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临床试验/NCT01066910
NCT01066910已完成不适用

Parents As The Agent Of Change For Childhood Obesity (PAAC)

University of Minnesota2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Child BMI percentile, Child BMI, Child BMI_Z

研究概览

简要总结

The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. These treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. We are currently implementing this treatment in the Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment protocol for 30 years.

详细描述

The objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. The central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. The specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity.

The primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity.

The secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment.

This study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. The two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. Study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • An overweight child (>95th%) in the family who is between the ages of 8-
  • A parent willing to participate and attend all treatment meetings.
  • Family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment.
  • Family willing to submit the $60 deposit.

排除标准

  • Child psychiatric disorder diagnoses (based on parent report).
  • Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed.
  • Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home.
  • Child with physical difficulties that limit the ability to exercise.
  • Child with an active eating disorder.
  • All exclusionary and inclusionary criteria are similar to those in previous studies of Epstein and colleagues and Golan and colleagues.

结局指标

主要结局

Child BMI percentile, Child BMI, Child BMI_Z

时间窗: 11 months

次要结局

  • Parent BMI, Child nutritional intake, Child physical activity(11 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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