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Completed

NCT Number: NCT05977959

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

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.

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Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity Nutrition Physical Activity

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas A&M AgriLife Dallas Center

Dallas, Texas, 75252, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Mentoring program

Behavioral

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

Enhanced Resources

Behavioral

Schools in this group will receive extra resources such as program incentives to aid in program implementation.

Enhanced Engagement

Behavioral

Schools in this group will participate in program contests to aid program implementation.

Primary outcomes

  1. Presence or absence of metabolic syndrome (MetS)

    Time frame: 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:

    • 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

  2. Change in the number of MetS risk factors

    Time frame: 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:

    • 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

  3. Number of programs schools delivered (in addition to Walk Across Texas)

    Time frame: Baseline, 9 months (immediate post intervention)

  4. Number of sessions delivered for each program

    Time frame: Baseline, 9 months (immediate post intervention)

  5. Length of the sessions delivered

    Time frame: Baseline, 9 months (immediate post intervention)

  6. Individual-level attendance data for programs delivered

    Time frame: Baseline, 9 months (immediate post intervention)

  7. Body mass index (BMI)

    Time frame: 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.

  8. Concentration of subdermal carotenoids

    Time frame: 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.

  9. Physical fitness capacity estimation

    Time frame: 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.

Secondary outcomes

  1. Blood pressure level

    Time frame: Baseline, 9 months (immediate post intervention)

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

  2. Concentration of blood glucose

    Time frame: 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.

  3. Waist circumference

    Time frame: 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.

  4. Concentration of HDL cholesterol

    Time frame: 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.

  5. Concentration of serum triglycerides

    Time frame: 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.

  6. Height

    Time frame: Baseline, 9 months (immediate post intervention)

    Height will be measured using a stadiometer in inches.

  7. Weight

    Time frame: Baseline, 9 months (immediate post intervention)

    Weight will be measured with a scale in pounds.

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • American Heart Association

Registry information

Acronym: HSRC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2023
Registry last updated
Sep 12, 2025

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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