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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365807
Recruitment Status : Completed
First Posted : August 18, 2006
Last Update Posted : November 5, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Positively Fit Other: Brief Family Intervention (Primarily education) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Treatment Program for Pediatric Obesity
Study Start Date : July 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001) [ Time Frame: treatment completion, one year follow up ]
  2. 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 ]
  3. Cost-effectiveness [ Time Frame: Treatment completion, one year follow up ]
  4. Consumer Satisfaction [ Time Frame: Treatment completion ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: University of Kansas Identifier: NCT00365807     History of Changes
Other Study ID Numbers: R40MC06631-01-00
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: November 5, 2012
Last Verified: November 2012

Keywords provided by University of Kansas:
Behavioral treatment
Family involvement

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