- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05851144
South Texas Early Prevention Studies SNAP-Ed (STEPS SNAP-Ed) (STEPSSNAP-Ed)
South Texas Early Prevention Studies SNAP-Ed
Study Overview
Status
Conditions
Intervention / Treatment
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
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
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Edinburg, Texas, United States, 78539
- University of Texas Rio Grande Valley
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All enrolled PreK 4 students to participating school districts
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fruits/vegetables/whole grains consumption increase at a rate of 5% increase in servings
Time Frame: 3 years
|
The number of fruits/vegetables/whole grains consumption increase in servings at a rate of 5%
|
3 years
|
A rate of 5% Increase of pacer laps run as measured by laps recorded
Time Frame: 3 years
|
A rate of 5% Increase of pacer laps run as measured by laps recorded
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zasha Romero, Ph.D., University of Texas Rio Grande Valley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STEPS SNAP-Ed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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