Increasing Childhood Sleep Duration in the Primary Care Setting

NCT ID: NCT03870282

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2021-01-03

Brief Summary

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

Detailed Description

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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).

Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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9h 15m Goal

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive B | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive B | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive B | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A&B | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentive A&B | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

9h 15m Goal | Incentives A&B | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive B | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive B | Text A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive B | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A&B | Texts B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentive A&B | Texts A

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Personal Goal | Incentives A&B | Texts A&B

Group Type EXPERIMENTAL

Sleep Extension

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan A Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Childern's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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18-015830

Identifier Type: -

Identifier Source: org_study_id

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