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临床试验/NCT05977959
NCT05977959已完成不适用

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

Texas A&M University2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2023年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
2
主要终点
Length of the sessions delivered

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Length of the sessions delivered

时间窗: Baseline, 9 months (immediate post intervention)

Individual-level attendance data for programs delivered

时间窗: Baseline, 9 months (immediate post intervention)

Concentration of subdermal carotenoids

时间窗: 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.

Change in the number of MetS risk factors

时间窗: 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: 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

Body mass index (BMI)

时间窗: 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.

Presence or absence of metabolic syndrome (MetS)

时间窗: 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: 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

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

时间窗: Baseline, 9 months (immediate post intervention)

Physical fitness capacity estimation

时间窗: 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.

Number of sessions delivered for each program

时间窗: Baseline, 9 months (immediate post intervention)

次要结局

  • Waist circumference(Baseline, 9 months (immediate post intervention))
  • Blood pressure level(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))
  • Height(Baseline, 9 months (immediate post intervention))
  • Weight(Baseline, 9 months (immediate post intervention))
  • Concentration of blood glucose(Baseline, 9 months (immediate post intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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