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临床试验/NCT01193374
NCT01193374已完成不适用

Promoting Healthy Families Through Enhanced Primary Care

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
4
主要终点
BMI z score

研究概览

简要总结

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.

详细描述

  1. 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
  2. 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.
  3. 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.
  4. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Families with children ages 4 to 11 years
  • For post visit supports; Children > 85% for age BMI

排除标准

  • 未提供

结局指标

主要结局

BMI z score

时间窗: 6 months

Prevention of increase in BMI

次要结局

  • Parental readiness to initiate change(immediately post well visit)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (4)

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