Cardiovascular DiseasesHSRCNCT05977959
Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
A study testing Mentoring Program, Enhanced Resources and Enhanced Engagement 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 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Physical Activity, Nutrition
- What is being tested?
- Mentoring Program, Enhanced Resources and Enhanced Engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
United States1 site
Texas A&M AgriLife Dallas Center
Dallas, Texas, 75252
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 improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.
Read the detailed description
The investigators will conduct a group randomized factorial trial using the Multiphase Optimization STrategy (MOST) framework to evaluate the impact (i.e., implementation and effectiveness) of three implementation strategies on program implementation and youth's cardiovascular disease risk. HSRC is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs.
Elementary schools in North and East Texas (n=16) of similar socio-economic status will be randomized at baseline to receive either 3, 2, 1, or no strategies to support HSRC program implementation. All schools will participate in HSRC during the full school year.
The investigators hypothesize that one strategy will result in significantly greater HSRC implementation and effectiveness than the other strategies tested.
- Conditions
- Cardiovascular Diseases, Physical Activity, Nutrition
- Being tested
- Mentoring Program, Enhanced Resources, Enhanced Engagement
- 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 discussion boards and receive newsletters to help with program implementation.
Enhanced ResourcesBehavioural
Schools in this group will receive extra resources such as program incentives to aid in program implementation.
Enhanced EngagementBehavioural
Schools in this group will participate in program contests to aid program implementation.
| Study group | Role | What they receive |
|---|---|---|
| Mentoring Program | Experimental | Participants in this group will receive the Mentoring Program strategy in addition to Healthy School Recognized Campus. Receives: Behavioral: Mentoring Program |
| Enhanced Resources | Experimental | Participants in this group will receive the Enhanced Resources strategy in addition to Healthy School Recognized Campus. Receives: Behavioral: Enhanced Resources |
| Enhanced Engagement | Experimental | Participants in this group will receive the Enhanced Engagement strategy in addition to Healthy School Recognized Campus. Receives: Behavioral: Enhanced Engagement |
| No Intervention | No intervention | All schools will participate in the HSRC initiative. The requirements for the initiative are to complete a school-wide walking program, 1 youth, and 1 adult program from a list of available programs that make up the initiative. |
| Mentoring + Enhanced Resources | Experimental | Participants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus. Receives: Behavioral: Mentoring Program; Behavioral: Enhanced Resources |
| Mentoring + Enhanced Engagement | Experimental | Participants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. Receives: Behavioral: Mentoring Program; Behavioral: Enhanced Engagement |
| Enhanced Resources + Enhanced Engagement | Experimental | Participants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. Receives: Behavioral: Enhanced Resources; Behavioral: Enhanced Engagement |
| Mentoring + Enhanced Resources + Enhanced Engagement | Experimental | Participants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. Receives: Behavioral: Mentoring Program; Behavioral: Enhanced Resources; Behavioral: Enhanced Engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 9 months (immediate post intervention)
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
Measured: Baseline, 9 months (immediate post intervention)
Number of programs schools delivered (in addition to Walk Across Texas)
Measured: Baseline, 9 months (immediate post intervention)
Number of sessions delivered for each program
Measured: Baseline, 9 months (immediate post intervention)
Length of the sessions delivered
Measured: Baseline, 9 months (immediate post intervention)
Individual-level attendance data for programs delivered
Measured: Baseline, 9 months (immediate post intervention)
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 (immediate post intervention)
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 (immediate post intervention)
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.
Measured: Baseline, 9 months (immediate post intervention)
Secondary outcomes (7)
Blood pressure level
Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.
Measured: Baseline, 9 months (immediate post intervention)
Concentration of blood glucose
Glucose will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention)
Waist circumference
Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.
Measured: Baseline, 9 months (immediate post intervention)
Concentration of HDL cholesterol
HDL-C will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention)
Concentration of serum triglycerides
Triglycerides will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.
Measured: Baseline, 9 months (immediate post intervention)
Height
Height will be measured using a stadiometer in inches.
Measured: Baseline, 9 months (immediate post intervention)
Weight
Weight will be measured with a scale in pounds.
Measured: Baseline, 9 months (immediate post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start13 Sep 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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
- 159 participants (actual)
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, PhD, Principal investigator, Texas A&M AgriLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977959
- Sponsor's protocol ID
- AHA HSRC
- Acronym
- HSRC
- Status last verified
- Jun 2025
- First submitted
- 24 Jul 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Szeszulski J, Schaefers A, De Mello GT, Gardner J, George A, MacMillan Uribe A, Rethorst CD, Seguin-Fowler RA, Xin L. Design and methodology of a cluster randomized factorial trial to optimize implementation strategies for the Healthy School Recognized Campus initiative. Front Public Health. 2025 Oct 30;13:1652485. doi: 10.3389/fpubh.2025.1652485. eCollection 2025.
PubMed 41246086
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
- ClinicalTrials.gov ID
- NCT05977959
- Acronym / sponsor ID
- HSRC / AHA HSRC
- Conditions
- Cardiovascular Diseases, Physical Activity, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Aug 2023 (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 improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.
