South Texas Early Prevention Studies PreK (STEPSPreK)
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPS-PreK
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring Prek children, obesity prevalence
Eligibility Criteria
Inclusion Criteria:
- PreK children
- Enrolled in PSJA and La Joya ISDs
Exclusion Criteria:
- na
Sites / Locations
- University of Texas Rio Grande Valley
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
This group received health education, P.E. classes, child nutritional services, as well as a parent component.
This group received their usual health education and P.E. classes.
Outcomes
Primary Outcome Measures
cardiorespiratory fitness
as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test
Secondary Outcome Measures
Full Information
NCT ID
NCT05501392
First Posted
August 8, 2022
Last Updated
August 12, 2022
Sponsor
University of Texas Rio Grande Valley
Collaborators
Department of Health and Human Services
1. Study Identification
Unique Protocol Identification Number
NCT05501392
Brief Title
South Texas Early Prevention Studies PreK
Acronym
STEPSPreK
Official Title
South Texas Early Prevention Studies - PreK
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Rio Grande Valley
Collaborators
Department of Health and Human Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Prek children, obesity prevalence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
There were three sequential data collection periods through the process.
Masking
Outcomes Assessor
Masking Description
Outcome assessors were blinded to study design.
Allocation
Randomized
Enrollment
1277 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group received health education, P.E. classes, child nutritional services, as well as a parent component.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group received their usual health education and P.E. classes.
Intervention Type
Behavioral
Intervention Name(s)
STEPS-PreK
Intervention Description
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 Outcome Measure Information:
Title
cardiorespiratory fitness
Description
as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
PreK children
Enrolled in PSJA and La Joya ISDs
Exclusion Criteria:
na
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Alanis, Masters
Organizational Affiliation
University of Texas Rio Grande Valley
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Rio Grande Valley
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only aggregated data will be shared
Citations:
PubMed Identifier
33289119
Citation
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.
Results Reference
background
Links:
URL
https://www.utrgv.edu/stepsprek/
Description
Website for STEPS PreK project protocol especially parental outreach newsletters and consent forms (English and Spanish).
Learn more about this trial
South Texas Early Prevention Studies PreK
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