Health-Related BehaviorSTEPSSNAP-EdNCT05851144
South Texas Early Prevention Studies SNAP-Ed (STEPS SNAP-Ed)
A study testing Bienestar/Neema Coordinated School Health Program (BN CSHP) in people with Health-Related Behavior, run by University of Texas Rio Grande Valley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-Related Behavior
- What is being tested?
- Bienestar/Neema Coordinated School Health Program (BN CSHP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All enrolled PreK 4 students to participating school districts
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Rio Grande Valley
Edinburg, Texas, 78539
About this study
Official title: South Texas Early Prevention Studies SNAP-Ed
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.
Read the 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 Dietary Guidelines for Americans 2015-2020 8th Edition.
State Goal V: Increase ongoing physical activity among the SNAP-Ed Target Audience in accordance with Physical Activity Guidelines 2nd Edition. State Goal VI: Increase Policy, Systems, and Environmental (PSE) projects consistent with Fiscal Year 2021 SNAP-Ed Plan Guidance.
Specifically, the primary and secondary outcomes are the following:
II.a. Primary Outcome - Obesity Prevalence
- 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
- Significantly increase fitness scores of children in intervention schools compared to those in control schools over the 3-year intervention period.
- 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
- 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.
- 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.
- 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.
- Process Evaluation Measures.
- Dose (lesson plan taught) \& reach (number of participants in attendance) and submitted into PEARS software.
- SNAP Ed long-term, mid-term and short-term survey instruments will be submitted into PEARS software.
- Conditions
- Health-Related Behavior
- Being tested
- Bienestar/Neema Coordinated School Health Program (BN CSHP)
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bienestar/Neema Coordinated School Health Program (BN CSHP)Behavioural
Bienestar/Neema Coordinated School Health Program (BN CSHP), a Texas Education Agency-approved school health curricula, is a multi-prong intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Bienestar/Neema Coordinated School Health Program (BN CSHP) |
| Control | No intervention | Participants in the control group follow regular routine with physical activities, food service, and parental engagment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A rate of 5% decrease in BMI
Number of participants in the intervention schools, as compared to the control schools, will demonstrate a 5% decrease at the rate of childhood obesity as measured by the BMI>=95 Percentile
Measured: 3 years
Secondary outcomes (2)
Fruits/vegetables/whole grains consumption increase at a rate of 5% increase in servings
The number of fruits/vegetables/whole grains consumption increase in servings at a rate of 5%
Measured: 3 years
A rate of 5% Increase of pacer laps run as measured by laps recorded
A rate of 5% Increase of pacer laps run as measured by laps recorded
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start31 Aug 2022
- Primary completion31 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- School-based approach is used to complete the randomized assignment to intervention or control conditions.
- Masking
- None (open label)
- Enrolment
- 1,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Rio Grande Valley
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Human Services Commission (HHSC), Pharr-San Juan-Alamo Independent School District, La Joya Independent School District
- Responsible party
- Sponsor
- Investigators
- Zasha Romero, Ph.D., Principal investigator, University of Texas Rio Grande Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851144
- Sponsor's protocol ID
- STEPS SNAP-Ed
- Acronym
- STEPSSNAP-Ed
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Texas Early Prevention Studies SNAP-Ed
- ClinicalTrials.gov ID
- NCT05851144
- Acronym / sponsor ID
- STEPSSNAP-Ed / STEPS SNAP-Ed
- Conditions
- Health-Related Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,104 participants (actual)
- Lead sponsor
- University of Texas Rio Grande ValleyUniversity, hospital or other
- Collaborators
- Health and Human Services Commission (HHSC), Pharr-San Juan-Alamo Independent School District, La Joya Independent School District
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Dietary Guidelines for Americans 2015-2020 8th Edition.
State Goal V: Increase ongoing physical activity among the SNAP-Ed Target Audience in accordance with Physical Activity Guidelines 2nd Edition. State Goal VI: Increase Policy, Systems, and Environmental (PSE) projects consistent with Fiscal Year 2021 SNAP-Ed Plan Guidance.
Specifically, the primary and secondary outcomes are the following:
II.a. Primary Outcome - Obesity Prevalence
- 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
- Significantly increase fitness scores of children in intervention schools compared to those in control schools over the 3-year intervention period.
- 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
- 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.
- 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.
- 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.
- Process Evaluation Measures.
- Dose (lesson plan taught) \& reach (number of participants in attendance) and submitted into PEARS software.
- SNAP Ed long-term, mid-term and short-term survey instruments will be submitted into PEARS software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- School-based approach is used to complete the randomized assignment to intervention or control conditions.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Bienestar/Neema Coordinated School Health Program (BN CSHP)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. |
| Control | No intervention | –Participants in the control group follow regular routine with physical activities, food service, and parental engagment. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All enrolled PreK 4 students to participating school districts
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Intervention |
Primary outcome
A rate of 5% decrease in BMI
Time frame: 3 years
Number of participants in the intervention schools, as compared to the control schools, will demonstrate a 5% decrease at the rate of childhood obesity as measured by the BMI>=95 Percentile
2 secondary outcomes
Fruits/vegetables/whole grains consumption increase at a rate of 5% increase in servings
Time frame: 3 years
A rate of 5% Increase of pacer laps run as measured by laps recorded
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. Only aggregated data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zasha Romero, Ph.D. principal investigator
University of Texas Rio Grande Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bienestar/Neema Coordinated School Health Program (BN CSHP) in people with Health-Related Behavior, run by University of Texas Rio Grande Valley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A rate of 5% decrease in BMI (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.