Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 9:28 AM
Study NCT ID:
NCT05501392
Status:
COMPLETED
Last Update Posted:
2022-08-16
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
South Texas Early Prevention Studies PreK
Sponsor:
University of Texas Rio Grande Valley
Organization:
Study Overview
Official Title:
South Texas Early Prevention Studies - PreK
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPSPreK
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: