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

NCT ID: NCT07079995

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-06-30

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.

Conditions

Cardiovascular Diseases; Physical Activity; Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HSRC + Standard Implementation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

HSRC + Mentoring Program

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

Group Type: EXPERIMENTAL

Mentoring program

Intervention Type: BEHAVIORAL

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

Waitlist Control + HSRC + Standard Implementation

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

Group Type: EXPERIMENTAL

Waitlist

Intervention Type: BEHAVIORAL

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.

Waitlist Control + HSRC + Mentoring Program

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

Group Type: EXPERIMENTAL

Mentoring program

Intervention Type: BEHAVIORAL

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

Waitlist

Intervention Type: BEHAVIORAL

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.

Interventions

Mentoring program

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• located in Central and East Texas
• Public school

• enrolled in the 4th, 5th, 6th, 7th, 8th, or 9th grade
• able to read, speak, and write in English

Exclusion Criteria

• any motor or cognitive impairments or other health conditions that would prevent them from completing a physical assessment

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Szeszulski

Role: PRINCIPAL_INVESTIGATOR

Institute for Advancing Health through Agriculture

Locations

Texas A&M AgriLife Dallas Center

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacob Szeszulski

Role: CONTACT

jacob.szeszulski@agnet.tamu.edu

972-952-9202

Facility Contacts

Allyson Schaefers

Role: primary

allyson.schaefers@ag.tamu.edu

9729529629

Other Identifiers

HSRC DRCT STUDY2025-0650

Identifier Type: -

Identifier Source: org_study_id