Increasing Childhood Sleep Duration in the Primary Care Setting

Study 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).

Official Title
-----------------
Increasing Childhood Sleep Duration in the Primary Care Setting

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: Sleep Extension


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood sleep promotion, Sleep promotion, Sleep