← Back to Search

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

Be younger than 18 years old

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor

140 Previous Clinical Trials

23,606 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,215,859 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants under the age of fifty being admitted into this experiment?

"This medical trial is open to people aged between 10 and 15 years old."

Answered by AI

Is this research currently open to new participants?

"Clinicaltrials.gov affirms that this medical study is currently recruiting patients, having first been posted on September 1st 2023 and last updated a month later."

Answered by AI

What is the upper limit of enrollees for this clinical trial?

"Affirmative, the information listed on clinicaltrials.gov points to this trial actively recruiting participants. This experiment was initially announced on September 1st 2023 and has since been updated on September 26th 2023. The study requires 500 volunteers at a single medical facility."

Answered by AI

Could I be considered a candidate for this experiment?

"A total of 500 individuals, aged 10-15 and presently affected by cardiovascular disease, are being admitted to this medical trial. Participants must also meet the following requirements: > 50 6th/7th grade students, ≥ 40% economically disadvantaged students, ≥ 40% Black & Hispanic students from a single school."

Answered by AI

What aims is this investigation endeavoring to attain?

"This trial's primary outcome is to measure the Positive Youth Development score across four time points: Baseline, 9 months (immediate post intervention), 4 months and 12 months. Researchers will also consider secondary metrics such as HDL cholesterol concentration that will be measured using a Cholestech LDX analyzer from capillary blood samples collected after an overnight fast, weight in pounds tracked by a scale, and body mass index calculated with data from height measurements taken by stadiometer."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

2024. "Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867433.