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

Not Applicable

Not yet recruiting

• Conditions: Cardiovascular Diseases; Physical Activity; Nutrition

• Registration Number: NCT07079995
• Lead Sponsor: Texas A&M University

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 of their current physical activity and/or healthy eating programs, and they 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, we 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, we will compare outcomes in 10 Texas schools that receive the mentoring program with 10 that receive standard implementation.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-09-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Acceptability of the HSRC program	Baseline, 9 months	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.)
Appropriateness of the HSRC program	Baseline, 9 months	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.)
Feasibility of the HSRC program	Baseline, 9 months	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.)
Body mass index (BMI)	Baseline, 9 months	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.

Secondary Outcome Measures

Name	Time	Method
Concentration of subdermal carotenoids	Baseline, 9 months	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.
Accelerometer-derived physical activity estimation	Baseline, 9 months	Physical 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 reached	Baseline, 9 months
Total program dosage delivered	Baseline, 9 months

Trial Locations

Locations (1)

Texas A&M AgriLife Dallas Center; 🇺🇸 Dallas, Texas, United States