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临床试验/NCT00377767
NCT00377767Unknown1 期

Improving Primary Care to Prevent Childhood Obesity

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2006年9月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
500
试验地点
1
主要终点
Body mass index (BMI) at 1 year.

研究概览

简要总结

To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.

详细描述

Overweight in the preschool age group is prevalent, increasing, and of consequence. During the last 30 years in the U.S., the prevalence of overweight among youth has dramatically increased. Overweight in young children is associated with later overweight, with childhood conditions such as hyperlipidemia, hypertension, and type II diabetes, and with higher morbidity and mortality in adulthood.

Along with the long-term risks associated with overweight in the preschool age group, there come unique opportunities to intervene and alter the subsequent course of health and disease for these individuals. These regular visits allow both detection of elevated BMI levels and opportunities for intervention.

The overall goal of this research is to assess a comprehensive, innovative, primary care practice change intervention to prevent obesity among children age 2 through 5 years at elevated risk of obesity. To achieve this goal, we will conduct a cluster-randomized controlled trial in 10 pediatric practices of Harvard Vanguard Medical Associates, a large multi-site group practice in eastern Massachusetts with a track record of research collaboration.

We will randomize five health centers to the intervention condition, and five health centers to the control (usual care) condition. The intervention will consist of state-of-the-science approaches to changing dietary, activity, and inactivity behaviors among the children.

The intervention period will be 1 year, followed by a 1 1/2 year maintenance follow-up period. Frequency of visits will be every 6 weeks for the first 6 months, and every 6 months after that. Participating families will complete a telephone-administered interview at baseline and all follow-up timepoints. There will be 3 types of measurements: 1) measurements made by the clinical staff that will also be used for outcomes in the research study (only height and weight); 2) measurements made by clinicians for feedback during counseling sessions, which will not be used for study outcomes; and 3) measurements made by the research staff for study outcomes and processes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 2.0 through 5.9 years receiving primary care in a multi-site group practice
  • BMI > 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight

排除标准

  • Child currently enrolled in a formal weight management program
  • Child is in foster care
  • Chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations

结局指标

主要结局

Body mass index (BMI) at 1 year.

次要结局

  • Sugar-sweetened beverages intake at 1 year post intervention.
  • Television viewing behaviors at 1 year post intervention.
  • Fast food intake at 1 year post intervention.

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 (1)

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