Student Exercise and Sleep Timing Study - Part 2
SiESTa 2
1 other identifier
interventional
62
1 country
6
Brief Summary
The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality. Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration. Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger). Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedStudy Start
First participant enrolled
October 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 16, 2026
November 21, 2024
November 1, 2024
2.1 years
February 29, 2024
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Quality
Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves sleep (quality and duration). Sleep quality includes variables such as the actigraph measured sleep period, total sleep time, sleep efficiency, and wake after sleep onset. Sleep quality and duration will be measured using wrist actigraphy, specifically the Phillips Actiwatch Spectrum Plus devices. The Epworth Sleepiness Scale will also be utilized to measure sleep quality, where scores range from 0-24 and higher scores signify more exhaustion and poorer sleep quality.
2 weeks
Secondary Outcomes (3)
Mood
2 weeks
Stress
2 weeks
Productivity
2 weeks
Study Arms (2)
Normal Exercise
NO INTERVENTIONThis arm has no intervention. Participants will continue to exercise at their normal evening time (6pm-11pm).
Morning Exercise
EXPERIMENTALParticipants will change their exercise times to the morning (6am-11am).
Interventions
Exercise is changed from normal (6pm-11pm) exercise to morning (6am-11am) exercise.
Eligibility Criteria
You may qualify if:
- Healthy undergraduates (18-23 years)
- Frequent evening exercisers (6pm-11pm, 3+ times per week)
- Poor self-reported sleep quality
- Must be willing to wear wrist actigraph 24/7 except when showering/bathing
You may not qualify if:
- Sleep/circadian rhythm disorders
- Medications for sleep
- Inability to change schedule to exercise in AM
- Inability to maintain exercise frequency over next 4 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
College Avenue Gym
New Brunswick, New Jersey, 08901, United States
Cook/Douglass Rec Center
New Brunswick, New Jersey, 08901, United States
Rutgers Fitness Center
New Brunswick, New Jersey, 08901, United States
Rutgers Sleep Lab
New Brunswick, New Jersey, 08901, United States
Livingston Rec Center
Piscataway, New Jersey, 08854, United States
Werblin Rec Center
Piscataway, New Jersey, 08854, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Spaeth, PhD
Rutgers, The State University of New Jersey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary Investigator
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 29, 2024
Study Start
October 21, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 16, 2026
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The deidentified data will be sent to vetted researchers who request it after the data collection period is complete. It will only be available for those vetted researchers for 6 years after the data collection period is complete.
The only IDP sharing that may occur is to other vetted researchers, it will not be made available to all researchers.