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Completed

NCT Number: NCT00365807

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

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.

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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positively Fit

Behavioral

12-week group intervention for children with obesity and their parents/caregivers

Brief Family Intervention (Primarily education)

Other

3 hours of contact with registered dietician for education and nutritional counseling.

Primary outcomes

  1. BMI Percentile Change

    Time frame: Treatment completion, 1 year follow up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

Effectiveness of a Treatment Program for Pediatric Obesity

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Aug 18, 2006
Registry last updated
Nov 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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