ClinicalTrials.gg
Sign In
CompletedNCT04997603Updated Aug 9, 2021

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

An interventional study of Accelerometer in Sleep Quantity and Sleep Efficiency, sponsored by PepsiCo Global R&D. Completed at 4 sites in United States. Open to participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-09.

Sponsored by PepsiCo Global R&D (part of PepsiCo, Inc.) · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2020, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
15 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Quantity
  • Sleep Efficiency

Keywords

  • sleep
  • adolescent
  • Fitbit
  • accelerometer
  • athlete
  • stress
  • students
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 103 studies on the registry; 8 are open to participants now.

Browse PepsiCo Global R&D studies →All PepsiCo, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Other
    Athletes wearing an accelerometer continuously for 2 weeks

    High school students: 50% male, 50% female

    Other: Accelerometer

  • Other
    Non-athletes wearing an accelerometer continuously for 2 weeks

    High school students: 50% male, 50% female

    Other: Accelerometer

Interventions

  • OtherAccelerometer

    Fitbit brand

06

What researchers measure

Primary outcomes

  1. Fitbit mean sleep quantity

    Measured in minutes. More minutes are better.

    Time frame: Worn for two continuous weeks

  2. 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.

    Time frame: Worn for two continuous weeks

Secondary outcomes

  1. Fitbit steps counted

    Physical activity measure. More steps are better.

    Time frame: Two weeks of continuous Fitbit monitoring

  2. Subjective sleep (PSQI) scores

    Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.

    Time frame: Two weeks of continuous Fitbit monitoring

  3. Subjective stress (PSS) scores

    Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.

    Time frame: Two weeks of continuous Fitbit monitoring

  4. Dietary REAP

    Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.

    Time frame: Two weeks of continuous Fitbit monitoring

07

Study locations

4 sites
  • Gatorade Sports Science Institute (GSSI)
    Barrington, Illinois 60010, United States
  • Belton High School
    Belton, Texas 76513, United States
  • McGregor High School
    McGregor, Texas 76657, United States
  • Lake Belton High School
    Temple, Texas 76502, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in Dec 2020, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2021
First posted
Aug 9, 2021
StartActual
Oct 16, 2020
Primary completionActual
Dec 20, 2020
CompletionActual
Dec 20, 2020
Last update
Aug 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04997603
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Aug 9, 2021
Start date
Oct 16, 2020
Primary completion
Dec 20, 2020
Completion
Dec 20, 2020
Last update
Aug 9, 2021

Study contacts

Corey T Ungaro
principal investigator · PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

PepsiCo Global R&D →

Start the discussion