Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
1 other identifier
interventional
900
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2025
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
October 7, 2025
June 1, 2025
2.8 years
July 1, 2025
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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.
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.)
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.)
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.)
Baseline, 9 months
Secondary Outcomes (4)
Concentration of subdermal carotenoids
Baseline, 9 months
Accelerometer-derived physical activity estimation
Baseline, 9 months
Number of students reached
Baseline, 9 months
Total program dosage delivered
Baseline, 9 months
Other Outcomes (3)
Blood pressure
Baseline, 9 months
Physical fitness capacity estimation
Baseline, 9 months
Waist circumference
Baseline, 9 months
Study Arms (4)
HSRC + Standard Implementation
NO INTERVENTIONParticipants in this group will receive HSRC in the first year of enrollment with standard implementation. \[schools (n=5), participants (n=225)\]
HSRC + Mentoring Program
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants in this group will receive HSRC with standard implementation one year after enrollment. \[schools (n=5), participants (n=225)\]
Waitlist Control + HSRC + Mentoring Program
EXPERIMENTALParticipants in this group will receive HSRC with the mentoring program one year after enrollment. \[schools (n=5), participants (n=225)\]
Interventions
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.
Eligibility Criteria
You may qualify if:
- located in Central and East Texas
- Public school
- enrolled in the 4th, 5th, 6th, 7th, 8th, or 9th grade
- able to read, speak, and write in English
You may not qualify if:
- any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas A&M Universitylead
- American Heart Associationcollaborator
Study Sites (1)
Texas A&M AgriLife Dallas Center
Dallas, Texas, 75252, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Szeszulski
Institute for Advancing Health through Agriculture
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2025
First Posted
July 23, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
October 7, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- start: 3/31/2028
- Access Criteria
- Researchers can access through ClinicalTrials.gov or Open Science Framework (general)
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.