Clinical trial NCT04997603: Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Official title: Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quantity
Sleep Efficiency
Keywords: sleep
adolescent
Fitbit
accelerometer
athlete
stress
students
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 96
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fitbit mean sleep quantity
timeFrame: Worn for two continuous weeks
measure: Fitbit mean sleep efficiency
timeFrame: Worn for two continuous weeks
Secondary outcomes:
measure: Fitbit steps counted
timeFrame: Two weeks of continuous Fitbit monitoring
measure: Subjective sleep (PSQI) scores
timeFrame: Two weeks of continuous Fitbit monitoring
measure: Subjective stress (PSS) scores
timeFrame: Two weeks of continuous Fitbit monitoring
measure: Dietary REAP
timeFrame: Two weeks of continuous Fitbit monitoring
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Gatorade Sports Science Institute (GSSI)
state: Illinois
city: Belton
country: United States
facility: Belton High School
state: Texas
city: McGregor
country: United States
facility: McGregor High School
state: Texas
city: Temple
country: United States
facility: Lake Belton High School
state: Texas
Study officials:
affiliation: PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)
name: Corey T Ungaro
role: PRINCIPAL_INVESTIGATOR
References: