Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-27 @ 1:16 PM
Study NCT ID:
NCT04997603
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Sponsor:
PepsiCo Global R&D
Organization:
Study Overview
Official Title:
Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: