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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Brief Family Intervention (Primarily education); Behavioral: Positively Fit

• Registration Number: NCT00365807
• Lead Sponsor: University of Kansas

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-18
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Family Intervention (Primarily education)	Brief Family Intervention (Primarily education)	Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact
Positively Fit	Positively Fit	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.

Primary Outcome Measures

Name	Time	Method
BMI Percentile Change	Treatment completion, 1 year follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University of Kansas; 🇺🇸 Lawrence, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States