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

This study has been completed.
Information provided by (Responsible Party):
University of Kansas Identifier:
First received: August 17, 2006
Last updated: November 2, 2012
Last verified: November 2012
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.

Condition Intervention
Behavioral: Positively Fit
Other: Brief Family Intervention (Primarily education)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Treatment Program for Pediatric Obesity

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • BMI Percentile Change [ Time Frame: Treatment completion, 1 year follow up ]

Secondary Outcome Measures:
  • Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001) [ Time Frame: 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) [ Time Frame: Treatment completion, one year follow up ]
  • Cost-effectiveness [ Time Frame: Treatment completion, one year follow up ]
  • Consumer Satisfaction [ Time Frame: Treatment completion ]

Enrollment: 93
Study Start Date: July 2006
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brief Family Intervention (Primarily education)
Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact
Other: Brief Family Intervention (Primarily education)
3 hours of contact with registered dietician for education and nutritional counseling.
Experimental: 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.
Behavioral: Positively Fit
12-week group intervention for children with obesity and their parents/caregivers

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.

Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00365807

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
University of Kansas
Lawrence, Kansas, United States, 66045
Sponsors and Collaborators
University of Kansas
Principal Investigator: Ric G Steele, Ph.D. University of Kansas
Principal Investigator: Ann M. Davis, Ph.D. University of Kansas Medical Center
  More Information

Responsible Party: University of Kansas Identifier: NCT00365807     History of Changes
Other Study ID Numbers: R40MC06631-01-00
Study First Received: August 17, 2006
Last Updated: November 2, 2012

Keywords provided by University of Kansas:
Behavioral treatment
Family involvement

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 24, 2017