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OpenTrials
Completed

NCT Number: NCT04997603

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

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.

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Key information

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gatorade Sports Science Institute (GSSI), Barrington, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Pregnant
  • Smoker
  • 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.

Treatment and study plan

Accelerometer

Other

Fitbit brand

Primary outcomes

  1. Fitbit mean sleep quantity

    Time frame: Worn for two continuous weeks

    Measured in minutes. More minutes are better.

  2. Fitbit mean sleep efficiency

    Time frame: 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.

Secondary outcomes

  1. Fitbit steps counted

    Time frame: Two weeks of continuous Fitbit monitoring

    Physical activity measure. More steps are better.

  2. Subjective sleep (PSQI) scores

    Time frame: Two weeks of continuous Fitbit monitoring

    Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.

  3. Subjective stress (PSS) scores

    Time frame: Two weeks of continuous Fitbit monitoring

    Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.

  4. Dietary REAP

    Time frame: Two weeks of continuous Fitbit monitoring

    Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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