NCT07079995

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
26mo left

Started Sep 2025

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

July 1, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

October 7, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

July 1, 2025

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Concentration of subdermal carotenoids

    Baseline, 9 months

  • Accelerometer-derived physical activity estimation

    Baseline, 9 months

  • Number of students reached

    Baseline, 9 months

  • Total program dosage delivered

    Baseline, 9 months

Other Outcomes (3)

  • Blood pressure

    Baseline, 9 months

  • Physical fitness capacity estimation

    Baseline, 9 months

  • Waist circumference

    Baseline, 9 months

Study Arms (4)

HSRC + Standard Implementation

NO INTERVENTION

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

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

Waitlist Control + HSRC + Standard Implementation

EXPERIMENTAL

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

Behavioral: Waitlist

Waitlist Control + HSRC + Mentoring Program

EXPERIMENTAL

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

Behavioral: Mentoring programBehavioral: Waitlist

Interventions

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

HSRC + Mentoring ProgramWaitlist Control + HSRC + Mentoring Program
WaitlistBEHAVIORAL

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 ProgramWaitlist Control + HSRC + Standard Implementation

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M AgriLife Dallas Center

Dallas, Texas, 75252, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Jacob Szeszulski

    Institute for Advancing Health through Agriculture

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 23, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

October 7, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Time Frame
start: 3/31/2028
Access Criteria
Researchers can access through ClinicalTrials.gov or Open Science Framework (general)

Locations