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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Physical Activity; Nutrition
• Intervention / Treatment: Behavioral: Mentoring program; Behavioral: Waitlist

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 Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Szeszulski; Phone Number: 972-952-9202; Email: jacob.szeszulski@agnet.tamu.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75252
      • Recruiting
      • Texas A&M AgriLife Dallas Center
      • Contact: Allyson Schaefers; Phone Number: 9729529629; Email: allyson.schaefers@ag.tamu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Waitlist Control + HSRC + Standard Implementation; Participants in this group will receive HSRC with standard implementation one year after enrollment. [schools (n=5), participants (n=225)]	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.
Experimental: Waitlist Control + HSRC + Mentoring Program; Participants in this group will receive HSRC with the mentoring program one year after enrollment. [schools (n=5), participants (n=225)]	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.
No Intervention: HSRC + Standard Implementation; Participants in this group will receive HSRC in the first year of enrollment with standard implementation. [schools (n=5), participants (n=225)]
Experimental: HSRC + Mentoring Program; Participants in this group will receive HSRC in the first year of enrollment with the mentoring program. [schools (n=5), participants (n=225)]	Behavioral: Mentoring program; Schools in this group will participate in meetings and receive newsletters to help with program implementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 9 months
Number of students reached		Baseline, 9 months
Total program dosage delivered		Baseline, 9 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.	Baseline, 9 months
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.	Baseline, 9 months
Waist circumference	Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.	Baseline, 9 months

Collaborators and Investigators

• Sponsor: Texas A&M University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Jacob Szeszulski, Institute for Advancing Health through Agriculture

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: July 14, 2025
• First Posted (Actual): July 23, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Cardiovascular Diseases; Motor Activity; Organization and Administration; Health Services Administration; Appointments and Schedules; Waiting Lists
• Other Study ID Numbers: HSRC DRCT STUDY2025-0650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: start: 3/31/2028
• IPD Sharing Access Criteria: Researchers can access through ClinicalTrials.gov or Open Science Framework (general)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No