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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867433
• Other study ID #: IRB2022-1159D
• Secondary ID: R01MD018214
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: April 15, 2027

Study information

• Verified date: April 2024
• Source: Texas A&M University
• Contact: Jacob S Szeszulski, PhD
• Phone: 972-231-5362
• Email: jacob.szeszulski[@]ag.tamu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Nutrition
• Physical Activity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas A&M AgriLife Dallas Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of metabolic syndrome (MetS)	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	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Primary	Change in the number of MetS risk factors	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	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Primary	Positive Youth Development score	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)	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Blood pressure level	Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Concentration of blood glucose	Glucose will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Waist circumference	Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Concentration of HDL cholesterol	HDL-C will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Concentration of serum triglycerides	Triglycerides will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Height	Height will be measured using a stadiometer in inches.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Weight	Weight will be measured with a scale in pounds.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Body mass index (BMI)	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.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Concentration of subdermal carotenoids	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.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	Accelerometer-derived physical activity estimation	Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.	Baseline to 9 months
Secondary	Sedentary time	Sedentary time will be measured using Actigraph accelerometers.	Baseline to 9 months
Secondary	Time spent sleeping	Sleep time will be measured using Actigraph accelerometers.	Baseline to 9 months
Secondary	Physical fitness capacity estimation	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.	Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
Secondary	School physical activity and nutrition environment assessment	The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey.	Baseline to 9 months
Secondary	Assessment of perceptions of school environments and school-specific dietary intake patterns	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.	Baseline to 9 months
Secondary	Assessment of perceived sociopolitical control	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).	Baseline to 9 months
Secondary	Assessment of assertiveness	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).	Baseline to 9 months
Secondary	Assessment of participatory competence and decision-making	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).	Baseline to 9 months
Secondary	Assessment of advocacy outcome efficacy	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).	Baseline to 9 months
Secondary	Peer concentration of subdermal carotenoids	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.	Baseline to 9 months
Secondary	Peer Body mass index (BMI)	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.	Baseline to 9 months
Secondary	Peer physical fitness capacity estimation	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.	Baseline to 9 months