跳至主要内容
临床试验/NCT00245180
NCT00245180已完成不适用

Primordial Prevention of Overweight in American Indian Children

Kaiser Permanente0 个研究点目标入组 577 人开始时间: 2006年5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
577
主要终点
BMI

研究概览

简要总结

The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.

详细描述

BACKGROUND:

AI/AN children have overweight rates that are 18 to 30 percent higher than the general American population of children. Adult obesity has early antecedents, and data show that eating and physical activity behaviors are formed and set as early as 3 years of age, through primary socialization within families. Yet there are few, if any, obesity prevention programs that target children younger than 3 years of age.

DESIGN NARRATIVE:

This is a community-partnered randomized study to prevent early childhood overweight in AI/AN children. A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control (3 communities) or intervention condition (3 communities). The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers. Nutrition goals are to increase breastfeeding initiation and sustainability, limit sugared beverages for infants and toddlers, and make healthful choices during weaning and solid food introduction. Physical activity goals include promoting motor development, limiting video/TV viewing, and creating play opportunities for infants and toddlers. Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the intervention's feeding and physical activity components. Each component in the community-wide interventions will be collaboratively designed with the tribes, and tailored to each community's needs. Trained peer counselors will deliver the family interventions, during a series of 12 cluster visits, each covering a different developmental stage of the infant/toddler.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Women who have had uncomplicated pregnancies
  • Women who agree to have their child enrolled in the study and followed for 30 months
  • Women who are not planning to leave their area within 2 years of study start

排除标准

  • Women whose children have a serious illness known to affect normal growth

结局指标

主要结局

BMI

时间窗: birth, 6,12,18, and 24 months

次要结局

  • feeding(0-24 months)

研究者

申办方类型
Other
责任方
Sponsor

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