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Completed

NCT Number: NCT05501392

South Texas Early Prevention Studies PreK

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Rio Grande Valley

Edinburg, Texas, 78539, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PreK children
  • Enrolled in PSJA and La Joya ISDs

Exclusion criteria

  • na

Treatment and study plan

STEPS-PreK

Behavioral

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).

Primary outcomes

  1. cardiorespiratory fitness

    Time frame: 1.5 years

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

Sponsors and collaborators

Lead sponsor

University of Texas Rio Grande Valley

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

South Texas Early Prevention Studies - PreK

Acronym: STEPSPreK

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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