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Behavioral Intervention

STHS Program for Cardiovascular Health in Youth

N/A
Recruiting
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Awards & highlights

Study Summary

This trial program helps middle schoolers increase physical activity, healthy eating, and reduce risk of heart disease, while also creating positive change in their school health.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication, side effects may include muscle soreness from increased physical activity or adjustment issues as dietary habits change. However, these are typically mild and temporary as part of adopting healthier behaviors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the number of MetS risk factors
Positive Youth Development score
Presence or absence of metabolic syndrome (MetS)
Secondary outcome measures
Accelerometer-derived physical activity estimation
Assessment of advocacy outcome efficacy
Assessment of assertiveness
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 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 InterventionExperimental Treatment1 Intervention
Participants in this group (10 schools) will participate in the STHS program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
140 Previous Clinical Trials
23,857 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
393 Previous Clinical Trials
1,221,455 Total Patients Enrolled
~333 spots leftby Apr 2027
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