Effectiveness of a Treatment Program for Pediatric Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- BMI Percentile Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
BMI Percentile Change
时间窗: Treatment completion, 1 year follow up
次要结局
- Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)(treatment completion, one year follow up)
- 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)(Treatment completion, one year follow up)
- Cost-effectiveness(Treatment completion, one year follow up)
- Consumer Satisfaction(Treatment completion)