School Programs for Youth Cardiovascular Health

(HSRC Trial)

Overseen By Jacob Szeszulski, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: Motor, cognitive impairments, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Enhanced Engagement, EngAGE, Enhanced Engagement, Motivational Enhancement Therapy, Enhanced Resources, Healthy School Recognized Campus Program, Enhanced School-Based Physical Activity and Nutrition Programs, Mentoring Program for youth cardiovascular health?

Research shows that school-based programs focusing on physical activity and nutrition can improve fitness and cardiovascular health in children. Programs like the Heart Smart Family Health Promotion Program have demonstrated positive changes in eating habits, physical activity, and blood pressure levels, suggesting that similar school-based interventions can be effective for cardiovascular risk reduction. ^{1 2 3 4 5}

Is the school-based cardiovascular health program safe for children?

The school-based cardiovascular health programs, such as Be a Fit Kid and the Know Your Body program, have been shown to be safe for children, leading to improvements in fitness, nutrition knowledge, and cardiovascular health without reported safety concerns. ^{4 6 7 8 9}

How is the EngAGE treatment different from other treatments for youth cardiovascular health?

The EngAGE treatment is unique because it combines enhanced engagement, resources, and mentoring with a focus on school-based physical activity and nutrition programs, creating a comprehensive approach that involves the entire school environment and family participation, unlike other treatments that may focus on singular interventions or specific behaviors. ^{4 8 10 11 12}

Research Team

Jacob Szeszulski, PhD

Principal Investigator

Texas A&M AgriLife

Eligibility Criteria

This trial is for public elementary schools in North and East Texas with students in the 5th or 6th grade. Students must be at least 10 years old by September 1, able to read, speak, and write English. There's no mention of specific exclusions.

Inclusion Criteria

You attended a public primary school.

You can understand and communicate in English.

I am currently a student.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Schools are randomized to receive different strategies to support the Healthy School Recognized Campus program implementation

9 months

Ongoing school-based activities

Follow-up

Participants are monitored for changes in cardiovascular risk factors and program effectiveness

4 weeks

Treatment Details

Interventions

• Enhanced Engagement
• Enhanced Resources
• Mentoring Program

Trial Overview The study tests a program called Healthy School Recognized Campus which includes mentoring, extra resources, and increased engagement to boost physical activity and nutrition among youth to lower their risk of heart disease.

Participant Groups

Group I: Mentoring Program Experimental Treatment 1 Intervention

Participants in this group will receive the Mentoring Program strategy in addition to Healthy School Recognized Campus.

Group II: Mentoring + Enhanced Resources + Enhanced Engagement Experimental Treatment 3 Interventions

Participants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Group III: Mentoring + Enhanced Resources Experimental Treatment 2 Interventions

Participants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus.

Group IV: Mentoring + Enhanced Engagement Experimental Treatment 2 Interventions

Participants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Group V: Enhanced Resources + Enhanced Engagement Experimental Treatment 2 Interventions

Participants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Group VI: Enhanced Resources Experimental Treatment 1 Intervention

Participants in this group will receive the Enhanced Resources strategy in addition to Healthy School Recognized Campus.

Group VII: Enhanced Engagement Experimental Treatment 1 Intervention

Participants in this group will receive the Enhanced Engagement strategy in addition to Healthy School Recognized Campus.

Group VIII: No Intervention Active Control 1 Intervention

All schools will participate in the HSRC initiative. The requirements for the initiative are to complete a school-wide walking program, 1 youth, and 1 adult program from a list of available programs that make up the initiative.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

A 9-month randomized controlled trial involving 1,147 schoolchildren showed that fitness programs significantly improved fitness levels and reduced diastolic blood pressure and obesity in girls, indicating potential long-term cardiovascular benefits.

Nutrition interventions were effective in reducing fat and sugar intake among children, particularly in girls, but fitness programs yielded better results overall, suggesting that tailored health programs for boys and girls are necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled evaluation of a fitness and nutrition intervention program on cardiovascular health in 10- to 12-year-old children. Vandongen, R., Jenner, DA., Thompson, C., et al.[2019]

The IMPROVE study is a cluster-randomized controlled trial involving 30 schools and approximately 1400 families, designed to evaluate the effectiveness of two different bundles of implementation strategies for the Healthy School Start program over 12 and 24 months.

The study aims to enhance intervention fidelity and monitor health outcomes related to childhood obesity and type 2 diabetes risk in parents, providing insights into effective implementation strategies tailored to specific school contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. Elinder, LS., Wiklund, CA., Norman, Å., et al.[2021]

Incorporating community engagement principles in school-based obesity prevention interventions significantly improves the achievement of weight-related outcomes, with studies achieving an average of 46% of their targeted outcomes.

There is a strong positive correlation (r = 0.66) between the level of community engagement and overall outcome performance, indicating that effective partnerships and capacity-building efforts enhance the effectiveness of these health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-engaged interventions on diet, activity, and weight outcomes in U.S. schools: a systematic review. Krishnaswami, J., Martinson, M., Wakimoto, P., et al.[2022]

The Heart Smart Family Health Promotion Program, involving 19 high-risk children and 23 parents over 12 weeks, successfully improved eating habits, physical activity, and cardiovascular knowledge, leading to significant health benefits.

