PROMOTING SLEEP DURATION IN THE PEDIATRIC SETTING USING A MOBILE HEALTH PLATFORM: A RANDOMIZED OPTIMIZATION TRIAL

Objective Determine the optimal combination of digital health intervention component settings that increase average sleep duration by ≥30 minutes per weeknight. Methods Optimization trial using a 2[5][1] factorial design. The trial included 2 week run-in, 7 week intervention, and 2 week follow-up periods. Typically developing children aged 9-12y, with weeknight sleep duration <8.5 hours were enrolled (N=97). All received sleep monitoring and performance feedback. The five candidate intervention components ( with their settings to which participants were randomized ) were: 1) sleep goal ( guideline-based or personalized ); 2) screen time reduction messaging ( inactive or active ); 3) daily routine establishing messaging ( inactive or active ); 4) child-directed loss-framed financial incentive ( inactive or active ); and 5) caregiver-directed loss-framed financial incentive ( inactive or active ). The primary outcome was weeknight sleep duration (hours per night). The optimization criterion was: ≥30 minutes average increase in sleep duration on weeknights. Results Average baseline sleep duration was 7.7 hours per night. The highest ranked combination included the core intervention plus the following intervention components: sleep goal (either setting was effective), caregiver-directed loss-framed incentive, messaging to reduce screen time, and messaging to establish daily routines. This combination increased weeknight sleep duration by an average of 39.6 (95% CI: 36.0, 43.1) minutes during the intervention period and by 33.2 (95% CI: 28.9, 37.4) minutes during the follow-up period. Conclusions Optimal combinations of digital health intervention component settings were identified that effectively increased weeknight sleep duration. This could be a valuable remote patient monitoring approach to treat insufficient sleep in the pediatric setting. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT03870282 ### Funding Statement The study was supported by an NIH/NHLBI Career Development Award K01HL123612 (PI Dr. Mitchell, Children Hospital of Philadelphia Possibilities Project Funds and Academic Enrichment Funds (PI: Dr. Mitchell) and a Eunice Kennedy Shriver National Institute of Child Health and Human Development Career Development Award K23HD094905 (PI: Dr. Williamson). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Children Hospital of Philadelphia (CHOP) Institutional Review Board approved this study I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: #ref-5