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

Texas A&M University

Status: Enrolling

Conditions: Physical Activity; Nutrition; Cardiovascular Diseases

Treatments: Behavioral: Mentoring program; Behavioral: Waitlist

Study type: Interventional

Funder types: Other

Identifiers

NCT07079995

HSRC DRCT STUDY2025-0650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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900 participants in 4 patient groups

HSRC + Standard Implementation

No Intervention group

Description:

Participants in this group will receive HSRC in the first year of enrollment with standard implementation. \[schools (n=5), participants (n=225)\]

HSRC + Mentoring Program

Experimental group

Description:

Participants in this group will receive HSRC in the first year of enrollment with the mentoring program. \[schools (n=5), participants (n=225)\]

Treatment:

Behavioral: Mentoring program

Waitlist Control + HSRC + Standard Implementation

Experimental group

Description:

Participants in this group will receive HSRC with standard implementation one year after enrollment. \[schools (n=5), participants (n=225)\]

Treatment:

Behavioral: Waitlist

Waitlist Control + HSRC + Mentoring Program

Experimental group

Description:

Participants in this group will receive HSRC with the mentoring program one year after enrollment. \[schools (n=5), participants (n=225)\]

Treatment:

Behavioral: Waitlist

Behavioral: Mentoring program