Mobile Health Sleep and Growth Study 2

Study Overview
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Brief Summary
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Investigators seek to determine if an online behavioral economic based intervention can be developed to target increases in childhood time in bed (TIB).

Detailed Description
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Investigators seek to determine if an online behavioral economic based intervention can be developed to target increases in childhood time in bed (TIB). The primary objectives of this study are to determine if the behavioral economic strategy of compensatory effect leads to the middle time in bed (TIB) target to be most commonly selected, and if the behavioral economic strategies of normative feedback and loss-framed incentives lead to longer TIB and therefore longer total sleep time.Children aged 10-12 who sleep about 7-8 hours per night will wear a FitBit for 11 weeks in order to measure time in bed and total sleep time. Participants will have a time in bed goal to meet each night. Participants will be randomized to one of four study arms and receive text and/or email messaging from the study about sleep hygiene. Some study arms receive additional messaging. The study involves two visits to the Children's Hospital of Philadelphia (CHOP) Roberts Center for Pediatric Research.

Official Title
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Normative Feedback and Framing Incentives to Encourage Sleep Extension in Children

Conditions
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Childhood Sleep Promotion

Intervention / Treatment
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* Behavioral: Mobile Sleep and Growth Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 10 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 smart phone with a data and text plan. Parent reported time in bed on school nights between 7-8 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). Syndromic obesity. 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
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>A time in bed target will be assigned to participants and parents will receive sleep tips by text messages to help reach the selected target. | Behavioral: Mobile Sleep and Growth Study<br>* The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.<br>|
| Experimental: Group B<br>A time in bed target will be assigned to participants and parents will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group B. | Behavioral: Mobile Sleep and Growth Study<br>* The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.<br>|
| Experimental: Group C<br>A time in bed target will be assigned to participants and parents will receive sleep tips by text messages to help reach the selected target.In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group C. | Behavioral: Mobile Sleep and Growth Study<br>* The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.<br>|
| Experimental: Group D<br>A time in bed target will be assigned to participants and parents will receive sleep tips by text messages to help reach the selected target. In addition, participants in this study arm will receive additional motivational text messages beyond those given to Group A, and unique to Group D. | Behavioral: Mobile Sleep and Growth Study<br>* The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time In bed | Time in bed is measured by a FitBit | 7 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | Total Sleep Time is measured by a FitBit | 7 Weeks | 

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