Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families
2012年11月2日 更新者：University of Kansas
Effectiveness of a Treatment Program for Pediatric Obesity
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
93
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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Lawrence、Kansas、美国、66045
- University of Kansas
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
7年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Brief Family Intervention (Primarily education)
Behaviorally based family group intervention using standard education and nutrition counseling.
Three hours of client contact
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3 hours of contact with registered dietician for education and nutritional counseling.
|
|
实验性的：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.
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12-week group intervention for children with obesity and their parents/caregivers
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
BMI Percentile Change
大体时间：Treatment completion, 1 year follow up
|
Treatment completion, 1 year follow up
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Quality of Life - The PedsQL™ (version 4.0;Varni et al., 2001)
大体时间：treatment completion, one year follow up
|
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)
大体时间：Treatment completion, one year follow up
|
Treatment completion, one year follow up
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Cost-effectiveness
大体时间：Treatment completion, one year follow up
|
Treatment completion, one year follow up
|
|
Consumer Satisfaction
大体时间：Treatment completion
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Treatment completion
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ric G Steele, Ph.D.、University of Kansas
- 首席研究员：Ann M. Davis, Ph.D.、University of Kansas Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年7月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2006年8月17日
首先提交符合 QC 标准的
2006年8月17日
首次发布 (估计)
2006年8月18日
研究记录更新
最后更新发布 (估计)
2012年11月4日
上次提交的符合 QC 标准的更新
2012年11月2日
最后验证
2012年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.