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NCT Number: NCT05867433

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

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.

Title 1 middle schools in Texas (n=20) with > 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (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) (n=20-25 students per school).

The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STHS Intervention

Behavioral

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

Behavioral

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 outcomes

  1. Presence or absence of metabolic syndrome (MetS)

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels.

    MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors)

    Measures to determine MetS risk factors:

    • Abdominal obesity: waist circumference >90th percentile for child's sex and age
    • High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
    • High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
    • Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
    • High triglyceride level: Triglyceride level ≥ 1.7mmol/L
  2. Change in the number of MetS risk factors

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors)

    Measures to determine MetS risk factors:

    • Abdominal obesity: waist circumference >90th percentile for child's sex and age
    • High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
    • High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
    • Low HDL cholesterol: HDL cholesterol <1.03 mmol/L
    • High triglyceride level: Triglyceride level ≥ 1.7mmol/L
  3. Positive Youth Development score

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth.

    The five dimensions measured are:

    • Competence (sense of proficiency)
    • Confidence (self-worth, self-efficacy)
    • Character (adherence to societal and cultural rules)
    • Connection (bonds with people and institutions)
    • Caring (sympathy and empathy towards others)

Secondary outcomes

  1. Blood pressure level

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.

  2. Concentration of blood glucose

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Glucose will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.

  3. Waist circumference

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.

  4. Concentration of HDL cholesterol

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    HDL-C will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.

  5. Concentration of serum triglycerides

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Triglycerides will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.

  6. Height

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Height will be measured using a stadiometer in inches.

  7. Weight

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Weight will be measured with a scale in pounds.

  8. Body mass index (BMI)

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Weight will be measured with a scale, and height will be measured using a stadiometer. BMI will be calculated as BMI = (weight (lb)/height (inches)2) x 703.

  9. Concentration of subdermal carotenoids

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    The concentration of subdermal carotenoids will assess the changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.

  10. Accelerometer-derived physical activity estimation

    Time frame: Baseline to 9 months

    Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.

  11. Sedentary time

    Time frame: Baseline to 9 months

    Sedentary time will be measured using Actigraph accelerometers.

  12. Time spent sleeping

    Time frame: Baseline to 9 months

    Sleep time will be measured using Actigraph accelerometers.

  13. Physical fitness capacity estimation

    Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

    Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.

  14. School physical activity and nutrition environment assessment

    Time frame: Baseline to 9 months

    The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey.

  15. Assessment of perceptions of school environments and school-specific dietary intake patterns

    Time frame: Baseline to 9 months

    Perceptions related to physical activity and nutrition within the school setting will be measured using the Perceptions of the Environment and Patterns of Diet at School (PEA-PODS) survey.

  16. Assessment of perceived sociopolitical control

    Time frame: Baseline to 9 months

    Perceived sociopolitical control will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' perceived sociopolitical control (i.e., participation in advocacy programs and optimism for change).

  17. Assessment of assertiveness

    Time frame: Baseline to 9 months

    Assertiveness will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' assertiveness (i.e., ability to engage with adults and peers).

  18. Assessment of participatory competence and decision-making

    Time frame: Baseline to 9 months

    Participatory competence and decision-making will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' participatory competence and decision-making (i.e., ability to influence group decision-making).

  19. Assessment of advocacy outcome efficacy

    Time frame: Baseline to 9 months

    Advocacy outcome efficacy will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' advocacy outcome efficacy (i.e., belief in their ability to work with others to improve the school's physical activity and nutrition environment).

  20. Peer concentration of subdermal carotenoids

    Time frame: Baseline to 9 months

    The concentration of subdermal carotenoids will assess peers' engagement in health behaviors changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy.

  21. Peer Body mass index (BMI)

    Time frame: Baseline to 9 months

    Peers' engagement in health behaviors will be measured by the change in peers' BMI. Weight will be measured with a scale, and height will be measured using a stadiometer. Calculate BMI with the formula: BMI = (weight (lb)/height (inches)2) x 703.

  22. Peer physical fitness capacity estimation

    Time frame: Baseline to 9 months

    Peers' engagement in health behaviors will be measured by the change in peers' physical fitness. Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra L MacMillan Uribe, PhD

CONTACT

[email protected]

972-952-9275

Jacob S Szeszulski, PhD

CONTACT

[email protected]

972-231-5362

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 22, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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