Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Young Adult Cancer Survivors: Design and Methods of Opt2Move Full Factorial Trial.

Background: Opt2Move is a theory-guided moderate and vigorous physical activity (MVPA) promotion trial that uses multiphase optimization strategy (MOST) methodology to evaluate the individual and combined effects of four intervention components in a full factorial experiment among young adult cancer survivors (YACS; N = 304). All participants will receive the core mHealth MVPA intervention, which includes a Fitbit and standard self-monitoring Opt2Move smartphone application. YACS will be randomized to one of 16 conditions to receive between zero and four additional components each with two levels (yes v. no): E-Coach, buddy, general mindfulness, and MVPA-specific mindfulness. Objective: The primary aim is to determine the individual and combined effects of the components on MVPA post-intervention (12-weeks) and at 24-week follow-up. The secondary aim is to examine how changes in MVPA are associated with patient-reported outcomes, light-intensity activity, sedentary time, and sleep duration and quality. Potential mediators and moderators of component effects will also be examined. Results: Results will support the selection of a package of intervention components optimized to maximize MVPA to be tested in a randomized controlled trial. Conclusion: Opt2Move represents the first systematic effort to use MOST to design an optimized, scalable mHealth MVPA intervention for YACS and will lead to an improved understanding of how to effectively change YACS' MVPA and ultimately, improve health and disease outcomes.

Feasibility and preliminary effects of the Fit2ThriveMB pilot physical activity promotion intervention on physical activity and patient reported outcomes in individuals with metastatic breast cancer.

PURPOSE: Physical activity research among patients with metastatic breast cancer (MBC) is limited. This study examined the feasibility and potential benefits of Fit2ThriveMB, a tailored mHealth intervention. METHODS: Insufficiently active individuals with MBC (n = 49) were randomized 1:1 to Fit2ThriveMB (Fit2ThriveMB app, Fitbit, and weekly coaching calls) or Healthy Lifestyle attention control (Cancer.Net app and weekly calls) for 12 weeks. Fit2ThriveMB aimed to increase daily steps via an algorithm tailored to daily symptom rating and step goal attainment. The primary outcome was feasibility defined as ≥ 80% completion rate. Secondary feasibility metrics included meeting daily step goal and wearing the Fitbit ≥ 70% of study days, fidelity, adherence to intervention features and safety. Secondary outcomes included physical activity, sedentary time, patient reported outcomes (PROs), health-related quality of life (QOL) and social cognitive theory constructs. A subsample (n = 25) completed functional performance tests via video conferencing. RESULTS: The completion rate was 98% (n = 1 died). No related adverse events were reported. Fit2ThriveMB participants (n = 24) wore the Fitbit 92.7%, met their step goal 53.1%, set a step goal 84.6% and used the app 94.1% of 84 study days. Intent-to-treat analyses indicated trends toward improvements in activity, QOL, and some PROs, social cognitive theory constructs, and functional performance tests favoring the Fit2ThriveMB group. Significant effects favoring Fit2ThriveMB were observed for self-efficacy and goal-setting. However, some PROs and functional performance improvements favored the control group (p-values > 0.05). CONCLUSIONS: Fit2ThriveMB is feasible and safe for patients with MBC and warrants further evaluation in randomized controlled trials with larger sample sizes. Registration Clinicaltrials.gov NCT04129346, https://clinicaltrials.gov/ct2/show/NCT04129346.

StandUPTV: Preparation and optimization phases of a mHealth intervention to reduce sedentary screen time in adults.

Recreational sedentary screen time (rSST) is the most prevalent sedentary behavior for adults outside of work, school, and sleep, and is strongly linked to poor health. StandUPTV is a mHealth trial that uses the Multiphase Optimization Strategy (MOST) framework to develop and evaluate the efficacy of three theory-based strategies for reducing rSST among adults. This paper describes the preparation and optimization phases of StandUPTV within the MOST framework. We identified three candidate components based on previous literature: (a) rSST electronic lockout (LOCKOUT), which restricts rSST through electronic means; (b) adaptive prompts (TEXT), which provides adaptive prompts based on rSST behaviors; and (c) earning rSST through increased moderate-vigorous physical activity (MVPA) participation (EARN). We also describe the mHealth iterative design process and the selection of an optimization objective. Finally, we describe the protocol of the optimization randomized controlled trial using a 23 factorial experimental design. We will enroll 240 individuals aged 23-64 y who engage in >3 h/day of rSST. All participants will receive a target to reduce rSST by 50% and be randomized to one of 8 combinations representing all components and component levels: LOCKOUT (yes vs. no), TEXT (yes vs. no), and EARN (yes vs. no). Results will support the selection of the components for the intervention package that meet the optimization objective and are acceptable to participants. The optimized intervention will be tested in a future evaluation randomized trial to examine reductions in rSST on health outcomes among adults.

SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial.

OBJECTIVE: To investigate the feasibility and acceptability of SleepWell24, a multicomponent, evidence-based smartphone application, to improve positive airway pressure therapy (PAP) adherence, among patients with obstructive sleep apnea (OSA) naive to PAP. METHODS: In a single-blind randomized controlled trial, SleepWell24, with a companion activity monitor was compared to usual care plus the activity monitor and its associated app. SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes. RESULTS: Of 103 eligible participants, 87 were enrolled (SleepWell24 n = 40, control n = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. SleepWell24 participants engaged with the app on 62.9% of trial days. PAP use was high across both arms (SleepWell24 vs. Control: mean hours 5.98 vs. 5.86). There were no differences in PAP adherence or clinical outcomes. CONCLUSIONS: SleepWell24 was feasible and acceptable among PAP-naive patients with OSA. CLINICAL TRIAL REGISTRATION: NCT03156283https://www.clinicaltrials.gov/study/NCT03156283.

