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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Quantity, Sleep Efficiency

Intervention / Treatment
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* Other: Accelerometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Athletes wearing an accelerometer continuously for 2 weeks<br>High school students: 50% male, 50% female | Other: Accelerometer<br>* Fitbit brand<br>|
| Other: Non-athletes wearing an accelerometer continuously for 2 weeks<br>High school students: 50% male, 50% female | Other: Accelerometer<br>* Fitbit brand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit steps counted | Physical activity measure. More steps are better. | Two weeks of continuous Fitbit monitoring | 
| Subjective sleep (PSQI) scores | Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse. | Two weeks of continuous Fitbit monitoring | 
| Subjective stress (PSS) scores | Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse. | Two weeks of continuous Fitbit monitoring | 
| Dietary REAP | Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better. | Two weeks of continuous Fitbit monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, adolescent, Fitbit, accelerometer, athlete, stress, students