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NCT Number: NCT07079995

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M AgriLife Dallas Center

Dallas, Texas, 75252, United States

Location status: Recruiting

Location contact

Allyson Schaefers

CONTACT

[email protected]

9729529629

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentoring program

Behavioral

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

Waitlist

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.

Primary outcomes

  1. Body mass index (BMI)

    Time frame: 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.

  2. Acceptability of the HSRC program

    Time frame: 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.)

  3. Appropriateness of the HSRC program

    Time frame: 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.)

  4. Feasibility of the HSRC program

    Time frame: 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.)

Secondary outcomes

  1. Concentration of subdermal carotenoids

    Time frame: 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.

  2. Accelerometer-derived physical activity estimation

    Time frame: 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.

  3. Number of students reached

    Time frame: Baseline, 9 months

  4. Total program dosage delivered

    Time frame: Baseline, 9 months

Other outcomes

  1. Blood pressure

    Time frame: Baseline, 9 months

    Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.

  2. Physical fitness capacity estimation

    Time frame: Baseline, 9 months

    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.

  3. Waist circumference

    Time frame: Baseline, 9 months

    Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Szeszulski

CONTACT

[email protected]

972-952-9202

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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