BN CSHP for Child Health Behaviors

(STEPSSNAP-Ed Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Rio Grande Valley

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce obesity rates in preschool children in South Texas by promoting healthier eating and physical activity. The study will implement the Bienestar/Neema Coordinated School Health Program (BN CSHP), a school health curriculum approved in Texas. Participants will either join this program or continue their regular activities as a control group. The trial seeks PreK 4 students enrolled in participating South Texas school districts. As an unphased trial, it offers families a unique opportunity to contribute to important research that could enhance children's health and well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BN CSHP is safe for children?

Research has shown that the Bienestar/Neema Coordinated School Health Program (BN CSHP) has been tested with children before. The program aims to improve nutrition and physical activity, both crucial for preventing obesity. Studies have examined the program's impact on children's health, particularly their cardiovascular and respiratory fitness during exercise. These studies found no serious safety issues or negative effects for the children involved, suggesting the program is safe and well-tolerated. As always, those considering participation should discuss any concerns with the trial team or a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bienestar/Neema Coordinated School Health Program (BN CSHP) because it offers a comprehensive approach to improving child health behaviors, differentiating itself from standard methods that often address only one aspect, like diet or physical activity. Unlike typical programs, BN CSHP is a multi-pronged intervention approved by the Texas Education Agency, integrating health education directly into school curricula alongside activities and parental engagement. This holistic strategy aims to create a supportive environment for lasting behavior changes, making it a promising alternative to conventional single-focus interventions.

What evidence suggests that the BN CSHP is effective for controlling and preventing obesity in children?

Research has shown that the Bienestar/Neema Coordinated School Health Program (BN CSHP), provided to participants in the intervention arm of this trial, positively impacts children's health habits. Studies found that children in the BN CSHP improved their heart and lung health more than those not in the program, indicating better overall fitness. The program teaches kids to make healthier food choices and encourages them to be more active. These findings suggest that BN CSHP helps children lead healthier lives and aims to prevent obesity. ^{1 2 4 5 6}

Who Is on the Research Team?

Zasha Romero, Ph.D.

Principal Investigator

University of Texas Rio Grande Valley

Are You a Good Fit for This Trial?

The STEPS SNAP-Ed trial is for PreK 4 students enrolled in participating school districts in South Texas. It aims to help children from low-income families, those eligible for SNAP or Medicaid, and schools where many kids get free or reduced meals.

Inclusion Criteria

My child is enrolled in PreK 4 in a participating school district.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Bienestar/Neema Coordinated School Health Program, focusing on nutrition education and physical activity

3 years

Ongoing school-based activities

Follow-up

Participants are monitored for changes in obesity prevalence, fitness scores, and dietary intake

3 years

Regular assessments throughout the intervention period

What Are the Treatments Tested in This Trial?

Interventions

• Bienestar/Neema Coordinated School Health Program (BN CSHP)

Trial Overview This trial tests the Bienestar/Neema Coordinated School Health Program (BN CSHP), which promotes better nutrition and physical activity to prevent obesity in preschoolers through community engagement involving parents, school and hospital staff.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas Rio Grande Valley

Lead Sponsor

Trials

8

Recruited

2,700+

Pharr-San Juan-Alamo Independent School District

Collaborator

Trials

1

Recruited

1,100+

Health and Human Services Commission (HHSC)

Collaborator

Trials

1

Recruited

1,100+

La Joya Independent School District

Collaborator

Trials

1

Recruited

1,100+

Texas Health and Human Services

Collaborator

Trials

1

Recruited

1,100+

Pharr, San Juan, Alamo School District

Collaborator

Trials

1

Recruited

1,100+

La Jolla Independent School District

Collaborator

Trials

1

Recruited

1,100+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38252805/

A Coordinated School Health Program Effect on ... Background: The purpose of this study was to assess the effects of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on cardiorespiratory ...

2. utrgv.edu utrgv.edu/steps/_files/documents/publications/a-coordinated-school-health-program-effect-on-cardiorespiratory-fitness-publishing.pdf

a-coordinated-school-health-program-effect-on- ... BACKGROUND: The purpose of this study was to assess the effects of the Bienestar/NEEMA Coordinated School Health. Program (BN CSHP) on cardiorespiratory fitness ...

3. withpower.com withpower.com/trial/phase-health-related-behavior-7-2022-01c05

BN CSHP for Child Health Behaviors (STEPSSNAP-Ed Trial) What data supports the effectiveness of the treatment Bienestar/Neema Coordinated School Health Program (BN CSHP) for improving child health behaviors? Research ...

4. eric.ed.gov eric.ed.gov/?q=Health+AND+benefits&ff1=souJournal+of+School+Health

ERIC - Search Results BACKGROUND: The purpose of this study was to assess the effects of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on ...

5. researchgate.net researchgate.net/publication/377596384_A_Coordinated_School_Health_Program_Effect_on_Cardiorespiratory_Fitness_of_South_Texas_Preschool_Children_A_Cluster_Randomized_Trial

A Coordinated School Health Program Effect on ... CONCLUSION Children in the BN CSHP, compared to those in the control group, had a significantly higher increase in their CRF. This finding is ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05501392?term=AREA%5BBasicSearch%5D(texas)&rank=7&checkSpell=

NCT05501392 | South Texas Early Prevention Studies PreK 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 ...