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Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial

Healthy School Recognized Campus: A Hybrid Type 2 Implementation-Effectiveness Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07079995
Enrollment
900
Registered
2025-07-23
Start date
2025-09-01
Completion date
2028-06-30
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Nutrition, Physical Activity

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.

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

Schools in this group will participate in meetings and receive newsletters to help with program implementation.

BEHAVIORALWaitlist

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.

Sponsors

Texas A&M University
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Body mass index (BMI)Baseline, 9 monthsWeight 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 programBaseline, 9 monthsAcceptability 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 programBaseline, 9 monthsAppropriateness 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 programBaseline, 9 monthsFeasibility 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.)

Secondary

MeasureTime frameDescription
Concentration of subdermal carotenoidsBaseline, 9 monthsThe 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.
Accelerometer-derived physical activity estimationBaseline, 9 monthsPhysical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.
Number of students reachedBaseline, 9 months
Total program dosage deliveredBaseline, 9 months

Countries

United States

Contacts

CONTACTJacob Szeszulski
jacob.szeszulski@agnet.tamu.edu972-952-9202
PRINCIPAL_INVESTIGATORJacob Szeszulski

Institute for Advancing Health through Agriculture

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026