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临床试验/NCT05501392
NCT05501392已完成不适用

South Texas Early Prevention Studies - PreK

University of Texas Rio Grande Valley2 个研究点 分布在 1 个国家目标入组 1,277 人开始时间: 2018年9月28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
1,277
试验地点
2
主要终点
cardiorespiratory fitness

研究概览

简要总结

The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.

详细描述

The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit of randomization, intervention, and analysis. The study was designed for two years of intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring 2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped prematurely and only results from the first three periods will be presented.

The two school districts where the study was conducted are located along the Texas-Mexico border in the county of Hidalgo. These school districts were selected because of the high poverty and health risk-factors levels.25 The preschools have two grade levels with children 3 and 4 years of age. The present study targeted preschools with children 4 years of age. Demographics of the two school districts were similar, 99% Hispanic, 92% economically disadvantaged, and 42% identified as English as a second language.

研究设计

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

盲法说明

Outcome assessors were blinded to study design.

入排标准

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

入选标准

  • PreK children
  • Enrolled in PSJA and La Joya ISDs

排除标准

  • 未提供

结局指标

主要结局

cardiorespiratory fitness

时间窗: 1.5 years

as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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