Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorChildren's Hospital of Philadelphia
About this trial
The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 8-12 years olds.
Insufficient sleep duration (<8.5 hours per night).
Body mass index (BMI) between the 50th and 95th percentile for age and sex.
One child per family.
Disqualifiers
Diagnosed with a chronic disease.
Diagnosed with a behavioral health problem.
Diagnosed with a condition that can impact sleep or growth.
Diagnosed with a condition affecting physical growth and maturation or dietary intake.
Trial design
Design model
Factorial
Treatments tested in this trial
Fixed sleep goal
BehavioralInvestigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.
Personalized sleep goal
BehavioralInvestigators will determine if a personalized goal (≥9 hours per night, but can be lowered to a personalized level, capped at +30 minutes per night above baseline) is more efficacious for increasing sleep duration.
Digital sleep health messaging without virtual study visit
BehavioralAll participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. This group will NOT have virtual psychological visits.
Digital sleep health messaging with virtual study visit
BehavioralAll participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. The participants will be randomized to additionally receive virtual study visits where doctoral-level psychology trainees will be trained to implement evidence-based behavioral sleep health guidance.
Inactive Parent-Directed Loss-Framed Incentive
BehavioralNo parental incentive
Active Parent-Directed Loss-Framed Incentive
BehavioralParents will receive a financial incentive when their child achieves their sleep goal. The incentive will be loss-framed; parents will receive an endowment of $10 at the start of each intervention week, in a virtual bank account; Investigators will deduct $2 each weeknight the sleep duration goal is not met; the funds remaining in the virtual account will be dispensed each Sunday. The weekly endowment-payment approach allows for fresh starts each week. The incentive will be directed at parents as a method to enhance engagement. Investigators will ask parents at baseline and at the end of each month to rate their perceived support in helping their child to meet their sleep duration goal.
Inactive Supportive Feedback
BehavioralNo supportive feedback
Active Supportive Feedback
BehavioralParticipants will receive a weekly performance summary message each Sunday during the intervention period, with supportive feedback included to motivate children to maintain their good performance in the week ahead, or to try and improve upon a weak or moderate performance in the week ahead. Investigators will ask children will complete an online survey each Sunday to measure how motivated they are to achieve their sleep goal in the week ahead.
Treatment groups
5,000 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Condition 1Active comparator 4 interventions
Group B: Condition 2Active comparator 4 interventions
Group C: Condition 3Active comparator 4 interventions
Group D: Condition 4Active comparator 4 interventions
Group E: Condition 5Active comparator 4 interventions
Group F: Condition 6Active comparator 4 interventions
Group G: Condition 7Active comparator 4 interventions
Group H: Condition 8Active comparator 4 interventions
Group I: Condition 9Active comparator 4 interventions
Group J: Condition 10Active comparator 4 interventions
Group K: Condition 11Active comparator 4 interventions
Group L: Condition 12Active comparator 4 interventions
Group M: Condition 13Active comparator 4 interventions
Group N: Condition 14Active comparator 4 interventions
Group O: Condition 15Active comparator 4 interventions
Group P: Condition 16Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in sleep duration
The primary outcome for aims 1 and 3 is change in nighttime sleep duration (hours per night) on weeknights measured by a sleep tracker with high sensitivity and moderate specificity for measuring sleep.
Time frame
baseline to 12 months2
Change in fat mass index Z-score
Aim 2 primary outcome. Total body fat mass will be measured by DXA. Fat mass index (FMI, kg of fat divided by height in meters squared) will be calculated, and age and gender specific FMI Z-scores will be determined using U.S. specific FMI growth charts.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Change in sleep onset
Change in sleep onset (time subject falls asleep). Weeknights and weekends will be measured separately.
Time frame
Baseline to 12 months2
Change in sleep offset
Change in sleep offset (time subject wakes up). Weeknights and weekends will be measured separately.
Time frame
Baseline to 12 months3
Change in sleep midpoint
Change in sleep midpoint. Weeknights and weekends will be measured separately.
Time frame
Baseline to 12 months4
Change in social jetlag
Investigators will calculate "social jetlag" by subtracting the weekend night sleep midpoint from the weeknight sleep midpoint. Social jetlag provides an indication of the discrepancy between internal biological clocks and social requirements and has been linked to cardiometabolic risk.
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Philadelphia
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov