Increasing Childhood Sleep Duration in the Primary Care Setting
1 other identifier
interventional
97
1 country
1
Brief Summary
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.
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 Feb 2019
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
February 21, 2019
CompletedFirst Submitted
Initial submission to the registry
March 8, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2021
CompletedMarch 24, 2021
March 1, 2021
1.7 years
March 8, 2019
March 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actigraphy Estimated Weeknight Sleep Duration
The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.
10 weeks
Secondary Outcomes (2)
Sleep Disturbance Score
15 minutes
Sleep Related Impairment Score
15 minutes
Other Outcomes (3)
Actigraphy Estimated Nighttime Sleep Duration
10 weeks
Actigraphy Estimated Weekend Night Sleep Duration
10 weeks
Actigraphy Estimated Sleep Efficiency (Nighttime, Weeknight and Weekend Night)
10 weeks
Study Arms (32)
9h 15m Goal
EXPERIMENTAL9h 15m Goal | Texts B
EXPERIMENTAL9h 15m Goal | Texts A
EXPERIMENTAL9h 15m Goal | Texts A&B
EXPERIMENTAL9h 15m Goal | Incentive B
EXPERIMENTAL9h 15m Goal | Incentive B | Texts B
EXPERIMENTAL9h 15m Goal | Incentive B | Texts A
EXPERIMENTAL9h 15m Goal | Incentive B | Texts A&B
EXPERIMENTAL9h 15m Goal | Incentive A
EXPERIMENTAL9h 15m Goal | Incentive A | Texts B
EXPERIMENTAL9h 15m Goal | Incentive A | Texts A
EXPERIMENTAL9h 15m Goal | Incentive A | Texts A&B
EXPERIMENTAL9h 15m Goal | Incentive A&B
EXPERIMENTAL9h 15m Goal | Incentive A&B | Texts B
EXPERIMENTAL9h 15m Goal | Incentive A&B | Texts A
EXPERIMENTAL9h 15m Goal | Incentives A&B | Texts A&B
EXPERIMENTALPersonal Goal
EXPERIMENTALPersonal Goal | Texts B
EXPERIMENTALPersonal Goal | Texts A
EXPERIMENTALPersonal Goal | Texts A&B
EXPERIMENTALPersonal Goal | Incentive B
EXPERIMENTALPersonal Goal | Incentive B | Texts B
EXPERIMENTALPersonal Goal | Incentive B | Text A
EXPERIMENTALPersonal Goal | Incentive B | Texts A&B
EXPERIMENTALPersonal Goal | Incentive A
EXPERIMENTALPersonal Goal | Incentive A | Texts B
EXPERIMENTALPersonal Goal | Incentive A | Texts A
EXPERIMENTALPersonal Goal | Incentive A | Texts A&B
EXPERIMENTALPersonal Goal | Incentive A&B
EXPERIMENTALPersonal Goal | Incentive A&B | Texts B
EXPERIMENTALPersonal Goal | Incentive A&B | Texts A
EXPERIMENTALPersonal Goal | Incentives A&B | Texts A&B
EXPERIMENTALInterventions
The intervention is designed to test if sleep tips delivered by text messages can aid with reaching sleep targets. And if additional motivational text messages can further aide with reaching sleep targets.
Eligibility Criteria
You may qualify if:
- Males or females age 9 to 12 years.
- Speak, read and write in English.
- Parental/guardian permission (informed consent) and child assent.
- Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm \& get out of bed at 6am).
You may not qualify if:
- Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- Diagnosed with a psychiatric disorder \[e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety\].
- Diagnosed with an eating disorder.
- Musculoskeletal or neurological disorder that limits physical movement and activity.
- Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan A Mitchell, PhD
Childern's Hospital of Philadelphia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2019
First Posted
March 12, 2019
Study Start
February 21, 2019
Primary Completion
November 1, 2020
Study Completion
January 3, 2021
Last Updated
March 24, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share