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

Sponsor
Texas A&M University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05977959
Collaborator
American Heart Association (Other)
800
8
23

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mentoring Program
  • Behavioral: Enhanced Resources
  • Behavioral: Enhanced Engagement
  • Behavioral: Mentoring + Enhanced Resources
  • Behavioral: Mentoring + Enhanced Engagement
  • Behavioral: Enhanced Resources + Enhanced Engagement
  • Behavioral: Mentoring + Enhanced Resources + Enhanced Engagement
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mentoring Program

Participants in this group will receive the Mentoring Program strategy in addition to Healthy School Recognized Campus.

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

Experimental: Enhanced Resources

Participants in this group will receive the Enhanced Resources strategy in addition to Healthy School Recognized Campus.

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

Experimental: Enhanced Engagement

Participants in this group will receive the Enhanced Engagement strategy in addition to Healthy School Recognized Campus.

Behavioral: Enhanced Engagement
Schools in this group will participate in program contests to aid program implementation.

No Intervention: No Intervention

All schools will participate in the HSRC initiative. The requirements for the initiative are to complete a school-wide walking program, 1 youth, and 1 adult program from a list of available programs that make up the initiative.

Experimental: Mentoring + Enhanced Resources

Participants in this group will receive the Mentoring Program and Enhanced Resources strategies in addition to Healthy School Recognized Campus.

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

Experimental: Mentoring + Enhanced Engagement

Participants in this group will receive the Mentoring Program and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Behavioral: Mentoring + Enhanced Engagement
Schools in this group will participate in meetings and discussion boards and receive newsletters to help with program implementation. They will also participate in program contests to aid program implementation.

Experimental: Enhanced Resources + Enhanced Engagement

Participants in this group will receive the Enhanced Resources and Enhanced Engagement strategies in addition to Healthy School Recognized Campus.

Behavioral: Enhanced Resources + Enhanced Engagement
Schools in this group will receive extra resources such as program incentives to aid in program implementation. They will also participate in program contests to aid program implementation.

Experimental: Mentoring + Enhanced Resources + Enhanced Engagement

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

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

Outcome Measures

Primary Outcome Measures

  1. 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: 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 [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) [Baseline, 9 months (immediate post intervention)]

  4. Number of sessions delivered for each program [Baseline, 9 months (immediate post intervention)]

  5. Length of the sessions delivered [Baseline, 9 months (immediate post intervention)]

  6. Individual-level attendance data for programs delivered [Baseline, 9 months (immediate post intervention)]

  7. 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.

  8. 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.

  9. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Height [Baseline, 9 months (immediate post intervention)]

    Height will be measured using a stadiometer in inches.

  7. Weight [Baseline, 9 months (immediate post intervention)]

    Weight will be measured with a scale in pounds.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Texas A&M University
  • American Heart Association

Investigators

  • Principal Investigator: Jacob Szeszulski, PhD, Texas A&M AgriLife

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Texas A&M University
ClinicalTrials.gov Identifier:
NCT05977959
Other Study ID Numbers:
  • AHA HSRC
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 7, 2023