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.

Study Overview

• Status: Completed
• Conditions: Sleep Quantity; Sleep Efficiency
• Intervention / Treatment: Other: Accelerometer

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Gatorade Sports Science Institute (GSSI)
  • Texas
    • Belton, Texas, United States, 76513
      • Belton High School
    • McGregor, Texas, United States, 76657
      • McGregor High School
    • Temple, Texas, United States, 76502
      • Lake Belton High School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Athletes wearing an accelerometer continuously for 2 weeks; High school students: 50% male, 50% female	Other: Accelerometer; Fitbit brand
Other: Non-athletes wearing an accelerometer continuously for 2 weeks; High school students: 50% male, 50% female	Other: Accelerometer; Fitbit brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitbit mean sleep quantity	Measured in minutes. More minutes are better.	Worn for two continuous weeks
Fitbit mean sleep efficiency	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.	Worn for two continuous weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitbit steps counted	Physical activity measure. More steps are better.	Two weeks of continuous Fitbit monitoring
Subjective sleep (PSQI) scores	Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.	Two weeks of continuous Fitbit monitoring
Subjective stress (PSS) scores	Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.	Two weeks of continuous Fitbit monitoring
Dietary REAP	Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.	Two weeks of continuous Fitbit monitoring

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Corey T Ungaro, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: sleep; adolescent; stress; students; accelerometer; Fitbit; athlete
• Other Study ID Numbers: PEP-1914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No