South Texas Early Prevention Studies PreK

Childhood Obesity Clinical Trial

— STEPSPreK  

Official title:

South Texas Early Prevention Studies - PreK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501392
• Other study ID #: STEPS
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2022
• Source: University of Texas Rio Grande Valley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1277
• Est. completion date: June 30, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

• PreK children

• Enrolled in PSJA and La Joya ISDs

Exclusion Criteria:

• na

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• STEPS-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).

Locations

Country	Name	City	State
United States	University of Texas Rio Grande Valley	Edinburg	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Rio Grande Valley	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

Treviño-Peña R, Wang X, Wang L, Romero Z, Alanis E, Li H. Social and Health Risk Factor Levels of Preschool Children Living Along the Texas-Mexico Border. J Sch Health. 2020 Dec 2. doi: 10.1111/josh.12979. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiorespiratory fitness	as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test	1.5 years

External Links

•   Website for STEPS PreK project protocol especially parental outreach newsletters and consent forms (English and Spanish).