Detailed description
The investigators will conduct a group randomized factorial trial using the Multiphase Optimization STrategy (MOST) framework to evaluate the impact (i.e., implementation and effectiveness) of three implementation strategies on program implementation and youth's cardiovascular disease risk. HSRC is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs.
Elementary schools in North and East Texas (n=16) of similar socio-economic status will be randomized at baseline to receive either 3, 2, 1, or no strategies to support HSRC program implementation. All schools will participate in HSRC during the full school year.
The investigators hypothesize that one strategy will result in significantly greater HSRC implementation and effectiveness than the other strategies tested.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Mentoring Program | Experimental | Behavioral: Mentoring ProgramParticipants in this group will receive the Mentoring Program strategy in addition to Healthy School Recognized Campus. |
| Enhanced Resources | Experimental | Behavioral: Enhanced ResourcesParticipants in this group will receive the Enhanced Resources strategy in addition to Healthy School Recognized Campus. |
| Enhanced Engagement | Experimental | Behavioral: Enhanced EngagementParticipants in this group will receive the Enhanced Engagement strategy in addition to Healthy School Recognized Campus. |
| No Intervention | No intervention | –All schools will participate in the HSRC initiative. The requirements for the initiative are to complete a school-wide walking program, 1 youth, and 1 adult program from a list of available programs that make up the initiative. |
| Mentoring + Enhanced Resources | Experimental | Behavioral: Mentoring Program, Behavioral: Enhanced ResourcesParticipants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus. |
| Mentoring + Enhanced Engagement | Experimental | Behavioral: Mentoring Program, Behavioral: Enhanced EngagementParticipants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. |
| Enhanced Resources + Enhanced Engagement | Experimental | Behavioral: Enhanced Resources, Behavioral: Enhanced EngagementParticipants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. |
| Mentoring + Enhanced Resources + Enhanced Engagement | Experimental | Behavioral: Mentoring Program, Behavioral: Enhanced Resources, Behavioral: Enhanced EngagementParticipants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment
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 discussion boards and receive newsletters to help with program implementation. | Behavioural | Mentoring + Enhanced Engagement, Mentoring + Enhanced Resources, Mentoring + Enhanced Resources + Enhanced Engagement, Mentoring Program |
| Enhanced ResourcesSchools in this group will receive extra resources such as program incentives to aid in program implementation. | Behavioural | Enhanced Resources, Enhanced Resources + Enhanced Engagement, Mentoring + Enhanced Resources, Mentoring + Enhanced Resources + Enhanced Engagement |
| Enhanced EngagementSchools in this group will participate in program contests to aid program implementation. | Behavioural | Enhanced Engagement, Enhanced Resources + Enhanced Engagement, Mentoring + Enhanced Engagement, Mentoring + Enhanced Resources + Enhanced Engagement |
Primary outcome
Presence or absence of metabolic syndrome (MetS)
Time frame: Baseline, 9 months (immediate 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: 1. Abdominal obesity: waist circumference >90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Change in the number of MetS risk factors
Time frame: Baseline, 9 months (immediate 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: 1. Abdominal obesity: waist circumference >90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol <1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Number of programs schools delivered (in addition to Walk Across Texas)
Time frame: Baseline, 9 months (immediate post intervention)
Number of sessions delivered for each program
Time frame: Baseline, 9 months (immediate post intervention)
Length of the sessions delivered
Time frame: Baseline, 9 months (immediate post intervention)
Individual-level attendance data for programs delivered
Time frame: Baseline, 9 months (immediate post intervention)
Body mass index (BMI)
Time frame: Baseline, 9 months (immediate post intervention)
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.
Concentration of subdermal carotenoids
Time frame: Baseline, 9 months (immediate 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.
Physical fitness capacity estimation
Time frame: Baseline, 9 months (immediate 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.
7 secondary outcomes
Blood pressure level
Time frame: Baseline, 9 months (immediate post intervention)
Concentration of blood glucose
Time frame: Baseline, 9 months (immediate post intervention)
Waist circumference
Time frame: Baseline, 9 months (immediate post intervention)
Concentration of HDL cholesterol
Time frame: Baseline, 9 months (immediate post intervention)
Concentration of serum triglycerides
Time frame: Baseline, 9 months (immediate post intervention)
Height
Time frame: Baseline, 9 months (immediate post intervention)
Weight
Time frame: Baseline, 9 months (immediate post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 41246086Szeszulski J, Schaefers A, De Mello GT, Gardner J, George A, MacMillan Uribe A, Rethorst CD, Seguin-Fowler RA, Xin L. Design and methodology of a cluster randomized factorial trial to optimize implementation strategies for the Healthy School Recognized Campus initiative. Front Public Health. 2025 Oct 30;13:1652485. doi: 10.3389/fpubh.2025.1652485. eCollection 2025.
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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. This study is not recruiting at the moment.
Jacob Szeszulski, PhD principal investigator
Texas A&M AgriLife
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, Enhanced Resources and Enhanced Engagement 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?
The sponsor lists 0 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of metabolic syndrome (MetS) (time frame: Baseline, 9 months (immediate post intervention)). The study lists 9 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 NCT05977959, 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 12 Sep 2025.