NCT05977959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 12, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

July 24, 2023

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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: 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

    Baseline, 9 months (immediate post intervention)

  • 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: 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

    Baseline, 9 months (immediate post intervention)

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

    Baseline, 9 months (immediate post intervention)

  • Number of sessions delivered for each program

    Baseline, 9 months (immediate post intervention)

  • Length of the sessions delivered

    Baseline, 9 months (immediate post intervention)

  • Individual-level attendance data for programs delivered

    Baseline, 9 months (immediate post intervention)

  • 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)

  • 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)

  • 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 Outcomes (7)

  • Blood pressure level

    Baseline, 9 months (immediate post intervention)

  • Concentration of blood glucose

    Baseline, 9 months (immediate post intervention)

  • Waist circumference

    Baseline, 9 months (immediate post intervention)

  • Concentration of HDL cholesterol

    Baseline, 9 months (immediate post intervention)

  • Concentration of serum triglycerides

    Baseline, 9 months (immediate post intervention)

  • +2 more secondary outcomes

Study Arms (8)

Mentoring Program

EXPERIMENTAL

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

Behavioral: Mentoring Program

Enhanced Resources

EXPERIMENTAL

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

Behavioral: Enhanced Resources

Enhanced Engagement

EXPERIMENTAL

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

Behavioral: Enhanced Engagement

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.

Mentoring + Enhanced Resources

EXPERIMENTAL

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

Behavioral: Mentoring ProgramBehavioral: Enhanced Resources

Mentoring + Enhanced Engagement

EXPERIMENTAL

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

Behavioral: Mentoring ProgramBehavioral: Enhanced Engagement

Enhanced Resources + Enhanced Engagement

EXPERIMENTAL

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

Behavioral: Enhanced ResourcesBehavioral: Enhanced Engagement

Mentoring + Enhanced Resources + Enhanced Engagement

EXPERIMENTAL

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

Behavioral: Mentoring ProgramBehavioral: Enhanced ResourcesBehavioral: Enhanced Engagement

Interventions

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

Mentoring + Enhanced EngagementMentoring + Enhanced ResourcesMentoring + Enhanced Resources + Enhanced EngagementMentoring Program

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

Enhanced ResourcesEnhanced Resources + Enhanced EngagementMentoring + Enhanced ResourcesMentoring + Enhanced Resources + Enhanced Engagement

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

Enhanced EngagementEnhanced Resources + Enhanced EngagementMentoring + Enhanced EngagementMentoring + Enhanced Resources + Enhanced Engagement

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • located in North and East Texas
  • Public elementary school
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M AgriLife Dallas Center

Dallas, Texas, 75252, United States

Location

Related Publications (1)

  • Szeszulski J, Schaefers A, De Mello GT, Gardner J, George A, MacMillan Uribe A, Rethorst CD, Seguin-Fowler RA, Xin L. Design and methodology of a cluster randomized factorial trial to optimize implementation strategies for the Healthy School Recognized Campus initiative. Front Public Health. 2025 Oct 30;13:1652485. doi: 10.3389/fpubh.2025.1652485. eCollection 2025.

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jacob Szeszulski, PhD

    Texas A&M AgriLife

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 7, 2023

Study Start

September 13, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

September 12, 2025

Record last verified: 2025-06

Locations