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Behavior Change Family Counseling to Reduce Rate of Weight Gain in At-Risk Children

2015年4月6日 更新者:Children's Hospital of Philadelphia

Primary Care Obesity Prevention: One or Multiple Targets

This study will train primary care providers to counsel families on behavior change that is aimed at reducing the rate of weight gain in at-risk children.

研究概览

详细说明

BACKGROUND:

In addition to family, school, and community, primary care is a promising setting for childhood obesity prevention. However, most pediatric primary care providers are not trained to deliver behavior modification interventions and, according to preliminary data, are less likely to address obesity prevention when they perceive insufficient time during well-care visits.

DESIGN NARRATIVE:

This is a controlled study of obesity prevention, with group randomization of two standardized 12-month intervention strategies at the practice level. The intervention strategies are based on the behavioral economics theory and will be delivered by primary care providers after training in behavior modification. The first strategy will target change in multiple behaviors, while the second strategy will target only one behavior (beverage consumption). These two interventions will be compared to an active control intervention that is unrelated to weight (bullying prevention). Six to seven primary care practices will be randomized to each arm with 21 patients per practice, for a total of 17 practices and 350 patients. The primary aim is to demonstrate that either obesity prevention intervention will result in less body mass index (BMI) increase (adjusted using z-score) in children age 8 to 12 years who are at risk for overweight (BMI 50th-95th percentile), as compared to a control intervention. The study also hypothesizes that the multiple-behavior intervention, the single-behavior intervention, or both will result in less adjusted BMI increase than the control intervention at 24 months post-randomization, with no a priori assumption in differences between the two obesity prevention strategies. Blood pressure, insulin resistance, dyslipidemia, and oral health status will be secondary outcomes. Intermediate behavioral outcomes and process data will be collected.

研究类型

介入性

注册 (实际的)

158

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • The Children's Hospital of Philadelphia

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

8年 至 12年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Sought care at the participating practices at least once in the 3 years prior to study entry
  • Children "at risk for overweight" at their last clinical visit (according to the Center for Disease Control and Prevention [CDC] definition of a BMI at or above the 50th percentile, but less than the 95th percentile)
  • Children who consume at least 28 oz of sweetened beverages per week (i.e., an average of 4 oz per day) as assessed during the telephone screening by selected components of a validated food frequency questionnaire
  • The following conditions will be acceptable if they have been well controlled in the 3 months prior to study entry: hypertension, dyslipidemia, sleep apnea, asthma, and insulin resistance without diabetes

Exclusion Criteria:

  • Developmental delay requiring special education
  • Depression
  • Psychosis
  • Eating disorder
  • Significant orthopedic problems interfering with physical activity
  • Diabetes
  • Any significant chronic condition potentially interfering with nutrition or physical activity
  • Treated with a drug known to affect weight gain
  • Measured BMI z-score at first visit higher than +2.0 Standard Deviations (97.7th percentile)
  • Families who are uninterested or unable to participate
  • Home-schooled

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:预防
  • 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
其他:Healthy Lifestyle (Active Intervention)
Parents and children in this program which will participate in a series of consultations and activities focused on multiple healthy interventions including healthy eating, drinking, and physical activity. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on healthy eating, drinking, and physical activity. In addition, your child will receive information on developing healthy interpersonal and social skills.
Focused on multiple behaviors (nutrition, beverages, physical activity, and sedentary lifestyle) which may have a significant impact on weight.
其他:Healthy Drinks (Active Intervention)
Parents and children in this program will participate in a series of consultations and activities focused on a single intervention, the effects of beverage choices on diet, general health and teeth health. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on beverages and health. In addition, your child will receive information on healthy nutrition, physical activity, and interpersonal and social skills.
Focused on changing beverage choices which may have a significant impact on weight.
其他名称:
  • Focused on changing beverage choices with the goal
其他:Social and Leadership Skills (Control Intervention)
Parents and children in this program will participate in a series of consultations that are designed to help your child learn strategies to make and keep friends, to express feelings appropriately, and to successfully decrease conflicts that often occur at school among children. The children will participate in a variety of age-appropriate games, activities and exercises that are focused on these friendship making strategies. In addition, your child will receive information on healthy nutrition and physical activity. There is o intervention with regards to healthy weight.
Focused on standard intervention strategies unrelated to weight including bullying prevention.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Changes in BMI z-score
大体时间:Measured at Month 12
Measured at Month 12

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:Stephen Leff, PhD、Children's Hospital of Philadelphia

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)

2011年5月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2005年10月17日

首先提交符合 QC 标准的

2005年10月17日

首次发布 (估计)

2005年10月19日

研究记录更新

最后更新发布 (估计)

2015年4月7日

上次提交的符合 QC 标准的更新

2015年4月6日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2005-7-4442
  • R01HL084056 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

Multiple behavior interventions的临床试验

3
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