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

Not Applicable

Completed

• Conditions: Sleep Quantity; Sleep Efficiency
• Interventions: Other: Accelerometer

• Registration Number: NCT04997603
• Lead Sponsor: PepsiCo Global R&D

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.

Study Timeline

• Study Start: 2020-10-16
• Primary Completion: 2020-12-20
• Study Completion: 2020-12-20
• Study First Submitted: 2021-07-16
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fitbit mean sleep quantity	Worn for two continuous weeks	Measured in minutes. More minutes are better.
Fitbit mean sleep efficiency	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 Outcome Measures

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

Trial Locations

Locations (4)

Belton High School; 🇺🇸 Belton, Texas, United States

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

Lake Belton High School; 🇺🇸 Temple, Texas, United States

McGregor High School; 🇺🇸 McGregor, Texas, United States