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

Kansas Board of Regents

Status: Completed

Conditions: Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00365807

R40MC06631-01-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Brief Family Intervention (Primarily education)

Active Comparator group

Description:

Behaviorally based family group intervention using standard education and nutrition counseling. Three hours of client contact

Treatment:

Other: Brief Family Intervention (Primarily education)

Positively Fit

Experimental group

Description:

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.

Treatment:

Behavioral: Positively Fit