STHS Program for Cardiovascular Health in Youth

Overseen By Alexandra L MacMillan Uribe, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: Weight loss program, Physical activity condition

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the STHS Intervention treatment for cardiovascular health in youth?

Research shows that school-based programs like the CATCH Eat Smart Program and the Heart Smart Program, which focus on improving diet and physical activity, can effectively reduce risk factors for heart disease in children. These programs have led to healthier eating habits, increased physical activity, and improved blood pressure levels, suggesting that similar interventions could benefit cardiovascular health in youth. ^{1 2 3 4 5}

Is the STHS Program for Cardiovascular Health in Youth safe for humans?

The research on school-based programs for cardiovascular health in children, like the STHS Program, generally focuses on improving heart health through physical activity and nutrition. These programs have been evaluated for their impact on risk factors like cholesterol and blood pressure, and no significant safety concerns have been reported in the studies. ^{3 5 6 7 8}

How is the STHS Program for Cardiovascular Health in Youth treatment different from other treatments for cardiovascular health in children?

The STHS Program is unique because it is a school-based intervention that combines fitness, nutrition, and behavioral support to improve cardiovascular health in children, focusing on changing eating habits and physical activity rather than using medication. ^{1 2 4 5 6}

What is the purpose of this trial?

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

Eligibility Criteria

This trial is for middle school students, specifically those in the 6th and 7th grades. It aims to include a diverse group with at least 40% Black and Hispanic students and another 40% from economically disadvantaged backgrounds. Students who have been in a weight loss program recently or cannot participate in physical activity due to health conditions are not eligible.

Inclusion Criteria

School: > 50 6th and 7th grade students

School: 40% economically disadvantaged students

School: 40% Black and Hispanic students

Exclusion Criteria

Student: Participation in a weight loss program in the past 3 months

I have a condition that stops me from doing physical activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the Strong Teens for Healthy Schools (STHS) program to improve physical activity and healthy eating behaviors

9 months

Regular school-based sessions

Immediate Post-Intervention Assessment

Assessment of primary and secondary outcomes immediately after the intervention

1 month

Follow-up

Participants are monitored for long-term outcomes and changes in cardiovascular disease-related health

12 months

Treatment Details

Interventions

• STHS Intervention
• Usual Care

Trial Overview The Strong Teens for Healthy Schools (STHS) program is being tested against usual care practices. STHS focuses on empowering students through civic engagement to enhance their physical activity, improve nutrition, and reduce cardiovascular disease risks by making positive changes within their school environments.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Participants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming.

Group II: STHS Intervention Experimental Treatment 1 Intervention

Participants in this group (10 schools) will participate in the STHS program.

STHS Intervention is already approved in United States for the following indications:

Approved in United States as STHS Intervention for:

• Improving physical activity and healthy eating behaviors
• Cardiovascular disease prevention

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The CATCH Eat Smart Program effectively reduced the percentage of calories from total fat by 4.1% and saturated fat by 1.3% in school lunches over a 2.5-year period in 56 intervention schools, compared to control schools.

While sodium content increased in both intervention and control schools, the increase was significantly lower in intervention schools, indicating a positive impact on the nutritional quality of school meals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the nutrient content of school lunches: results from the CATCH Eat Smart Food service Intervention. Osganian, SK., Ebzery, MK., Montgomery, DH., et al.[2015]

The Child and Adolescent Trial for Cardiovascular Health involved over 6000 students across 96 schools and demonstrated significant improvements in psychosocial factors related to cardiovascular health, such as dietary knowledge and self-efficacy for physical activity.

Schools that implemented a school-plus-family intervention showed greater positive changes in students' usual dietary behaviors and intentions to choose heart-healthy foods, highlighting the effectiveness of involving families in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. Edmundson, E., Parcel, GS., Perry, CL., et al.[2018]

The 'Action Schools! BC' program significantly improved cardiovascular fitness by 20% and reduced blood pressure increase by 5.7% in elementary-school children compared to usual practice, based on a study involving 268 children over one school year.

Despite these improvements in fitness and blood pressure, the program did not significantly change body mass index or blood lipid levels, indicating that while the intervention was effective in some areas, it may need further adjustments to address all cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action Schools! BC: a school-based physical activity intervention designed to decrease cardiovascular disease risk factors in children. Reed, KE., Warburton, DE., Macdonald, HM., 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]

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 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]

A study involving 195 high school students who previously participated in a cardiovascular risk reduction program in sixth grade showed that while obesity and high cholesterol levels remained stable, significant changes occurred in heart rate recovery and blood pressure over the years.

The only notable gender difference observed was in elevated cholesterol levels, which were more prevalent among female students, highlighting the need for targeted interventions in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk stability: from grade school to high school. Cowell, JM., Montgomery, AC., Talashek, M.[2019]

The 'Healthy Start' intervention, which modified food services in nine Head Start centers, led to a significant decrease in total serum cholesterol among preschool children, with a reduction of -6.0 mg/dL compared to only -0.4 mg/dL in control groups.

Children with initially elevated cholesterol levels who participated in the food service modification were 30% less likely to remain at risk for elevated cholesterol, demonstrating the intervention's effectiveness in promoting heart health without negatively impacting short-term growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk reduction in preschool children: the "Healthy Start" project. Williams, CL., Strobino, BA., Bollella, M., et al.[2019]

References

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

Changes in the nutrient content of school lunches: results from the CATCH Eat Smart Food service Intervention. [2015]

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

The effects of the child and adolescent trial for cardiovascular health intervention on psychosocial determinants of cardiovascular disease risk behavior among third-grade students. [2018]

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

Action Schools! BC: a school-based physical activity intervention designed to decrease cardiovascular disease risk factors in children. [2022]

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

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

5. 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]

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

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

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

Cardiovascular risk stability: from grade school to high school. [2019]

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

Cardiovascular risk reduction in preschool children: the "Healthy Start" project. [2019]