An interventional study of Mentoring program and Waitlist in Cardiovascular Diseases, Physical Activity and Nutrition, sponsored by Texas A&M University. Recruiting at 1 site in United States. Open to participants aged 8 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Texas A&M University · Not applicable, Interventional, and Prevention
Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to conduct a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT) to assess both Healthy School Recognized Campus (HSRC) and the mentoring program.
This study uses a type 2 hybrid implementation-effectiveness, cluster dual randomized controlled trial (DRCT). DRCTs include two randomized controlled trials within the same study: one testing an intervention (i.e., HSRC) and one testing an implementation strategy (i.e., the mentoring program).
Schools in Central and East Texas (n=20) of similar socio-economic status will be randomized at baseline to either the HSRC condition or the Waitlist Control condition. In the HSRC condition, schools will attempt to deliver youth and adult physical activity or nutrition programs. In the Waitlist Control condition, schools will not add or remove any current physical activity and/or healthy eating programs, and will receive HSRC the next school year. Schools will also be randomized to receive the mentoring program or standard implementation immediately or after being a waitlist control.
Aim 1: Determine the effectiveness of the HSRC initiative compared to a control group on BMI-Z score, physical activity, and skin carotenoids (i.e., fruit and vegetable intake).
For Aim 1, the investigators will compare outcomes in 10 Texas schools that receive HSRC with 10 Waitlist Control communities.
Aim 2: Determine the impact of the mentoring program compared to standard implementation on short-term (acceptability, appropriateness, feasibility) and long-term (number of students reached, total dosage delivered) implementation outcomes.
For Aim 2, the investigators will compare outcomes in 10 Texas schools that receive the mentoring program with 10 that receive standard implementation.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 900 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
School Inclusion Criteria:
Student Inclusion Criteria
Student Exclusion Criteria:
Participants in this group will receive HSRC in the first year of enrollment with standard implementation. \[schools (n=5), participants (n=225)\]
Participants in this group will receive HSRC in the first year of enrollment with the mentoring program. \[schools (n=5), participants (n=225)\]
Behavioral: Mentoring program
Participants in this group will receive HSRC with standard implementation one year after enrollment. \[schools (n=5), participants (n=225)\]
Behavioral: Waitlist
Participants in this group will receive HSRC with the mentoring program one year after enrollment. \[schools (n=5), participants (n=225)\]
Behavioral: Mentoring program · Behavioral: Waitlist
Schools in this group will participate in meetings and receive newsletters to help with program implementation.
Schools in this group will wait 1 year to receive HSRC. Schools will not add or remove any current physical activity and/or healthy eating programs.
Body mass index (BMI)
Weight will be measured with a scale (in pounds), and height will be measured using a stadiometer (in inches). Weight and height will be combined to report BMI as follows, BMI = (weight (lb)/height (inches)2) x 703.
Time frame: Baseline, 9 months
Acceptability of the HSRC program
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM) 4-item survey. The survey will be used to assess program implementers' perceived acceptability of the program (i.e., This program seems fine.)
Time frame: Baseline, 9 months
Appropriateness of the HSRC program
Appropriateness will be assessed with the Intervention Appropriateness Measure (IAM) 4-item survey. The survey will assess program implementers' perception of the appropriateness of the program (e.g., This program seems suitable.)
Time frame: Baseline, 9 months
Feasibility of the HSRC program
Feasibility will be assessed using the Feasibility of Intervention Measure (FIM) 4-item survey. The survey will assess program implementers' perception of the program's feasibility (e.g., This program seems doable.)
Time frame: Baseline, 9 months
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.
Time frame: Baseline, 9 months
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.
Time frame: Baseline, 9 months
Number of students reached
Time frame: Baseline, 9 months
Total program dosage delivered
Time frame: Baseline, 9 months
Blood pressure
Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.
Time frame: Baseline, 9 months
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.
Time frame: Baseline, 9 months
Waist circumference
Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.
Time frame: Baseline, 9 months
Plan to share: Yes — Data will include student biometrics, student surveys, and implementer surveys. Student biometrics will include assessments of height, weight, physical activity, fruit and vegetable consumption, cardiovascular fitness, and markers of cardiometabolic health (e.g., blood pressure). Student surveys will include assessment of student demographics, physical activity, healthy eating, and other important outcomes (e.g., positive youth development). Implementer surveys will include demographics and assessment of implementation outcomes as they relate to programs that are a part of healthy school recognized campus.
Time frame: start: 3/31/2028
Access criteria: Researchers can access through ClinicalTrials.gov or Open Science Framework (general)
Started Sep 2025 (actual). Primary completion is estimated for Jun 2028, 33 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 33 months is above that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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