NCT02846077

Brief Summary

The project is designed to document in college undergraduates the relationships among sleep/wake timing and duration, use of mobile phones and other electronic devices, food timing and content, self-reported mood and physiological measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
729

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

4.8 years

First QC Date

July 15, 2016

Last Update Submit

July 9, 2018

Conditions

Healthy Volunteers

Keywords

sleepsocial networksundergraduatesmoodcircadian rhythms

Outcome Measures

Primary Outcomes (2)

  • Timing of sleep and wake

    Timing of self-reported sleep onset and wake onset

    Approximately one month

  • Timing of phone use (e.g., mobile phone calls, text messages, applications and internet use)

    Timing of phone use (e.g, mobile phone calls, text messages, applications and internet use)

    Approximately one month

Secondary Outcomes (7)

  • Mood

    Approximately one month

  • Activity levels

    approximately one month

  • Light exposure levels

    approximately one month

  • Food choice

    approximately one month

  • Circadian phase

    one day

  • +2 more secondary outcomes

Study Arms (1)

College students

College students will be monitored and will complete online surveys, install apps on their mobile phones, wear physiological sensors and provide saliva samples for later assay.

Other: No intervention. Observation only

Interventions

No intervention. Observation onlyOTHER

No intervention. Observation only

College students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

College undergraduates

You may qualify if:

  • undergraduate at institution at which we have permission to perform study
  • owning a mobile device on which the phone app can be installed
  • ability to wear the wrist-worn sensors

You may not qualify if:

  • no travel outside one time zone starting approximately 2 weeks before monitoring begins through end of approximately one month of monitoring.
  • participation in a prior group studied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • Lu S, Stone JE, Klerman EB, McHill AW, Barger LK, Robbins R, Fischer D, Sano A, Czeisler CA, Rajaratnam SMW, Phillips AJK. The organization of sleep-wake patterns around daily schedules in college students. Sleep. 2024 Sep 9;47(9):zsad278. doi: 10.1093/sleep/zsad278.

    PMID: 37930792DERIVED

  • Khalid M, Sano A. Exploiting social graph networks for emotion prediction. Sci Rep. 2023 Apr 13;13(1):6069. doi: 10.1038/s41598-023-32825-9.

    PMID: 37055459DERIVED

  • Fischer D, McHill AW, Sano A, Picard RW, Barger LK, Czeisler CA, Klerman EB, Phillips AJK. Irregular sleep and event schedules are associated with poorer self-reported well-being in US college students. Sleep. 2020 Jun 15;43(6):zsz300. doi: 10.1093/sleep/zsz300.

    PMID: 31837266DERIVED

  • McHill AW, Phillips AJ, Czeisler CA, Keating L, Yee K, Barger LK, Garaulet M, Scheer FA, Klerman EB. Later circadian timing of food intake is associated with increased body fat. Am J Clin Nutr. 2017 Nov;106(5):1213-1219. doi: 10.3945/ajcn.117.161588. Epub 2017 Sep 6.

    PMID: 28877894DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva

Study Officials

  • Elizabeth B Klerman, MD PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 27, 2016

Study Start

September 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

US(1)