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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00365807
First received: August 17, 2006
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • BMI Percentile Change [ Time Frame: Treatment completion, 1 year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001) [ Time Frame: treatment completion, one year follow up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: Treatment completion, one year follow up ] [ Designated as safety issue: No ]
  • Consumer Satisfaction [ Time Frame: Treatment completion ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365807

Locations
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
Investigators
Principal Investigator: Ric G Steele, Ph.D. University of Kansas
Principal Investigator: Ann M. Davis, Ph.D. University of Kansas
  More Information

Publications:

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00365807     History of Changes
Other Study ID Numbers: R40MC06631-01-00
Study First Received: August 17, 2006
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Obesity
Overweight
Behavioral treatment
Family involvement

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013