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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 University1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Presence or absence of metabolic syndrome (MetS)

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
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Mentoring + Enhanced Resources

Experimental

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

干预措施: Mentoring Program (Behavioral)

Enhanced Engagement

Experimental

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

干预措施: Enhanced Engagement (Behavioral)

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 Program

Experimental

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

干预措施: Mentoring Program (Behavioral)

Enhanced Resources

Experimental

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

干预措施: Enhanced Resources (Behavioral)

Mentoring + Enhanced Resources

Experimental

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

干预措施: Enhanced Resources (Behavioral)

Mentoring + Enhanced Engagement

Experimental

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

干预措施: Mentoring Program (Behavioral)

Mentoring + Enhanced Engagement

Experimental

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

干预措施: Enhanced Engagement (Behavioral)

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.

干预措施: Enhanced Resources (Behavioral)

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.

干预措施: Enhanced Engagement (Behavioral)

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.

干预措施: Mentoring Program (Behavioral)

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.

干预措施: Enhanced Resources (Behavioral)

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.

干预措施: Enhanced Engagement (Behavioral)

结局指标

主要结局

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 sessions delivered for each program

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

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.

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.

次要结局

  • Blood pressure level(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))
  • 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 (1)

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