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

Sleep Efficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997603
• Other study ID #: PEP-1914
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: August 2021
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 20, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Efficiency

Intervention

Other:
• Accelerometer
Fitbit brand

Locations

Country	Name	City	State
United States	Gatorade Sports Science Institute (GSSI)	Barrington	Illinois
United States	Belton High School	Belton	Texas
United States	McGregor High School	McGregor	Texas
United States	Lake Belton High School	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fitbit mean sleep quantity	Measured in minutes. More minutes are better.	Worn for two continuous weeks
Primary	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	Fitbit steps counted	Physical activity measure. More steps are better.	Two weeks of continuous Fitbit monitoring
Secondary	Subjective sleep (PSQI) scores	Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.	Two weeks of continuous Fitbit monitoring
Secondary	Subjective stress (PSS) scores	Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.	Two weeks of continuous Fitbit monitoring
Secondary	Dietary REAP	Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.	Two weeks of continuous Fitbit monitoring