South Texas Early Prevention Studies PreK

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: STEPS-PreK

• Registration Number: NCT05501392
• Lead Sponsor: University of Texas Rio Grande Valley

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.

Study Timeline

• Study Start: 2018-09-28
• Primary Completion: 2020-03-17
• Study Completion: 2020-06-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-11
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1277

Inclusion Criteria

• PreK children
• Enrolled in PSJA and La Joya ISDs

Exclusion Criteria

• na

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control	STEPS-PreK	This group received their usual health education and P.E. classes.
Intervention	STEPS-PreK	This group received health education, P.E. classes, child nutritional services, as well as a parent component.

Primary Outcome Measures

Name	Time	Method
cardiorespiratory fitness	1.5 years	as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test

Trial Locations

Locations (1)

University of Texas Rio Grande Valley; 🇺🇸 Edinburg, Texas, United States