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临床试验/NCT04189926
NCT04189926已完成不适用

Physical Activity, Sedentary Behavior and Weight Status in Early Childhood

University of South Carolina1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Total daily physical activity

研究概览

简要总结

Leading health organizations have identified prevention of obesity in young children as a critical public health challenge. Low levels of physical activity and high levels of sedentary behavior may contribute to the development of excessive fatness in young children, but these relationships have not been fully explored, and accelerometry rarely has been used to measure physical activity levels in infants and toddlers. No previous study has used accelerometry as an objective measure of physical activity in young children as they develop from infancy to preschool age. Accordingly, little is known about the factors associated with the development of physical activity behavior in very young children, and little is known about the influence of physical activity and sedentary behavior, measured objectively, on development of weight status during the transition from infancy to age 3. The first aim of this study is to describe physical activity and sedentary behavior in young children as they develop from infancy to preschool age. The second aim is to describe the longitudinal associations of weight status with physical activity and sedentary behavior as young children develop from infancy to preschool age. The proposed investigation will employ a longitudinal, observational study design. Participants will be 160 children and their biological mothers living in Columbia, South Carolina. For each participating child, measurements will be taken at 6, 12, 18, 24, 30, and 36 months of age. At each time point, each child's physical activity, sedentary behavior, weight status and motor developmental status will be measured objectively, and each child's mother will complete a survey to assess demographic, social and physical environmental factors; gross motor milestones; parenting practices related to physical activity and sedentary behavior; and dietary practices. Childcare center directors will complete a survey annually to assess center characteristics, and the Environment and Policy Assessment and Observation (EPAO) will be administered in the child's classroom annually.

详细描述

Subjects and Settings. The proposed research will be conducted in Columbia/Richland County, South Carolina (SC). Participants will be 160 children and their biological mothers. Children of all races and ethnic backgrounds will be included. Our recruitment procedures will be designed to produce a sample with the following approximate race/ethnicity distribution: 38% non-Hispanic African American, 38% non-Hispanic White, 20% Hispanic, and 4% other. Further, we anticipate that approximately two-thirds of the participating children be attending formal childcare centers and one-third will be at home or staying with a family member. Equal percentages of female and male children will be included. Children will be excluded from the study if they were born before 37 weeks gestation or have a physical limitation that would invalidate accelerometry as a measure of physical activity.

Recruitment of Participants. Participants in the study will be 160 mother-child dyads who will be recruited into the study when the children are between 3 and 6 months of age. They will be residents of Richland County, South Carolina. Recruitment will take place across a 9-month period and will be designed to recruit two cohorts of 80 children each. Baseline data collection will occur when each child is within one month of being 6 months of age. The recruitment process will be coordinated by Richland County First Steps (RCFS), a non-profit organization founded in 1999 to support provision of quality early childhood education for children ages 0 to 5 in Richland County.

One-third of participants will be mother-child dyads from families in which the child does not attend a formal childcare center. Richland County First Steps, in addition to its work with childcare centers, delivers programs directly to families of young children, including Latino families.

Cohort Maintenance. Participating mothers and children will be retained in the study across a 30-month period of observation by maintaining excellent communication with the parents and, for children attending formal childcare centers, the directors and staff of the childcare centers they attend. The process of maintaining excellent relationships with parents and center staff will be coordinated by RCFS and managed collaboratively with the University-based study staff.

Measures

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 6-36 months and their biological mothers, recruited from childcare centers and families in the greater Columbia, SC area

排除标准

  • Children born prior to 37 weeks gestation or who have a physical limitation that would invalidate accelerometry as a measure of physical activity

结局指标

主要结局

Total daily physical activity

时间窗: Every 6 months, ages 6-36 months

Average accelerometer counts per minute

Sedentary behavior

时间窗: Every 6 months, ages 6-36 months

Average accelerometer counts per minute below the light PA cutpoint

Weight status

时间窗: Every 6 months, ages 6-36 months

Weight in kg

Dietary behavior

时间窗: Every 6 months, ages 6-36 months

ECLS-B and other parent report instruments

Total physical activity

时间窗: Every 6 months, ages 6-36 months

Average accelerometer counts per minute above the light PA cutpoint

Sleep

时间窗: Every 6 months, ages 6-36 months

Sleep behavior measured by actigraph, measured in 50% of participants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Russell Pate

Professor

University of South Carolina

研究点 (1)

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