Clinical trial NCT00365807: Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
Official title: Effectiveness of a Treatment Program for Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Behavioral treatment
Family involvement
Lead sponsor: University of Kansas
Sponsor class: OTHER
First posted: 2006-08-18
Enrollment: 93
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BMI Percentile Change
timeFrame: Treatment completion, 1 year follow up
Secondary outcomes:
measure: Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
timeFrame: treatment completion, one year follow up
measure: 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)
timeFrame: Treatment completion, one year follow up
measure: Cost-effectiveness
timeFrame: Treatment completion, one year follow up
measure: Consumer Satisfaction
timeFrame: Treatment completion
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Ric G Steele, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Ann M. Davis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steele RG, Aylward BS, Jensen CD, Cushing CC, Davis AM, Bovaird JA. Comparison of a family-based group intervention for youths with obesity to a brief individual family intervention: a practical clinical trial of positively fit. J Pediatr Psychol. 2012 Jan-Feb;37(1):53-63. doi: 10.1093/jpepsy/jsr057. Epub 2011 Aug 18.