Primordial Prevention of Overweight in American Indian Children
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
- 是
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)
