Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT04997603
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
18 Years
Study:
NCT04997603
Study Brief:
Protocol Section:
NCT04997603