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South Texas Early Prevention Studies PreK

South Texas Early Prevention Studies - PreK

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05501392
Acronym
STEPSPreK
Enrollment
1277
Registered
2022-08-15
Start date
2018-09-28
Completion date
2020-06-30
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

Prek children, obesity prevalence

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.

Interventions

BEHAVIORALSTEPS-PreK

Intervention group received the BN CHSP, a Texas Education Agency (TEA)-approved CSHP. This health program was first piloted in schools located in low-income neighborhoods where enrollment was predominantly Black and Latino children. The Social-Ecological Model guided the BN CSHP design. This theory postulates that health behaviors are molded by individual, interpersonal, and environmental interactions. Thus, BN CSHP encompasses curricula from preschool to eighth grade and is designed to target the four environments that influence children's health behaviors: 1) Healthy Lifestyles Healthy Minds (Health), 2) Moving For Life (Physical Education), 3) Eat to Live (Child Nutrition/School Food Service), and 4) MyFamily/MiFamilia (Home).

Sponsors

Department of Health and Human Services
CollaboratorFED
University of Texas Rio Grande Valley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors were blinded to study design.

Intervention model description

There were three sequential data collection periods through the process.

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* PreK children * Enrolled in PSJA and La Joya ISDs

Exclusion criteria

* na

Design outcomes

Primary

MeasureTime frameDescription
cardiorespiratory fitness1.5 yearsas measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026