Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors

Not Applicable

Recruiting

• Conditions: Nutrition; Physical Activity; Cardiovascular Diseases
• Interventions: Behavioral: Mentoring Program; Behavioral: Enhanced Resources; Behavioral: Enhanced Engagement

• Registration Number: NCT05977959
• Lead Sponsor: Texas A&M University

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 improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.

Detailed Description

The investigators will conduct a group randomized factorial trial using the Multiphase Optimization STrategy (MOST) framework to evaluate the impact (i.e., implementation and effectiveness) of three implementation strategies on program implementation and youth's cardiovascular disease risk. HSRC is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs.

Elementary schools in North and East Texas (n=16) of similar socio-economic status will be randomized at baseline to receive either 3, 2, 1, or no strategies to support HSRC program implementation. All schools will participate in HSRC during the full school year.

The investigators hypothesize that one strategy will result in significantly greater HSRC implementation and effectiveness than the other strategies tested.

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-07
• Study Start: 2023-09-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• located in North and East Texas
• Public elementary school

Student Inclusion Criteria"

• at least 10 years old by September 1, 2023 (2024 for the 2024-2025 school year)
• enrolled in the 5th or 6th 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Mentoring + Enhanced Resources	Mentoring Program	Participants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Resources + Enhanced Engagement	Enhanced Resources	Participants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Engagement	Enhanced Engagement	Participants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Resources + Enhanced Engagement	Enhanced Engagement	Participants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Mentoring Program	Mentoring Program	Participants in this group will receive the Mentoring Program strategy in addition to Healthy School Recognized Campus.
Enhanced Resources	Enhanced Resources	Participants in this group will receive the Enhanced Resources strategy in addition to Healthy School Recognized Campus.
Enhanced Engagement	Enhanced Engagement	Participants in this group will receive the Enhanced Engagement strategy in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Resources	Enhanced Resources	Participants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Engagement	Mentoring Program	Participants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Enhanced Resources + Enhanced Engagement	Enhanced Resources	Participants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Enhanced Resources + Enhanced Engagement	Enhanced Engagement	Participants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.
Mentoring + Enhanced Resources + Enhanced Engagement	Mentoring Program	Participants in this group will receive the Mentoring Program, Enhanced Resources, and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Primary Outcome Measures

Name	Time	Method
Length of the sessions delivered	Baseline, 9 months (immediate post intervention)
Individual-level attendance data for programs delivered	Baseline, 9 months (immediate post intervention)
Concentration of subdermal carotenoids	Baseline, 9 months (immediate post intervention)	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.
Change in the number of MetS risk factors	Baseline, 9 months (immediate post intervention)	Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors); Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age; 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg); 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes; 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L; 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Body mass index (BMI)	Baseline, 9 months (immediate post intervention)	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.
Presence or absence of metabolic syndrome (MetS)	Baseline, 9 months (immediate post intervention)	MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels.; MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors); Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age; 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg); 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes; 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L; 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L
Number of programs schools delivered (in addition to Walk Across Texas)	Baseline, 9 months (immediate post intervention)
Physical fitness capacity estimation	Baseline, 9 months (immediate post intervention)	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.
Number of sessions delivered for each program	Baseline, 9 months (immediate post intervention)

Secondary Outcome Measures

Name	Time	Method
Waist circumference	Baseline, 9 months (immediate post intervention)	Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.
Blood pressure level	Baseline, 9 months (immediate post intervention)	Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.
Concentration of HDL cholesterol	Baseline, 9 months (immediate post intervention)	HDL-C will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.
Concentration of serum triglycerides	Baseline, 9 months (immediate post intervention)	Triglycerides will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.
Height	Baseline, 9 months (immediate post intervention)	Height will be measured using a stadiometer in inches.
Weight	Baseline, 9 months (immediate post intervention)	Weight will be measured with a scale in pounds.
Concentration of blood glucose	Baseline, 9 months (immediate post intervention)	Glucose will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.

Trial Locations

Locations (1)

Texas A&M AgriLife Dallas Center; 🇺🇸 Dallas, Texas, United States