Both children and parents experienced positive changes, including reduced blood pressure and stabilized weight gain in children, demonstrating the program's effectiveness as a cardiovascular risk intervention that can be adapted for clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular intervention for high-risk families: the Heart Smart Program. Johnson, CC., Nicklas, TA., Arbeit, ML., et al.[2019]

School-based physical activity interventions are effective in increasing fitness levels among schoolchildren, with strong evidence from 18 randomized controlled trials involving 6,207 participants, particularly from higher quality studies with a high dose of intervention.

While some interventions showed promise in reducing skin-fold thickness and increasing beneficial cholesterol levels, the effects on body mass index, body fat, and other cardiometabolic outcomes remain inconclusive, indicating a need for more high-quality studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of school-based interventions for direct delivery of physical activity on fitness and cardiometabolic markers in children and adolescents: a systematic review of randomized controlled trials. Sun, C., Pezic, A., Tikellis, G., et al.[2018]

The 'Be a Fit Kid' program, implemented over 10 weeks in a fourth-grade curriculum, led to significant improvements in fitness, body fat, nutrition knowledge, and dietary habits among students.

Compared to a control group, the intervention group showed notable enhancements in cardiovascular health markers, suggesting that school-based physical activity and nutrition programs can effectively reduce the risk of lifestyle-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Be a Fit Kid: nutrition and physical activity for the fourth grade. Slawta, JN., DeNeui, D.[2019]

The 'Know Your Body' (KYB) program effectively reduced several coronary heart disease risk factors among 1,041 black students over a longitudinal study that began in 1983, showing significant improvements in blood pressure and cholesterol levels during follow-ups.

Students with the best KYB teachers experienced notable reductions in total serum cholesterol after one year, indicating that the quality of program implementation plays a crucial role in its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factor prevention in black school children: the "Know Your Body" evaluation project. Bush, PJ., Zuckerman, AE., Taggart, VS., et al.[2022]

The Spartners for Heart Health program aims to prevent cardiovascular disease risk factors in 5th grade students by enhancing their knowledge and behaviors related to nutrition and physical activity through a structured curriculum and mentorship from college students.

This pilot study involves a multi-disciplinary approach with assessments conducted at the beginning and end of the school year, indicating a focus on measurable outcomes in improving children's heart health and promoting sustainable interventions in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(S)Partners for Heart Health: a school-based program for enhancing physical activity and nutrition to promote cardiovascular health in 5th grade students. Carlson, JJ., Eisenmann, JC., Pfeiffer, KA., et al.[2021]

The CATCH trial is evaluating the impact of a school-based cardiovascular health program enhanced by family involvement, with a focus on healthier eating and increased physical activity for students in Grades 3 to 5.

In the third-grade Family Fun Nights, the program achieved a 67% student participation rate, with an average family member to student ratio of 2:1, indicating strong engagement from families and teachers in promoting cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CATCH: family process evaluation in a multicenter trial. Johnson, CC., Osganian, SK., Budman, SB., et al.[2019]

The Heart Smart program effectively improved children's health knowledge and lunch choices, leading to significant reductions in cholesterol levels among those who selected healthier options.

The program's comprehensive approach, which included changes in school lunches, physical education, and cardiovascular screenings, resulted in improved exercise performance and increased levels of beneficial high-density lipoprotein cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Heart Smart cardiovascular school health promotion: behavior correlates of risk factor change. Arbeit, ML., Johnson, CC., Mott, DS., et al.[2019]

The NHLBI has supported over a decade of research focused on improving cardiovascular health behaviors among youth through school and family-based programs, highlighting the importance of addressing these behaviors early in life.

A synthesis of 10 funded studies reveals diverse approaches, including curriculum changes, parental involvement, and environmental modifications, effectively targeting various age groups and ethnic/racial backgrounds to promote healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis of cardiovascular behavioral research for youth health promotion. Stone, EJ., Perry, CL., Luepker, RV.[2019]

The CATCH study is a comprehensive intervention program targeting cardiovascular health behaviors in third to fifth graders across 96 schools in four states, focusing on improving eating habits, physical activity, and reducing cigarette smoking.

Phase II of the study emphasizes the importance of classroom curricula, school environmental changes, and family involvement to effectively promote cardiovascular health among youth, providing a structured framework for school-based health promotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based cardiovascular health promotion: the child and adolescent trial for cardiovascular health (CATCH). Perry, CL., Stone, EJ., Parcel, GS., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A controlled evaluation of a fitness and nutrition intervention program on cardiovascular health in 10- to 12-year-old children. [2019]

2. England pubmed.ncbi.nlm.nih.gov

IMplementation and evaluation of the school-based family support PRogram a Healthy School Start to promote child health and prevent OVErweight and obesity (IMPROVE) - study protocol for a cluster-randomized trial. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Community-engaged interventions on diet, activity, and weight outcomes in U.S. schools: a systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular intervention for high-risk families: the Heart Smart Program. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effects of school-based interventions for direct delivery of physical activity on fitness and cardiometabolic markers in children and adolescents: a systematic review of randomized controlled trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Be a Fit Kid: nutrition and physical activity for the fourth grade. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factor prevention in black school children: the "Know Your Body" evaluation project. [2022]

8. England pubmed.ncbi.nlm.nih.gov

(S)Partners for Heart Health: a school-based program for enhancing physical activity and nutrition to promote cardiovascular health in 5th grade students. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

CATCH: family process evaluation in a multicenter trial. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

The Heart Smart cardiovascular school health promotion: behavior correlates of risk factor change. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Synthesis of cardiovascular behavioral research for youth health promotion. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

School-based cardiovascular health promotion: the child and adolescent trial for cardiovascular health (CATCH). [2019]