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OpenTrials
Completed

NCT Number: NCT03870282

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.

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Key information

Conditions

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Extension

Behavioral

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.

Primary outcomes

  1. 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

  1. Sleep Disturbance Score

    Time frame: 15 minutes

    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.

  2. Sleep Related Impairment Score

    Time frame: 15 minutes

    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.

Other outcomes

  1. Actigraphy Estimated Nighttime Sleep Duration

    Time frame: 10 weeks

    The investigators' other outcomes are actigraphy estimated nighttime sleep duration operationalized as the average hours per night per week.

  2. Actigraphy Estimated Weekend Night Sleep Duration

    Time frame: 10 weeks

    The investigators' other outcomes are actigraphy estimated weekend night sleep duration operationalized as the average hours per weekend night per week.

  3. Actigraphy Estimated Sleep Efficiency (Nighttime, Weeknight and Weekend Night)

    Time frame: 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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