Mobile Health Sleep and Growth Study 2

Not Applicable

Completed

• Conditions: Childhood Sleep Promotion

• Registration Number: NCT03426644
• Lead Sponsor: 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).

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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-08
• Study Start: 2018-02-26
• Primary Completion: 2018-12-17
• Study Completion: 2018-12-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time In bed	7 Weeks	Time in bed is measured by a FitBit

Secondary Outcome Measures

Name	Time	Method
Total Sleep Time	7 Weeks	Total Sleep Time is measured by a FitBit

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States