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

BEHAVIORAL

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.

BEHAVIORAL

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.

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: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L

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: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L

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: 1. Competence (sense of proficiency) 2. Confidence (self-worth, self-efficacy) 3. Character (adherence to societal and cultural rules) 4. Connection (bonds with people and institutions) 5. Caring (sympathy and empathy towards others)

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.