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

Sponsor
Texas A&M University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05867433
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
500
2
45

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: STHS Intervention
  • Behavioral: Usual Care
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
School-based cluster randomized controlled trialSchool-based cluster randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
May 1, 2027
Anticipated Study Completion Date :
May 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: STHS Intervention

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

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Presence or absence of metabolic syndrome (MetS) [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 [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 [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 Outcome Measures

  1. Blood pressure level [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 [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 [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 [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 [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 [Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention]

    Height will be measured using a stadiometer in inches.

  7. Weight [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) [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 [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 [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 [Baseline to 9 months]

    Sedentary time will be measured using Actigraph accelerometers.

  12. Time spent sleeping [Baseline to 9 months]

    Sleep time will be measured using Actigraph accelerometers.

  13. Physical fitness capacity estimation [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 [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 [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 [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 [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 [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 [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 [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas A&M University
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Texas A&M University
ClinicalTrials.gov Identifier:
NCT05867433
Other Study ID Numbers:
  • IRB2022-1159D
  • R01MD018214
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023