South Texas Early Prevention Studies PreK

NCT05501392 | Completed DMC

• 1 other identifier: STEPS
• Study Type: interventional
• Target: 1,277
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Prek children; obesity prevalence

Outcome Measures

Primary Outcomes (1)

• cardiorespiratory fitness

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

  1.5 years

Study Arms (2)

Intervention

EXPERIMENTAL

This group received health education, P.E. classes, child nutritional services, as well as a parent component.

Behavioral: STEPS-PreK

Control

ACTIVE COMPARATOR

This group received their usual health education and P.E. classes.

Behavioral: STEPS-PreK

Interventions

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).

Control; Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• PreK children
• Enrolled in PSJA and La Joya ISDs

Sponsors & Collaborators

• University of Texas Rio Grande Valley: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

University of Texas Rio Grande Valley

Edinburg, Texas, 78539, United States

Location

Related Publications (2)

• Trevino-Pena 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. Online ahead of print.

  PMID: 33289119 BACKGROUND

• Trevino-Pena R, Romero Z, Fuentes JC, Cortez KE, Alanis E, Alvarenga JCL. A Coordinated School Health Program Effect on Cardiorespiratory Fitness of South Texas Preschool Children: A Cluster Randomized Trial. J Sch Health. 2024 Apr;94(4):336-345. doi: 10.1111/josh.13414. Epub 2024 Jan 22.

  PMID: 38252805 DERIVED

Related Links

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

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth Alanis, Masters

  University of Texas Rio Grande Valley

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to study design.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There were three sequential data collection periods through the process.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 15, 2022
• Study Start: September 28, 2018
• Primary Completion: March 17, 2020
• Study Completion: June 30, 2020
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)