- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867433
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacob S Szeszulski, PhD
- Phone Number: 972-231-5362
- Email: jacob.szeszulski@ag.tamu.edu
Study Contact Backup
- Name: Alexandra L MacMillan Uribe, PhD
- Phone Number: 972-952-9275
- Email: lexi.macmillanuribe@ag.tamu.edu
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75252
- Recruiting
- Texas A&M AgriLife Dallas Center
-
Contact:
- Jacob Szeszulski, PhD
- Phone Number: 972-231-5362
- Email: jacob.szeszulski@ag.tamu.edu
-
Contact:
- Alexander MacMillan Uribe, PhD
- Phone Number: 972-952-9275
- Email: lexi.macmillanuribe@ag.tamu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STHS Intervention
Participants in this group (10 schools) will participate in the STHS program.
|
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.
|
No STHS program The usual care group will be offered the same activities as the intervention group after the conclusion of the research study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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:
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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:
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline to 9 months
|
Sedentary time
Time Frame: Baseline to 9 months
|
Sedentary time will be measured using Actigraph accelerometers.
|
Baseline to 9 months
|
Time spent sleeping
Time Frame: Baseline to 9 months
|
Sleep time will be measured using Actigraph accelerometers.
|
Baseline to 9 months
|
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.
|
Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention
|
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.
|
Baseline to 9 months
|
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.
|
Baseline to 9 months
|
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).
|
Baseline to 9 months
|
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).
|
Baseline to 9 months
|
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).
|
Baseline to 9 months
|
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).
|
Baseline to 9 months
|
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.
|
Baseline to 9 months
|
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.
|
Baseline to 9 months
|
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.
|
Baseline to 9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2022-1159D
- R01MD018214 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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