Texas A&M AgriLife Dallas Center
Dallas, Texas, 75252, United States
Location status: Recruiting
Location contact
Alexander MacMillan Uribe, PhD
CONTACT
Jacob Szeszulski, PhD
CONTACT
NCT Number: NCT05867433
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.
Interested in participating?
Request Info8 year and older
All sexes
Interventional
Not applicable
Dallas, Texas, 75252, United States
Location status: Recruiting
Alexander MacMillan Uribe, PhD
CONTACT
Jacob Szeszulski, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
School Inclusion Criteria:
School Exclusion Criteria:
Student Inclusion Criteria:
Student Exclusion Criteria:
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.
No STHS program
The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.
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:
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:
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:
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.
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.
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.
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.
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.
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Height will be measured using a stadiometer in inches.
Time frame: Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Weight will be measured with a scale in pounds.
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.
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.
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.
Time frame: Baseline to 9 months
Sedentary time will be measured using Actigraph accelerometers.
Time frame: Baseline to 9 months
Sleep time will be measured using Actigraph accelerometers.
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.
Time frame: Baseline to 9 months
The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey.
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.
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).
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).
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).
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Alexandra L MacMillan Uribe, PhD
CONTACT
Jacob S Szeszulski, PhD
CONTACT
Texas A&M University
Other
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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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