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临床试验/NCT03321071
NCT03321071已完成1 期

Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.

University of South Carolina2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
180
试验地点
2
主要终点
Change in Body Mass Index (BMI) Z-score

研究概览

简要总结

Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. This work represents an important step towards addressing important public health goals - obesity and learning - through a comprehensive program delivered during a timeframe - summer vacation - where substantial and long-lasting negative effects occur.

详细描述

Summer vacation represents an important time away from the school setting for a majority of children attending public school in the US. This break is characterized by large amounts of free time and involvement in a wide variety of formal and informal activities, time spent with friends and family, and travel. Yet for many children, particularly those from low-income households, summer vacation represents a "window of vulnerability" in which dramatic declines in both health and academics occur. During the summer months (typically 3 months) children gain a larger amount of body weight compared to the amount of weight gained over the school year, and weight gain during summer reverses weight losses achieved during school. For academics, it is well established that children from low-income households experience greater declines in reading and math during the summer than their middle-to-upper income peers. Numerous programs that address these issues currently exist (e.g., summer school, summer weight loss or fitness programs). However, these programs are designed and delivered at the expense of the promotion or prevention of the other - academic focus without health or health focus without academics. Our long-term goal is to develop summer programming for widespread dissemination that addresses both lifestyle behaviors (i.e., physical activity and nutrition) and academic performance. The objective of the proposed study is to establish the effectiveness of an innovative "Healthy Summer Learners" (HSL) program for low-income, minority children. The rationale for the proposed research is that no summer programs incorporate curriculum that addresses both unhealthy weight gains and academic achievement simultaneously. This study seeks to fill this void by testing a prototype learning and health-oriented summer program focused on promoting physical activity and nutrition, along with content that provides quality learning experiences to develop reading and math skills. To accomplish this objective, this study will evaluate over 2 summers the effectiveness of a 6-week Healthy Summer Learners program delivered within a Boys & Girls Club summer camp using a randomized design in a sample of rising 2nd, 3rd, and 4th graders. The aims of the study are Aim 1: Evaluate the impact of Healthy Summer Learners on children's weight gain and academic performance from beginning (end of Spring school year) to the end of summer (beginning of Fall school year), and Aim 2: Evaluate the feasibility and acceptability of Healthy Summer Learners to children, parents, and program staff.

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
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • MAP scores are norm referenced based on typical grade level scores. Students that have scored between the 25th and 75th percentile will be eligible to participate in the study.

排除标准

  • children with severe intellectual or physical disabilities

结局指标

主要结局

Change in Body Mass Index (BMI) Z-score

时间窗: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL

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

Change in Measures of Academic Progress Reading Scores

时间窗: MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL

Measure Description: Created by the Northwest Evaluation Association (www.nwea.org), MAP results are widely accepted and used extensively in school-aged children. Scores are reported using the Rasch Unit Scale, a curriculum scale developed using Item Response Theory that estimates student achievement. The Rasch Unit Scale ranges from 140-300 and are norm referenced based on grade. Higher scores indicate better reading profeciency.

次要结局

  • Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program(Sedentary time will be collected daily from baseline to 12 weeks)
  • Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program(Screen time will be collected twice weekly from baseline to 12 weeks)
  • Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program(Diet will be collected twice weekly from baseline to 12 weeks)
  • Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program(Sleep will be collected daily from baseline to 12 weeks)
  • Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program(Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks)
  • Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.(Sleep onset will be collected daily from baseline to 12 weeks)
  • Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program(Sleep offset will be collected daily from baseline to 12 weeks)
  • Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program(Sleep midpoint will be collected daily from baseline to 12 weeks)

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)

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