Clinical trial NCT03426644: Mobile Health Sleep and Growth Study 2
Official title: Normative Feedback and Framing Incentives to Encourage Sleep Extension in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Sleep Promotion
Keywords: Childhood sleep promotion
Sleep promotion
Sleep
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-02-08
Enrollment: 44
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Time In bed
timeFrame: 7 Weeks
Secondary outcomes:
measure: Total Sleep Time
timeFrame: 7 Weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jonathan Mitchell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.