Recruiting

Observational Study

Sponsor:

Texas A&M University

Code:

NCT05867433

Conditions

Cardiovascular Diseases

Nutrition

Physical Activity

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

STHS Intervention

Usual Care

Study Details

Brief summary:

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.

Conditions

Cardiovascular Diseases

Nutrition

Physical Activity

Study ID

NCT05867433

Start date

Sep 27, 2023

Status verified date

Sep, 2025

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

School Inclusion Criteria:

  • > 50 6th and 7th grade students
  • > 40% economically disadvantaged students
  • > 40% Black and Hispanic students

School Exclusion Criteria:

Student Inclusion Criteria:

  • 6th or 7th grade student
  • Attend a Title 1 middle school that is participating in the STHS intervention
  • Read and understand English

Student Exclusion Criteria:

  • Participation in a weight loss program in the past 3 months
  • Presence of a condition that prevents participation in physical activity

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: STHS Intervention

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

other: Usual Care

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.

Interventions

STHS Intervention

STHS program

The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors.

Usual Care

No STHS program

The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.

Primary outcome measure

  • Presence or absence of metabolic syndrome (MetS) [ Time Frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention ]
  • Change in the number of MetS risk factors [ Time Frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention ]
  • Positive Youth Development score [ Time Frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention ]

Central Contacts and Locations

Central contacts

Jacob S Szeszulski, PhD

972-231-5362jacob.szeszulski@ag.tamu.edu

Alexandra L MacMillan Uribe, PhD

972-952-9275lexi.macmillanuribe@ag.tamu.edu

Locations

Texas A&M AgriLife Dallas Center

Recruiting

Dallas, Texas, United States, 75252

Contacts

Jacob Szeszulski, PhD

972-231-5362jacob.szeszulski@ag.tamu.edu

Alexander MacMillan Uribe, PhD

972-952-9275lexi.macmillanuribe@ag.tamu.edu

More Information

Sponsor

Texas A&M University

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas A&M University on 2025-09-12.