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临床试验/NCT00241878
NCT00241878已完成不适用

Preschool Based Obesity Prevention Effectiveness Trial

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点目标入组 648 人开始时间: 2006年9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
648
主要终点
Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)

研究概览

简要总结

The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.

详细描述

BACKGROUND:

Obesity is epidemic in the U.S. and is associated with increased risk for numerous medical problems. Many obesity-related risk factors are strikingly apparent in minority populations. Ethnic differences in obesity related risk factors begin as early as six to nine years of age. Thus, the need for overweight prevention efforts as early as the preschool years is critical.

This study builds upon the findings of the "Hip-Hop to Health" program. The primary aim of Hip-Hop was to compare changes in body mass index (BMI [kg/m2]) in two groups of 3- to 5-year-old minority children randomized to a Weight Control Intervention (WCI) or a General Health Control Intervention (GHI). Results for the children at the Year 1 and 2 follow-ups showed that children in the WCI had significantly smaller relative changes in BMI compared to children in the GHI control group. The success was among the schools that served predominantly Black children. Hip-Hop to Health was an efficacy trial delivered by trained specialists in early childhood education, and the first efficacy trial to document change in BMI in preschool children.

DESIGN NARRATIVE:

This study will test a 14-week teacher-delivered weight control intervention (TD-WCI) to a 14-week teacher delivered general health control intervention (TD-GHI) in a randomized community trial occurring in 16 preschools in the Chicago School District. The study has the following aims: 1) to compare children in these two conditions on changes in BMI post intervention and at Year 1 follow-up; 2) to compare children in these two conditions on changes in television viewing, physical activity, and fat, fiber, fruit and vegetable intake at post-intervention and Year 1 follow-up; and 3) to compare classroom teachers in these two conditions on nutrition and exercise knowledge, nutrition attitudes, and support for healthy eating post-intervention and Year 1 follow-up.

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
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Have received an annual physical
  • Parent or guardian willing to give informed consent
  • Parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

排除标准

  • Requires a specialized diet outside of that served by the Chicago Public Schools
  • Has a chronic physical or behavioral disorder that requires participant to be under close medical psychological supervision and routinely absent from the study

结局指标

主要结局

Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)

时间窗: Sept 2006- May 2009

Score on Nutrition Attitudes Scale

时间窗: Sept 2006- May 2009

Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit)

时间窗: Sept 2006- May 2009

24-hour diet observation and recall

时间窗: Sept 2006- May 2009

Self-efficacy for eating and exercise behaviors

时间窗: Sept 2006- May 2009

Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit)

时间窗: Sept 2006- May 2009

Physical activity

时间窗: Sept 2006- May 2009

Nutrition and exercise knowledge

时间窗: Sept 2006- May 2009

Body height and weight

时间窗: Sept 2006- May 2009

Healthy Start Knowledge Quiz

时间窗: Sept 2006- May 2009

次要结局

未报告次要终点

研究者

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