Cardiovascular DiseasesNCT07079995
Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
A study testing Mentoring program and Waitlist in people with Cardiovascular Diseases and Physical Activity, run by Texas A&M University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Physical Activity, Nutrition
- What is being tested?
- Mentoring program and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
School Inclusion Criteria:
- located in Central and East Texas
- Public school
Student Inclusion Criteria
- enrolled in the 4th, 5th, 6th, 7th, 8th, or 9th grade
- able to read, speak, and write in English
Student Exclusion Criteria:
- any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas A&M AgriLife Dallas Center
Dallas, Texas, 75252
Allyson Schaefers, 9729529629, allyson.schaefers@ag.tamu.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, Physical Activity, Nutrition
- Being tested
- Mentoring program, Waitlist
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentoring programBehavioural
Schools in this group will participate in meetings and receive newsletters to help with program implementation.
WaitlistBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HSRC + Standard Implementation | No intervention | Participants in this group will receive HSRC in the first year of enrollment with standard implementation. [schools (n=5), participants (n=225)] |
| HSRC + Mentoring Program | Experimental | Participants in this group will receive HSRC in the first year of enrollment with the mentoring program. [schools (n=5), participants (n=225)] Receives: Behavioral: Mentoring program |
| Waitlist Control + HSRC + Standard Implementation | Experimental | Participants in this group will receive HSRC with standard implementation one year after enrollment. [schools (n=5), participants (n=225)] Receives: Behavioral: Waitlist |
| Waitlist Control + HSRC + Mentoring Program | Experimental | Participants in this group will receive HSRC with the mentoring program one year after enrollment. [schools (n=5), participants (n=225)] Receives: Behavioral: Mentoring program; Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: Baseline, 9 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline, 9 months
Number of students reached
Measured: Baseline, 9 months
Total program dosage delivered
Measured: Baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Jacob Szeszulski, Principal investigator, Institute for Advancing Health through Agriculture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079995
- Sponsor's protocol ID
- HSRC DRCT STUDY2025-0650
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Schaefers A, Beattie CM, de Mello GT, George A, Marstall K, Gardner J, Szeszulski J. Healthy school recognized campus: design and methodology of a hybrid type 2 implementation-effectiveness cluster randomized trial. Implement Sci. 2026 Feb 5;21(1):19. doi: 10.1186/s13012-026-01487-2.
PubMed 41645239
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
- ClinicalTrials.gov ID
- NCT07079995
- Acronym / sponsor ID
- HSRC DRCT STUDY2025-0650
- Conditions
- Cardiovascular Diseases, Physical Activity, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HSRC + Standard Implementation | No intervention | –Participants in this group will receive HSRC in the first year of enrollment with standard implementation. [schools (n=5), participants (n=225)] |
| HSRC + Mentoring Program | Experimental | Behavioral: Mentoring programParticipants in this group will receive HSRC in the first year of enrollment with the mentoring program. [schools (n=5), participants (n=225)] |
| Waitlist Control + HSRC + Standard Implementation | Experimental | Behavioral: WaitlistParticipants in this group will receive HSRC with standard implementation one year after enrollment. [schools (n=5), participants (n=225)] |
| Waitlist Control + HSRC + Mentoring Program | Experimental | Behavioral: Mentoring program, Behavioral: WaitlistParticipants in this group will receive HSRC with the mentoring program one year after enrollment. [schools (n=5), participants (n=225)] |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentoring programSchools in this group will participate in meetings and receive newsletters to help with program implementation. | Behavioural | HSRC + Mentoring Program, Waitlist Control + HSRC + Mentoring Program |
| WaitlistSchools 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. | Behavioural | Waitlist Control + HSRC + Mentoring Program, Waitlist Control + HSRC + Standard Implementation |
Primary outcome
Body mass index (BMI)
Time frame: Baseline, 9 months
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.
Acceptability of the HSRC program
Time frame: Baseline, 9 months
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.)
Appropriateness of the HSRC program
Time frame: Baseline, 9 months
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.)
Feasibility of the HSRC program
Time frame: Baseline, 9 months
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.)
4 secondary outcomes
Concentration of subdermal carotenoids
Time frame: Baseline, 9 months
Accelerometer-derived physical activity estimation
Time frame: Baseline, 9 months
Number of students reached
Time frame: Baseline, 9 months
Total program dosage delivered
Time frame: Baseline, 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 41645239Schaefers A, Beattie CM, de Mello GT, George A, Marstall K, Gardner J, Szeszulski J. Healthy school recognized campus: design and methodology of a hybrid type 2 implementation-effectiveness cluster randomized trial. Implement Sci. 2026 Feb 5;21(1):19. doi: 10.1186/s13012-026-01487-2.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob Szeszulski principal investigator
Institute for Advancing Health through Agriculture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentoring program and Waitlist in people with Cardiovascular Diseases and Physical Activity, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Szeszulski (972-952-9202, jacob.szeszulski@agnet.tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) (time frame: Baseline, 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.