Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families

Study Overview
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Brief Summary
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The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored.

Detailed Description
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The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL). Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.

Official Title
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Effectiveness of a Treatment Program for Pediatric Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Positively Fit
* Other: Brief Family Intervention (Primarily education)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child between ages 7 and 17 (inclusive) Child BMI at or above the 85th percentile based on norms provided for age and gender Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation Child's parent/caregiver is willing to participate with the child in the program Exclusion Criteria: Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Family Intervention (Primarily education)<br>Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact | Other: Brief Family Intervention (Primarily education)<br>* 3 hours of contact with registered dietician for education and nutritional counseling.<br>|
| Experimental: Positively Fit<br>12 week (90 minute per session) behavioral group intervention for children and their parents. Children and parent attend parallel group with identical (but developmentally appropriate) information presented. | Behavioral: Positively Fit<br>* 12-week group intervention for children with obesity and their parents/caregivers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI Percentile Change |  | Treatment completion, 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001) |  | treatment completion, one year follow up | 
| Child Psychosocial Adjustment -- the Behavioral Assessment System for Children- Parent report form (BASC-PRF) and the BASC-Child Self Report (BASC-CSR; Reynolds & Kamphaus, 2002) |  | Treatment completion, one year follow up | 
| Cost-effectiveness |  | Treatment completion, one year follow up | 
| Consumer Satisfaction |  | Treatment completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Behavioral treatment, Family involvement