Increasing Childhood Sleep Duration in the Primary Care Setting

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

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep Extension

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).

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females age 9 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
5. 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:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Diagnosed with a psychiatric disorder [e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety].
3. Diagnosed with an eating disorder.
4. Musculoskeletal or neurological disorder that limits physical movement and activity.
5. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

32

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9h 15m Goal	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Texts B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Texts A	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive B | Texts B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive B | Texts A	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive B | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A | Texts B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A | Texts A	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A&B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A&B | Texts B	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentive A&B | Texts A	Behavioral: Sleep Extension; 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.
Experimental: 9h 15m Goal | Incentives A&B | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Texts B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Texts A	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive B | Texts B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive B | Text A	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive B | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A | Texts B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A | Texts A	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A | Texts A&B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A&B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A&B | Texts B	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentive A&B | Texts A	Behavioral: Sleep Extension; 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.
Experimental: Personal Goal | Incentives A&B | Texts A&B	Behavioral: Sleep Extension; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance Score	Measured using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) 9-item bank for pediatric sleep, ages 8-17y. The sleep disturbance score is calculated by summing responses to items related to sleep onset, sleep continuity and sleep quality. Higher scores for sleep disturbance indicate poorer sleep quality. We will operationalize our secondary outcomes as T-scores, using the standard PROMIS approach.	15 minutes
Sleep Related Impairment Score	Measured using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) 9-item bank for pediatric sleep, ages 8-17y. The sleep-related impairment score is calculated by summing responses to items related to daytime sleepiness, cognition, affect & behavior and daytime activities. Higher scores for sleep impairment indicate poorer sleep quality. We will operationalize our secondary outcomes as T-scores, using the standard PROMIS approach.	15 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy Estimated Nighttime Sleep Duration	The investigators' other outcomes are actigraphy estimated nighttime sleep duration operationalized as the average hours per night per week.	10 weeks
Actigraphy Estimated Weekend Night Sleep Duration	The investigators' other outcomes are actigraphy estimated weekend night sleep duration operationalized as the average hours per weekend night per week.	10 weeks
Actigraphy Estimated Sleep Efficiency (Nighttime, Weeknight and Weekend Night)	The investigators' other outcomes are actigraphy estimated sleep efficiency per night, weeknight, and weekend night operationalized as percentage of time spent asleep during the overnight sleep period.	10 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Jonathan A Mitchell, PhD, Childern's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): January 3, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Sleep; Childhood sleep promotion; Sleep promotion
• Other Study ID Numbers: 18-015830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No