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Mobile Health Sleep and Growth Study 2 (mSGrow2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426644
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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

Condition or disease Intervention/treatment Phase
Childhood Sleep Promotion Behavioral: Mobile Sleep and Growth Study Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Normative Feedback and Framing Incentives to Encourage Sleep Extension in Children
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018

Arm Intervention/treatment
Active Comparator: Group A
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
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.

Experimental: Group B
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
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.

Experimental: Group C
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
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.

Experimental: Group D
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
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.




Primary Outcome Measures :
  1. Time In bed [ Time Frame: 7 Weeks ]
    Time in bed is measured by a FitBit


Secondary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 7 Weeks ]
    Total Sleep Time is measured by a FitBit



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females age 10 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 smart phone with a data and text plan.
  5. 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:

  1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
  2. Syndromic obesity.
  3. Diagnosed with a psychiatric disorder [(e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety)].
  4. Diagnosed with an eating disorder.
  5. Musculoskeletal or neurological disorder that limits physical movement and activity.
  6. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426644


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jonathan Mitchell, Ph.D. Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03426644    
Other Study ID Numbers: 17-014700
K01HL123612 ( U.S. NIH Grant/Contract )
UL1TR001878 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Childhood sleep promotion
Sleep promotion
Sleep