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

Cardiovascular Diseases Clinical Trial

— HSRC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977959
• Other study ID #: AHA HSRC
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Texas A&M University
• Contact: Jacob Szeszulski, PhD
• Phone: 972-952-9202
• Email: jacob.szeszulski[@]ag.tamu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

School 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Nutrition
• Physical Activity

Intervention

Behavioral:
• Mentoring Program
Schools in this group will participate in meetings and discussion boards and receive newsletters to help with program implementation.
• Enhanced Resources
Schools in this group will receive extra resources such as program incentives to aid in program implementation.
• Enhanced Engagement
Schools in this group will participate in program contests to aid program implementation.

Locations

Country	Name	City	State
United States	Texas A&M AgriLife Dallas Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of metabolic syndrome (MetS)	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: Abdominal obesity: waist circumference >90th percentile for child's sex and age; High blood pressure: systolic blood pressure =130 mm Hg or diastolic blood pressure =90 mmHg); High blood glucose: blood glucose =5.6 mmol/L or known diabetes; Low HDL cholesterol: HDL cholesterol <1.03 mmol/L; High triglyceride level: Triglyceride level = 1.7mmol/L	Baseline, 9 months (immediate post intervention)
Primary	Change in the number of MetS risk factors	Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors); Measures to determine MetS risk factors: Abdominal obesity: waist circumference >90th percentile for child's sex and age; High blood pressure: systolic blood pressure =130 mm Hg or diastolic blood pressure =90 mmHg); High blood glucose: blood glucose =5.6 mmol/L or known diabetes; Low HDL cholesterol: HDL cholesterol <1.03 mmol/L; High triglyceride level: Triglyceride level = 1.7mmol/L	Baseline, 9 months (immediate post intervention)
Primary	Number of programs schools delivered (in addition to Walk Across Texas)		Baseline, 9 months (immediate post intervention)
Primary	Number of sessions delivered for each program		Baseline, 9 months (immediate post intervention)
Primary	Length of the sessions delivered		Baseline, 9 months (immediate post intervention)
Primary	Individual-level attendance data for programs delivered		Baseline, 9 months (immediate post intervention)
Primary	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 (immediate post intervention)
Primary	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.	Baseline, 9 months (immediate post intervention)
Primary	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.	Baseline, 9 months (immediate post intervention)
Secondary	Blood pressure level	Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer.	Baseline, 9 months (immediate post intervention)
Secondary	Concentration of blood glucose	Glucose will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention)
Secondary	Waist circumference	Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure.	Baseline, 9 months (immediate post intervention)
Secondary	Concentration of HDL cholesterol	HDL-C will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention)
Secondary	Concentration of serum triglycerides	Triglycerides will be measured using a portable CardioChek Plus analyzer to assess a single capillary blood sample following an overnight fast.	Baseline, 9 months (immediate post intervention)
Secondary	Height	Height will be measured using a stadiometer in inches.	Baseline, 9 months (immediate post intervention)
Secondary	Weight	Weight will be measured with a scale in pounds.	Baseline, 9 months (immediate post intervention)