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

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT04997603

Collaborator

(none)

Enrollment

Locations

Arms

2.1

Actual Duration (Months)

Patients Per Site

11.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Quantity Sleep Efficiency	Other: Accelerometer	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 16, 2020

Actual Primary Completion Date :

Dec 20, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gatorade Sports Science Institute (GSSI)	Barrington	Illinois	United States	60010
2	Belton High School	Belton	Texas	United States	76513
3	McGregor High School	McGregor	Texas	United States	76657
4	Lake Belton High School	Temple	Texas	United States	76502