Clinical trial NCT05977959: Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
Official title: Optimizing the Impact of the Healthy School Recognized Campus Program on Youth's CVD Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Physical Activity
Nutrition
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-08-07
Enrollment: 400
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence or absence of metabolic syndrome (MetS)
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Change in the number of MetS risk factors
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Number of programs schools delivered (in addition to Walk Across Texas)
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Number of sessions delivered for each program
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Length of the sessions delivered
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Individual-level attendance data for programs delivered
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Body mass index (BMI)
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Concentration of subdermal carotenoids
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Physical fitness capacity estimation
timeFrame: Baseline, 9 months (immediate post intervention)
Secondary outcomes:
measure: Blood pressure level
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Concentration of blood glucose
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Waist circumference
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Concentration of HDL cholesterol
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Concentration of serum triglycerides
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Height
timeFrame: Baseline, 9 months (immediate post intervention)
measure: Weight
timeFrame: Baseline, 9 months (immediate post intervention)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas A&M AgriLife Dallas Center
state: Texas
Study officials:
affiliation: Texas A&M AgriLife
name: Jacob Szeszulski, PhD
role: PRINCIPAL_INVESTIGATOR
References: