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

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PepsiCo

Status

Completed

Conditions

Sleep Quantity
Sleep Efficiency

Treatments

Other: Accelerometer

Study type

Interventional

Funder types

Industry

Identifiers

NCT04997603
PEP-1914

Details and patient eligibility

About

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.

Full description

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.

Enrollment

96 patients

Sex

All

Ages

15 to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

96 participants in 2 patient groups

Athletes wearing an accelerometer continuously for 2 weeks
Other group
Description:
High school students: 50% male, 50% female
Treatment:
Other: Accelerometer
Non-athletes wearing an accelerometer continuously for 2 weeks
Other group
Description:
High school students: 50% male, 50% female
Treatment:
Other: Accelerometer

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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