child A1C Values | From child medical chart - testing completed as part of standard medical care | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Child Glucose Values | From child medical chart - testing completed as part of standard medical care | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Parent Weight | Measured parent weight | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults | Parent-report questionnaire | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) | 
| Change in Parent Dietary Intake Total kcals from 24-hour dietary recall | Parent-report 24-hour dietary recall assessed via ASA24-2014 | Baseline, Post-Treatment (Month 3), and Follow-up (Month 5) |