The Healthy Families Project (HF)
2011年5月23日 更新者：Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Promoting Healthy Families Through Enhanced Primary Care
A primary care approach to obesity prevention will be developed and tested in a randomized trial in 4 pediatric primary care practices.
Enhanced screening for obesity risks and prompts for effective counseling at well visits of 4 to 10 year olds will be developed utilizing hand held technology( PDAs).
The impact on the content and quality of clinician counseling will be assessed in exit survey prior to and after implementation.
Among families interested in making a change to address nutrition or activity risk reported on the screener a cohort with children > BMI 85% will be recruited.
They will be randomized to mailed tailored supports to level of readiness to change versus a single generic informational mailing.
The hypotheses are that 1)families that receive the enhanced office visit with screening will be more likely to plan to make changes compared to usual care; and 2) families receiving the tailored post visit supports will be less likely to gain weight than controls after 6 months.
研究概览
地位
完全的
条件
详细说明
- Using hand held PDAs, we will develop an obesity risk screening and counseling system for 4 through 10 year olds attending primary care well child visits. Screening results will be summarized immediately by the PDA and will prompt the clinician to provide brief counseling messages tailored to each childís obesity screening results, including the familyís and the childís readiness to change behavior
- We will evaluate the specific content and quality of clinician obesity counseling provided at the well child visit through parent surveys before and after implementation of the PDA screening and counseling program.
- To support action by families after the office visit, we will develop a post-visit intervention package of newsletters and materials that are tailored to child/family obesity risk behaviors and parental readiness to change.
- We will evaluate the impact of this post visit intervention program in a 6 month trial focused on children identified at well child screening to have BMI >85%. 200 Families will be randomized to receive either a series of mailed supports over 3 months versus a single generic-content mailing. We will determine the respective impact of these two levels of post-visit support on stage of change, parental action on key obesity risk behaviors, and stabilization of BMI z scores after 6 months.
研究类型
介入性
注册 (实际的)
149
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
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756-0001
- Dartmouth Hitchcock Medical Center
-
Lebanon、New Hampshire、美国、03756-0001
- Dartmouth Medical School, Dartmouth Hitchcock Medical Center
-
-
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
4年 至 10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:
- Families with children ages 4 to 11 years
- For post visit supports; Children > 85% for age BMI
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 |
|---|---|
|
实验性的：Parent/child tailored mailed materials
Family provided newsletters tailored to issues and readiness to change.
Family receives educational nutrition DVD, pedometers for family activities and child nutrition/physical activity games
|
PDA based health risk screening for well child issues and obesity risks
其他名称：
Specific tailoring for those interested in change vs not .
Two newsletters over 3 mpn.
其他名称：
|
|
有源比较器：Basic information at single time
Family provided with high quality booklet from American Dietetic Association providing the same information that intervention arm received but not tailored.
|
PDA based health risk screening for well child issues and obesity risks
其他名称：
Booklet by ADA sent x 1.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BMI z score
大体时间：6 months
|
Prevention of increase in BMI
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Parental readiness to initiate change
大体时间：immediately post well visit
|
Exit surveys comparing parents with PDA screening vs not for readiness to make changes
|
immediately post well visit
|
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：Ardis L Olson, MD、Dartmouth Medical School, Dept. of Pediatrics
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
2007年2月1日
初级完成 (实际的)
2008年3月1日
研究完成 (实际的)
2009年8月1日
研究注册日期
首次提交
2010年8月31日
首先提交符合 QC 标准的
2010年8月31日
首次发布 (估计)
2010年9月1日
研究记录更新
最后更新发布 (估计)
2011年5月24日
上次提交的符合 QC 标准的更新
2011年5月23日
最后验证
2011年5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.