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Completed

NCT Number: NCT03426644

Mobile Health Sleep and Growth Study 2

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

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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Sleep and Growth Study

Behavioral

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 outcomes

  1. Time In bed

    Time frame: 7 Weeks

    Time in bed is measured by a FitBit

Secondary outcomes

  1. Total Sleep Time

    Time frame: 7 Weeks

    Total Sleep Time is measured by a FitBit

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Normative Feedback and Framing Incentives to Encourage Sleep Extension in Children

Acronym: mSGrow2

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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