STEPSSNAP-Ed: South Texas Early Prevention Studies SNAP-Ed (STEPS SNAP-Ed)

Sponsor
University of Texas Rio Grande Valley (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05851144
Collaborator
Texas Health and Human Services (Other), Pharr, San Juan, Alamo School District (Other), La Jolla Independent School District (Other)
1,104
1
2
37
29.8

Study Details

Study Description

Brief Summary

The "South Texas Early Prevention Studies Supplemental Nutrition Assistance Program-Education" (STEPS SNAP-Ed) is a project designed to control and prevent obesity rates in South Texas children. The University of Texas Rio Grande Valley (UTRGV) was awarded funding from the Texas Health and Human Services Commission (HHSC) to provide behaviorally focused, evidence-based nutrition education and obesity prevention interventions to serve the South Texas SNAP-Ed target audience. The SNAP-Ed target audience are SNAP-Ed recipients, SNAP eligible, communities with ≥50% low-income, schools where ≥50% of children are on free and reduced meals, and those on Medicaid. Specifically, the STEPS SNAP-Ed Project will engage parents, school staff, hospital staff and community members to make healthier food choices available and encourage physical activity to control and prevent obesity in preschool children. The STEPS SNAP-Ed Project is a collaborative effort among a university, two school districts, and a hospital system in the Rio Grande Valley.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bienestar/Neema Coordinated School Health Program (BN CSHP)
N/A

Detailed Description

The STEPS SNAP-Ed project aim is to meet the United States Department of Agriculture's (USDA) Food and Nutrition Service (FNS) requirements through the following Texas SNAP-Ed State

Goals:

State Goal I: Implement health promotion activities to help the SNAP-Ed Target Audience establishes healthy eating habits and a physically active lifestyle. State Goal II: Reduce risk factors for chronic diseases such as obesity, type 2 diabetes, and cardiovascular disease among the SNAP-Ed Target Audience. State Goal III: Increase partnership collaboration of nutrition, physical activity, and wellness education across the state.

State Goal IV: Increase consumption of fruits, vegetables, and other foods that comprise a healthy diet among the SNAP-Ed Target Audience in accordance with Appendix B, Dietary Guidelines for Americans 2015-2020 8th Edition (see original narrative proposal).

State Goal V: Increase ongoing physical activity among the SNAP-Ed Target Audience in accordance with Appendix C, Physical Activity Guidelines 2nd Edition (see original narrative proposal).

State Goal VI: Increase Policy, Systems, and Environmental (PSE) projects consistent with Appendix D, FY 2021 SNAP-Ed Plan Guidance (see original narrative proposal).

Specifically, the primary and secondary outcomes are the following:

II.a. Primary Outcome - Obesity Prevalence

  1. Decrease obesity prevalence by 5 percent in children from intervention schools compared to those in control schools over the 3-year intervention period.

II.b. Secondary Outcomes - Fitness and Dietary Intake

  1. Significantly increase fitness scores of children in intervention schools compared to those in control schools over the 3-year intervention period.

  2. Significantly increase the intake of fruits, vegetables, and whole grains servings in children from intervention schools compared to those in control schools over the 3-year intervention period.

II.c. Evaluation Plan - Summary

  1. BMI Measure. Obesity prevalence is measured by height (ht.), weight (wt.) and body mass index (BMI) calculated by (kg/m2). Obesity prevalence is defined by a BMI ≥ 95th percentile.

  2. Fitness Measure. Fitness test consists of the modified PACER test (15-meter distance, 20-meter cadence). It is modified because the PACER fitness test was designed to begin implementation in third grade. The PACER test involves running back and forth across a course to a cadence audio track played from a CD. Beeps in the track indicate when a child should reach the end point of a lap. The fitness test begins at a slow pace and it gets more difficult as the pace quickens. The child continues running until he/she fails to complete a lap by reaching the end point before the next beep on the meter cadence track. Once a child misses two laps (missed laps do not need to be consecutive) the PACER Test concludes, and the number of laps is recorded.

  3. Dietary Intake Measure. Dietary Intake of fruits, vegetables, and whole grains consumed during school breakfast and lunch will be measured by direct observation and supplemented by meal photographs (before and after meals are consumed). Dietary data will be collected over 3 consecutive days and consumption average will be calculated.

  4. Process Evaluation Measures.

  5. Dose (lesson plan taught) & reach (number of participants in attendance) and submitted into PEARS software.

  6. SNAP Ed long-term, mid-term and short-term survey instruments will be submitted into PEARS software.

Study Design

Study Type:
Interventional
Actual Enrollment :
1104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
School-based approach is used to complete the randomized assignment to intervention or control conditions.School-based approach is used to complete the randomized assignment to intervention or control conditions.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
South Texas Early Prevention Studies SNAP-Ed
Actual Study Start Date :
Aug 31, 2022
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Intervention arm involves participants to the Bienestar/Neema Coordinated School Health Program (BN CSHP), a Texas Education Agency-approved school health curricula with multi-prong interventions.

Behavioral: Bienestar/Neema Coordinated School Health Program (BN CSHP)
Bienestar/Neema Coordinated School Health Program (BN CSHP), a Texas Education Agency-approved school health curricula, is a multi-prong intervention

No Intervention: Control

Participants in the control group follow regular routine with physical activities, food service, and parental engagment.

Outcome Measures

Primary Outcome Measures

  1. 5% Decrease of childhood obesity [3 years]

    Children in intervention school demonstrate a 5% decrease in childhood obesity measured by BMI calculation

Secondary Outcome Measures

  1. 5% Increase of healthy dietary components [3 years]

    Children in intervention school have a 5% increase in total intake of healthy dietary components (i.e. fruits, vegetables, and whole grains)

  2. 5% Increase of pacer laps [3 years]

    Children in intervention school have a 5% increase in laps completed with a pacer test

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All enrolled PreK 4 students to participating school districts
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas Rio Grande Valley Edinburg Texas United States 78539

Sponsors and Collaborators

  • University of Texas Rio Grande Valley
  • Texas Health and Human Services
  • Pharr, San Juan, Alamo School District
  • La Jolla Independent School District

Investigators

  • Principal Investigator: Zasha Romero, Ph.D., University of Texas Rio Grande Valley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Texas Rio Grande Valley
ClinicalTrials.gov Identifier:
NCT05851144
Other Study ID Numbers:
  • STEPS SNAP-Ed
First Posted:
May 9, 2023
Last Update Posted:
May 9, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 9, 2023