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临床试验/NCT04997603
NCT04997603已完成不适用

Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester

PepsiCo Global R&D8 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年10月16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
96
试验地点
8
主要终点
Fitbit mean sleep quantity

研究概览

简要总结

Adolescent's poor sleep habits have been linked to adverse outcomes. Recent advances in activity tracking have provided researchers with cost-effective and non-invasive measurements of sleep in a free-living environment. The primary objective is to determine the mean differences in Fitbit accelerometer sleep quantity (mins) between High School student-athletes and non-athletes during a competitive academic semester over continuous monitoring for two weeks.

详细描述

Secondary objectives are to measure and determine:

  • If a relationship exist between self-reported Pittsburgh Sleep Quality Index (PSQI) sleep scores and Perceived Stress Scale (PSS) scores compared to mean Fitbit accelerometer sleep quantity and efficiency (sleep quality) based on heart rate, time awake or restless over two weeks
  • If dietary habits have a significantly correlated relationship to subject group, sleep quantity, sleep efficiency and steps/day
  • If mean differences exist in Fitbit steps counted between student-athletes and non-athletes over two weeks
  • If a relationship exists between mean Fitbit accelerometer steps counted and mean sleep quantity and efficiency over two weeks

All Fitbits are monitored remotely by the Principal investigator. This is a fully remote study (no physical study sites). Participants are recruited from 3 high schools (IRB approved). Consent, study forms and other e-mail communication and texting is directly between the participant and the Principal Investigator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • High-school student-athletes and non-athletes ages 15-18 y
  • Enrolled in at least 6 academic credit hours from the same high school
  • Willing and able to wear wrist-worn Fitbit continuously for 14 days
  • Parental consent will be needed for minors (<18 years old)
  • Student-athletes need to be competing in a high school recognized sport during the study period

排除标准

  • Individual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project/study protocol, which might confound the interpretation of the project/study results or put the person at undue risk
  • Those with a medical history that would interfere with the results of this study.
  • Under the care of a physician
  • Skin sensitivities
  • Sleep disorders
  • Using prescription medications that would impact sleep
  • Drug or alcohol user
  • Not able to wear wrist-worn Fitbit continuously for 14 days
  • Non-athletes must not be in an organized sport
  • Lack of proficiency in English
  • Lack of proficiency or access to the internet and email address
  • Are not employed by, or have a parent, guardian or other immediate family member employed by, a company that manufactures any products that compete with any Gatorade products. If you are unsure if a company would be considered a competitor to Gatorade, please let the study investigator know the name of the other company and the nature of your relationship to that company before you sign this form
  • No participation in another clinical trial within the past 30 days, and no participation in a PepsiCo protocol within the past 6 months.

结局指标

主要结局

Fitbit mean sleep quantity

时间窗: Worn for two continuous weeks

Measured in minutes. More minutes are better.

Fitbit mean sleep efficiency

时间窗: Worn for two continuous weeks

Measured as a percentage (0-100% score representing sleep quality based on heart rate, time awake or restless, and sleep stages). Higher percentage is better.

次要结局

  • Fitbit steps counted(Two weeks of continuous Fitbit monitoring)
  • Subjective sleep (PSQI) scores(Two weeks of continuous Fitbit monitoring)
  • Subjective stress (PSS) scores(Two weeks of continuous Fitbit monitoring)
  • Dietary REAP(Two weeks of continuous Fitbit monitoring)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (8)

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