NCT03964181

Brief Summary

Sleep is not an optional luxury, but a fundamental biological need, essential for health and well-being. Insufficient sleep is a significant public health issue, with 69% of adolescents in America obtaining less than the minimum requirement of 8 hours of sleep per night. Early school start times has been identified as the most significant and modifiable factor that restricts sleep duration in adolescents. The American Academy of Pediatrics recommended in 2014 that all middle and high schools start no earlier than 8:30 a.m., yet few school districts have implemented this change. In fall 2017, the Cherry Creek School District, a diverse district of almost 55,000 students outside Denver, changed school start times. Although previous studies have shown increased sleep duration, decreased daytime sleepiness, and improved academics following start time changes for secondary students, there remains an urgent need to understand how this policy impacts health and well-being for all students, including youth in elementary school. Recognizing that students are part of a complex system that includes parents, school staff, and the community, this observational study will be a multi-year, broad-based evaluation that includes key stakeholders, multiple sources of quantitative data (i.e., surveys, academic records, district nursing electronic health records), contextual qualitative data (i.e., open-ended surveys and focus groups), and community-based outcomes (i.e., data on vehicle crashes and juvenile crimes). The primary hypothesis is that later school start times will have a positive impact on middle and high school students sleep and health outcomes, while earlier school start times will have a neutral impact on elementary school students sleep and health outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

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

April 11, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

May 22, 2019

Last Update Submit

September 27, 2022

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • Change in sleep duration from before start time change to 1 and 2 years after start time change

    Reported sleep from bedtime to wake time

    Typical bedtime and wake time, assessed prior to start time change, and 1 and 2 years after start time change

Study Arms (3)

Students Grades 3-12

Other: Change in school start times

Parents of Students Grades K-12

Other: Change in school start times

School Based Teachers and Staff Grades K-12

Other: Change in school start times

Interventions

Change in school start timesOTHER

Elementary start times changed from 9:00 a.m. to 8:00 a.m.; middle school start times changed from 8:00 a.m. to 8:50 a.m.; high school start times changed from 7:10 a.m. to 8:20 a.m.

Parents of Students Grades K-12School Based Teachers and Staff Grades K-12Students Grades 3-12

Eligibility Criteria

Age8 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were drawn from the Cherry Creek School District outside of Denver, Colorado

You may qualify if:

  • Students in grades 3-12 enrolled in the school district
  • Parents of students in grades K-12 enrolled in the school district
  • School-based teachers and staff in grades K-12 in the school district

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Related Publications (4)

  • Meltzer LJ, McNally J, Plog AE, Siegfried SA. Engaging the community in the process of changing school start times: experience of the Cherry Creek School District. Sleep Health. 2017 Dec;3(6):472-478. doi: 10.1016/j.sleh.2017.08.005. Epub 2017 Oct 16.

    PMID: 29157642RESULT

  • Meltzer LJ, Wahlstrom KL, Plog AE, Strand MJ. Changing school start times: impact on sleep in primary and secondary school students. Sleep. 2021 Jul 9;44(7):zsab048. doi: 10.1093/sleep/zsab048.

    PMID: 33855446RESULT

  • Meltzer LJ, Wahlstrom KL, Plog AE, McNally J. Impact of changing school start times on parent sleep. Sleep Health. 2022 Feb;8(1):130-134. doi: 10.1016/j.sleh.2021.08.003. Epub 2021 Oct 9.

    PMID: 34642123RESULT

  • Meltzer LJ, Plog AE, Wahlstrom KL, Strand MJ. Biology vs. ecology: a longitudinal examination of sleep, development, and a change in school start times. Sleep Med. 2022 Feb;90:176-184. doi: 10.1016/j.sleep.2022.01.003. Epub 2022 Jan 10.

    PMID: 35182977RESULT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 28, 2019

Study Start

April 11, 2017

Primary Completion

May 31, 2019

Study Completion

July 31, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations

US(1)