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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04997603
Enrollment
96
Registered
2021-08-09
Start date
2020-10-16
Completion date
2020-12-20
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Efficiency, Sleep Quantity

Keywords

sleep, adolescent, Fitbit, accelerometer, athlete, stress, students

Brief summary

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.

Detailed 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.

Interventions

OTHERAccelerometer

Fitbit brand

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Fitbit accelerometers are distributed to both groups, student athletes and non-athletes who continue to live their lives as usual during the 2 week monitoring.

Eligibility

Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. High-school student-athletes and non-athletes ages 15-18 y 2. Enrolled in at least 6 academic credit hours from the same high school 3. Willing and able to wear wrist-worn Fitbit continuously for 14 days 4. Parental consent will be needed for minors (\<18 years old) 5. Student-athletes need to be competing in a high school recognized sport during the study period

Exclusion criteria

1. 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 2. Those with a medical history that would interfere with the results of this study. 3. Under the care of a physician 4. Skin sensitivities 5. Sleep disorders 6. Using prescription medications that would impact sleep 7. Pregnant 8. Smoker 9. Drug or alcohol user 10. Not able to wear wrist-worn Fitbit continuously for 14 days 11. Non-athletes must not be in an organized sport 12. Lack of proficiency in English 13. Lack of proficiency or access to the internet and email address 14. 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 15. No participation in another clinical trial within the past 30 days, and no participation in a PepsiCo protocol within the past 6 months.

Design outcomes

Primary

MeasureTime frameDescription
Fitbit mean sleep quantityWorn for two continuous weeksMeasured in minutes. More minutes are better.
Fitbit mean sleep efficiencyWorn for two continuous weeksMeasured 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

MeasureTime frameDescription
Fitbit steps countedTwo weeks of continuous Fitbit monitoringPhysical activity measure. More steps are better.
Subjective sleep (PSQI) scoresTwo weeks of continuous Fitbit monitoringSubjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.
Subjective stress (PSS) scoresTwo weeks of continuous Fitbit monitoringPerceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.
Dietary REAPTwo weeks of continuous Fitbit monitoringRapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026