Sleep QuantityNCT04997603
Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
A study testing Accelerometer in people with Sleep Quantity and Sleep Efficiency, run by PepsiCo Global R&D at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quantity, Sleep Efficiency
- What is being tested?
- Accelerometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Oct 2020to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Gatorade Sports Science Institute (GSSI)
Barrington, Illinois, 60010
Belton High School
Belton, Texas, 76513
McGregor High School
McGregor, Texas, 76657
Lake Belton High School
Temple, Texas, 76502
About this study
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.
- Conditions
- Sleep Quantity, Sleep Efficiency
- Being tested
- Accelerometer
- Keywords
- sleep, adolescent, Fitbit, accelerometer, athlete, stress, students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerOther
Fitbit brand
| Study group | Role | What they receive |
|---|---|---|
| Athletes wearing an accelerometer continuously for 2 weeks | Other | High school students: 50% male, 50% female Receives: Other: Accelerometer |
| Non-athletes wearing an accelerometer continuously for 2 weeks | Other | High school students: 50% male, 50% female Receives: Other: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitbit mean sleep quantity
Measured in minutes. More minutes are better.
Measured: 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.
Measured: Worn for two continuous weeks
Secondary outcomes (4)
Fitbit steps counted
Physical activity measure. More steps are better.
Measured: Two weeks of continuous Fitbit monitoring
Subjective sleep (PSQI) scores
Subjective sleep PSQI (Pittsburgh Sleep Quality Index) scores (0-21). Higher scores are worse.
Measured: Two weeks of continuous Fitbit monitoring
Subjective stress (PSS) scores
Perceived stress PSS (Perceived Stress Scale) scores (0-40). Higher scores are worse.
Measured: Two weeks of continuous Fitbit monitoring
Dietary REAP
Rapid Eating Assessment for Patients (REAP) scores (30-89). Higher scores are better.
Measured: Two weeks of continuous Fitbit monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start16 Oct 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QuantityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corey T Ungaro, Principal investigator, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997603
- Sponsor's protocol ID
- PEP-1914
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Physical Activity, and Dietary Habits Among High School Student-athletes and Non-athletes During an Academic Semester
- ClinicalTrials.gov ID
- NCT04997603
- Acronym / sponsor ID
- PEP-1914
- Conditions
- Sleep Quantity, Sleep Efficiency
- Keywords
- sleep, adolescent, Fitbit, accelerometer, athlete, stress, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Athletes wearing an accelerometer continuously for 2 weeks | Other | Other: AccelerometerHigh school students: 50% male, 50% female |
| Non-athletes wearing an accelerometer continuously for 2 weeks | Other | Other: AccelerometerHigh school students: 50% male, 50% female |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerFitbit brand | Other | Athletes wearing an accelerometer continuously for 2 weeks, Non-athletes wearing an accelerometer continuously for 2 weeks |
Primary outcome
Fitbit mean sleep quantity
Time frame: Worn for two continuous weeks
Measured in minutes. More minutes are better.
Fitbit mean sleep efficiency
Time frame: Worn for two continuous weeks
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.
4 secondary outcomes
Fitbit steps counted
Time frame: Two weeks of continuous Fitbit monitoring
Subjective sleep (PSQI) scores
Time frame: Two weeks of continuous Fitbit monitoring
Subjective stress (PSS) scores
Time frame: Two weeks of continuous Fitbit monitoring
Dietary REAP
Time frame: Two weeks of continuous Fitbit monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Sleep Quantity
Not yet recruiting
Assessing the Effect of Cool Roofs on Health Using Smartwatches in Colima, Mexico
Heart Rate, All-day Steps
Active, not recruiting
Assessing the Effect of Cool Roofs on Health Using Smartwatches
Heart Rate, All-day Steps
Not yet recruiting
Assessing the Effect of Cool Roofs on Health Using Smartwatches in Ouagadougou, Burkina Faso
Heart Rate, All-day Steps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey T Ungaro principal investigator
PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer in people with Sleep Quantity and Sleep Efficiency, run by PepsiCo Global R&D at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitbit mean sleep quantity (time frame: Worn for two continuous weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.