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Clinical Trials/NCT00365807
NCT00365807
Completed
Not Applicable

Effectiveness of a Treatment Program for Pediatric Obesity

University of Kansas2 sites in 1 country93 target enrollmentJuly 2006
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Kansas
Enrollment
93
Locations
2
Primary Endpoint
BMI Percentile Change
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
May 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

BMI Percentile Change

Time Frame: Treatment completion, 1 year follow up

Secondary Outcomes

  • 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)

Study Sites (2)

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