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

NCT04997603 | Completed

• 1 other identifier: PEP-1914
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep Quantity; Sleep Efficiency

Keywords

sleep; adolescent; Fitbit; accelerometer; athlete; stress; students

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Fitbit steps counted

  Two weeks of continuous Fitbit monitoring

• Subjective sleep (PSQI) scores

  Two weeks of continuous Fitbit monitoring

• Subjective stress (PSS) scores

  Two weeks of continuous Fitbit monitoring

• Dietary REAP

  Two weeks of continuous Fitbit monitoring

Study Arms (2)

Athletes wearing an accelerometer continuously for 2 weeks

OTHER

High school students: 50% male, 50% female

Other: Accelerometer

Non-athletes wearing an accelerometer continuously for 2 weeks

OTHER

High school students: 50% male, 50% female

Other: Accelerometer

Interventions

Accelerometer OTHER

Fitbit brand

Athletes wearing an accelerometer continuously for 2 weeks; Non-athletes wearing an accelerometer continuously for 2 weeks

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (4)

Gatorade Sports Science Institute (GSSI)

Barrington, Illinois, 60010, United States

Location

Belton High School

Belton, Texas, 76513, United States

Location

McGregor High School

McGregor, Texas, 76657, United States

Location

Lake Belton High School

Temple, Texas, 76502, United States

Location

Study Officials

• Corey T Ungaro

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 9, 2021
• Study Start: October 16, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)