Mobile Sleep and Growth Study

Study Overview
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Brief Summary
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The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor.

Official Title
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Mobile Health Sleep and Growth Study

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 smartphone with a data and text plan. Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm & 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>Participants will select a time in bed target and 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>Participants will select a time in bed target and 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>Participants will select a time in bed target and 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>|

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 estimated using a Fitbit activity tracker | 50-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time | Total sleep time is estimated using a Fitbit activity tracker | 50-days |