Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mentoring program, Waitlist.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Physical Activity, Nutrition. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Mentoring program
Schools in this group will participate in meetings and receive newsletters to help with program implementation. - Behavioral Waitlist
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.
Primary outcome measures
- Body mass index (BMI) [Time frame: Baseline, 9 months]
- Acceptability of the HSRC program [Time frame: Baseline, 9 months]
- Appropriateness of the HSRC program [Time frame: Baseline, 9 months]
- Feasibility of the HSRC program [Time frame: Baseline, 9 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Texas A&M AgriLife Dallas Center — Dallas
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. PMID 41645239
Identifiers
NCT: NCT07079995 · HSRC DRCT STUDY2025-0650