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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on a program designed to help middle school students improve heart health through better physical activity and eating habits. Conducted in schools, it aims to create positive changes in students' health environments. The trial compares two groups: one participating in the STHS Intervention program and another continuing with their usual activities. It suits 6th or 7th graders attending a Title 1 school involved in the program, who are not currently in a weight loss program and can engage in physical activities. As an unphased trial, this study provides students with a unique opportunity to contribute to research that could enhance school health programs.

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 prior data suggests that the STHS Intervention is safe for youth?

Research shows that the Strong Teens for Healthy Schools (STHS) program is a carefully designed plan to help middle school students make healthier lifestyle choices. The program encourages better physical activity and eating habits, which can improve heart health.

The STHS program is not a medication or medical treatment; it is primarily an educational and interactive activity. No reports of physical side effects or negative events have been linked to the program. Participants engage in community activities and learn about nutrition and exercise, which are generally safe and beneficial.

Previous studies have not shown any safety concerns with the STHS program. Since it focuses on education and encouraging positive behavior changes, participants are expected to receive it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STHS Intervention because it offers a fresh approach to improving cardiovascular health in youth. Unlike standard care, which often focuses on individual interventions like diet or exercise alone, the STHS program integrates physical activity, healthy eating, and positive youth development into a comprehensive school-based program. This holistic approach aims to create a supportive environment for students to develop lifelong healthy habits, potentially leading to more sustainable health outcomes compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for cardiovascular health in youth?

Research shows that the Strong Teens for Healthy Schools (STHS) program aims to improve heart health in middle school students by promoting better eating and exercise habits. In this trial, participants in the STHS Intervention arm will engage in group activities and lessons designed to lower the risk of metabolic syndrome, a group of conditions that can lead to heart disease and other health issues. The program involves students in making positive changes at their schools while teaching them about healthy eating and exercise. Early results suggest that students in the STHS Intervention arm may experience better health and a reduced risk of heart disease. The program also supports positive youth development, fostering lasting healthy habits. Meanwhile, participants in the Usual Care arm will continue with their current activities without additional interventions. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487017/

Strong Teens for Healthy Schools: Protocol for evaluating a ... The STHS program provides group-based physical activity and nutrition education to promote healthy behaviors and reduce MetS risk. The purpose of this ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05867433

Strong Teens for Healthy Schools Change Club: A Civic ... STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular ...

3. texas4h-hsrc.com texas4h-hsrc.com/sths/

Strong Teens Healthy Schools Strong Teens Healthy Schools is a civic engagement, positive youth development, and cardiovascular disease prevention program.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1616483/full

Educators' perceived barriers and facilitators to ... Introduction: Strong Teens for Healthy Schools (STHS) is a middle school program that focuses on improving healthy eating habits, physical ...

5. ctv.veeva.com ctv.veeva.com/study/strong-teens-for-healthy-schools-change-club-a-civic-engagement-approach-to-improving-physical-acti

Strong Teens for Healthy Schools Change Club: A Civic ... The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, ...

6. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1654678/full

Strong Teens for Healthy Schools: Protocol for evaluating a ... We will test the efficacy of STHS for reducing MetS risk and improving positive youth development outcomes among students at middle schools where >40% of ...