Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Study Overview
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Brief Summary
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The purpose of this study is to develop a Social Network Engagement (SNE) Intervention that will be integrated into a standard treatment program for childhood overweight. The investigators will conduct a pilot trial of SNE to assess feasibility and to estimate its effectiveness compared with historical controls who received standard treatment. The historical controls will be participants in the FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629).

Official Title
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Enhancing Family Based Treatment of Childhood Obesity Through Social Networks

Conditions
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Child Obesity

Intervention / Treatment
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* Behavioral: Social Network Engagement+Std Treatment
* Behavioral: Standard Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Children Age 7-13 years At or above the 85th percentile for age- and gender-specific BMI Parents • At least one overweight parent (BMI>25.0) Parents and children English-speaking and at least at a second-grade reading level Live <50 miles from the treatment site. Exclusion Children Conditions known to promote obesity (e.g., Prader-Willi), Participation in another weight control program Recently started taking weight-affecting medications (e.g., stimulants). Parents and children Disability or illness that would preclude them from engaging in at least moderate-intensity physical activity, Current or prior diagnosed eating disturbance Thought disorder, suicidality, or substance abuse disorder

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Social Network Engagement+Std Treatment<br>Social Network Engagement = content and activities to help the parent engage his/her social network in supporting healthy lifestyle behaviors. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629) | Behavioral: Social Network Engagement+Std Treatment<br> <br> * Other names: SNE;|
| Other: Standard Treatment<br>This comparator arm consists of historical controls, participants in the FOCUS trial who received standard treatment. Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629) | Behavioral: Standard Treatment<br>* Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)<br>* Other names: FOCUS Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child BMI Z-score |  | 20 weeks after baseline | 
| Child BMI Z-score |  | One year post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peds QL (child self-report and parent report) | Pediatric Quality of Life Score | 20 weeks after baseline | 
| Parent BMI | Intervention is aimed at the parent-child dyad, so parent weight status is assessed. | 20 weeks after baseline | 
| Peds QL (child self-report and parent report) | Pediatric Quality of Life Score | One year post-treatment | 
| Parent BMI | Intervention is aimed at the parent-child dyad, so parent weight status is assessed. | One year post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, child, weight management, behavioral, social networks, social support