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Clinical Trials/NCT03870282
NCT03870282
Completed
Not Applicable

Increasing Childhood Sleep Duration in the Primary Care Setting

Children's Hospital of Philadelphia1 site in 1 country97 target enrollmentFebruary 21, 2019
ConditionsSleep

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep
Sponsor
Children's Hospital of Philadelphia
Enrollment
97
Locations
1
Primary Endpoint
Actigraphy Estimated Weeknight Sleep Duration
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.

Detailed Description

Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).

Registry
clinicaltrials.gov
Start Date
February 21, 2019
End Date
January 3, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Actigraphy Estimated Weeknight Sleep Duration

Time Frame: 10 weeks

The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.

Secondary Outcomes

  • Sleep Disturbance Score(15 minutes)
  • Sleep Related Impairment Score(15 minutes)

Study Sites (1)

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