Outcomes {12}
sleepiness, sleep disturbance, sleep-related impairment
SECONDARY
Study outcomes and assessment time points are listed in Fig. Primary outcome: The primary outcome is a change in sleep duration from baseline to 8 weeks. Sleep duration at baseline and 8 weeks will each be calculated as averages over 10-day periods. Sleep duration will be measured by 8–10 days of actigraphy at baseline/screening, week 8, and 6 and 12 months with the Actiwatch Spectrum device (Philips Respironics Inc.). Devices will be configured using default settings and scored using the Acitware Software (Philips Respironics, Inc.). Actigraphy will be manually scored using a standardized procedure [Main secondary outcome: The main secondary outcome will be change in 24-h SBP from baseline to 8 weeks. This measure will be calculated as an average for the 24-h period at baseline and 8 weeks. BP will be assessed by 24-h ABPM at home using the Spacelabs ambulatory BP monitor (Spacelabs Healthcare, Hertford, UK). Participants will wear the BP monitor at baseline/screening, week 8, and 6 and 12 months. Monitors will be programmed to take readings in random 20-min intervals during the day and 30-min intervals at night.Other secondary outcomes: Changes from baseline to 6 months and from baseline to 12 months will be measured to evaluate the maintenance of sleep duration changes. In addition, changes in 24-h SBP from baseline to 6 and 12 months will be measured to evaluate the maintenance. We will also measure the change in 24-h diastolic blood pressure (DBP) from baseline to 8 weeks and 6 and 12 months. We will measure diet quality by administering the Automated Self-Administered 24-h Dietary Assessment Tool and calculating the Healthy Eating Index (HEI-2018) [Objective 24-h physical activity data including sedentary behavior will be collected using the ActivPAL4 activity monitor [Other measures of cardiometabolic risk will be measured at screening, week 8, and months 6 and 12 including BMI and body fat estimation using a bioimpedance scale (Tanita of America), waist and hip circumference, lipids, and HbA1c. We will also evaluate the effects on nocturnal and diurnal BP and on non-dipping BP status defined by ABPM levels as mean nighttime to daytime SBP/DBP ratio of > 0.90.Participants will complete measures of patient-reported outcomes at session baseline, week 8, and months 3, 6, 9, and 12, including the PROMIS sleep disturbance, sleep-related impairment and sleepiness [We will assess the intervention acceptability and user engagement to inform our findings and plan for future studies (Fitbit usage, coaching session attendance and duration, and email lesson engagement and use surveys and open-ended questions at the end of the intervention and follow-up periods).