跳至主要内容
临床试验/NCT04608188
NCT04608188已完成不适用

An Intervention to Prevent Weight Gain and Unhealthy Behaviors in Children From Economically Disadvantaged Circumstances

University of South Carolina2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年11月15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
89
试验地点
2
主要终点
Change in Body Mass Index Z-score

研究概览

简要总结

This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.

详细描述

Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • participants will be boys and girls that attend one of the participating schools
  • indicates "yes' on an informed consent document for participation in the study

排除标准

  • diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
  • children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study.
  • No other exclusion criteria will be used.

结局指标

主要结局

Change in Body Mass Index Z-score

时间窗: End of school year (start of summer - baseline), beginning of the following school year (3 month)

Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity. Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese

次要结局

  • Change in Monitor BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))
  • Change in Inhibit BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))
  • Change in Emotional Control BRIEF Subscale(End of school year (start of summer - baseline), beginning of the following school year (3 month))

研究者

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

R. Glenn Weaver

Assistant Professor

University of South Carolina

研究点 (2)

Loading locations...

相似试验