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

NCT ID: NCT04997603

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2020-12-20

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.

Conditions

Sleep Quantity; Sleep Efficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Athletes wearing an accelerometer continuously for 2 weeks

High school students: 50% male, 50% female

Group Type: OTHER

Accelerometer

Intervention Type: OTHER

Fitbit brand

Non-athletes wearing an accelerometer continuously for 2 weeks

High school students: 50% male, 50% female

Group Type: OTHER

Accelerometer

Intervention Type: OTHER

Fitbit brand

Interventions

Accelerometer

Fitbit brand

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PepsiCo Global R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corey T Ungaro

Role: PRINCIPAL_INVESTIGATOR

PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)

Locations

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, United States

Countries

United States

Other Identifiers

PEP-1914

Identifier Type: -

Identifier Source: org_study_id