Increasing Childhood Sleep Duration in the Primary Care Setting

March 23, 2021 updated by: Children's Hospital of Philadelphia
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
15 minutes
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.
15 minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
10 weeks
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.
10 weeks
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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan A Mitchell, PhD, Childern's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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