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

ConditionsCardiovascular Diseases Physical Activity Nutrition

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age8-16

SponsorTexas A&M University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

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.

Treatment groups

900 Participants

are divided into 4 treatment groups

Group A: HSRC + Standard ImplementationNo intervention 0 interventions

Group B: HSRC + Mentoring ProgramExperimental treatment 1 intervention

Group C: Waitlist Control + HSRC + Standard ImplementationExperimental treatment 1 intervention

Group D: Waitlist Control + HSRC + Mentoring ProgramExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.)

Time frame

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.)

Time frame

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.)

Time frame

Baseline, 9 months

Secondary outcomes

Concentration of subdermal carotenoids

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.

Time frame

Baseline, 9 months

Accelerometer-derived physical activity estimation

Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA.

Time frame

Baseline, 9 months

Number of students reached

Time frame

Baseline, 9 months

Total program dosage delivered

Time frame

Baseline, 9 months

Other outcomes

Blood pressure

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

Time frame

Baseline, 9 months

Physical fitness capacity estimation

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.

Time frame

Baseline, 9 months

Waist circumference

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

Time frame

Baseline, 9 months