Effects of Increased Standing and Light-Intensity Physical Activity to Improve Postprandial Glucose in Sedentary Office Workers: Protocol for a Randomized Crossover Trial.

BACKGROUND: Prolonged bouts of sedentary time, independent from the time spent in engaging in physical activity, significantly increases cardiometabolic risk. Nonetheless, the modern workforce spends large, uninterrupted portions of the day seated at a desk. Previous research suggests-via improved cardiometabolic biomarkers-that this risk might be attenuated by simply disrupting sedentary time with brief breaks of standing or moving. However, this evidence is derived from acute, highly controlled laboratory experiments and thus has low external validity. OBJECTIVE: This study aims to investigate if similar or prolonged cardiometabolic changes are observed after a prolonged (2-week) practice of increased brief standing and moving behaviors in real-world office settings. METHODS: This randomized crossover trial, called the WorkWell Study, will compare the efficacy of two 2-week pilot intervention conditions designed to interrupt sitting time in sedentary office workers (N=15) to a control condition. The intervention conditions use a novel smartphone app to deliver real-time prompts to increase standing (STAND) or moving (MOVE) by an additional 6 minutes each hour during work. Our primary aim is to assess intervention-associated improvements to daily postprandial glucose using continuous glucose monitors. Our secondary aim is to determine whether the interventions successfully evoke substantive positional changes and light-intensity physical activity (LPA). Other outcomes include the feasibility and acceptability of the intervention conditions, fasting blood glucose concentration, femoral artery flow-mediated dilation (f-FMD), and systolic and diastolic blood pressure. RESULTS: The trial is ongoing at the time of submission. CONCLUSIONS: This study is a novel, randomized crossover trial designed to extend a laboratory-based controlled study design into the free-living environment. By using digital health technologies to monitor and prompt participants in real time, we will be able to rigorously test the effects of breaking up sedentary behavior over a longer period of time than is seen in traditional laboratory-based studies. Our innovative approach will leverage the strengths of highly controlled laboratory and free-living experiments to achieve maximal internal and external validity. The research team's multidisciplinary expertise allows for a broad range of biological measures to be sampled, providing robust results that will extend knowledge of both the acute and chronic real-life effects of increased standing and LPA in sedentary office workers. The WorkWell Study uses a rigorous transdisciplinary protocol that will contribute to a more comprehensive picture of the beneficial effects of breaking up sitting behavior. TRIAL REGISTRATION: ClinicalTrials.gov NCT04269070; https://clinicaltrials.gov/study/NCT04269070. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45133.

Role of Data Augmentation Strategies in Knowledge Distillation for Wearable Sensor Data.

Deep neural networks are parametrized by several thousands or millions of parameters, and have shown tremendous success in many classification problems. However, the large number of parameters makes it difficult to integrate these models into edge devices such as smartphones and wearable devices. To address this problem, knowledge distillation (KD) has been widely employed, that uses a pre-trained high capacity network to train a much smaller network, suitable for edge devices. In this paper, for the first time, we study the applicability and challenges of using KD for time-series data for wearable devices. Successful application of KD requires specific choices of data augmentation methods during training. However, it is not yet known if there exists a coherent strategy for choosing an augmentation approach during KD. In this paper, we report the results of a detailed study that compares and contrasts various common choices and some hybrid data augmentation strategies in KD based human activity analysis. Research in this area is often limited as there are not many comprehensive databases available in the public domain from wearable devices. Our study considers databases from small scale publicly available to one derived from a large scale interventional study into human activity and sedentary behavior. We find that the choice of data augmentation techniques during KD have a variable level of impact on end performance, and find that the optimal network choice as well as data augmentation strategies are specific to a dataset at hand. However, we also conclude with a general set of recommendations that can provide a strong baseline performance across databases.

Comparison of Wrist- and Hip-Worn Activity Monitors When Meeting Step Guidelines.

INTRODUCTION: Physical activity (PA) guidelines aimed at accumulating 10,000 steps per day have become increasingly common with the advent of wristband PA monitors. However, accumulated steps measured with wristband PA monitors may not be equal to steps measured with validated, hip-worn pedometers. Consequently, evaluating and developing guidelines for step counts using wristband PA monitors for the general population is needed. We compared step counts accumulated with hip-worn pedometers with those accumulated with wrist-worn activity monitors during 1) treadmill exercise, 2) treadmill walking, and 3) activities of daily living (ADL) to determine their accuracy in meeting step count guidelines (ie, 10,000 steps/d). METHODS: Eighty-six adults (aged 18-65 y; body mass index, 19-45 kg/m2) completed 30 minutes of treadmill exercise while simultaneously using a hip-worn pedometer and wrist-worn PA monitor. Remaining steps needed to reach 10,000 steps (ie, 10,000 steps minus the number of pedometer steps recorded from treadmill exercise = remainder) were completed via treadmill walking or ADL. Steps were recorded for both devices after treadmill exercise, treadmill walking, and ADL for both devices. RESULTS: Fewer steps were accumulated via wrist-worn PA monitors than via hip-worn pedometers during treadmill exercise (3,552 [SD, 63] steps vs 3,790 [SD, 55] steps, P < .01) and treadmill walking (5,877 [SD, 83] steps vs 6,243 [SD, 49] steps, P < .01). More steps were accumulated via wrist-worn PA monitors than hip-worn pedometers during ADL (7,695 [SD, 207] steps vs 6,309 [SD, 57] steps, P < .01). Consequently, total steps were significantly higher for wristband PA monitors than hip-worn pedometers (11,247 [SD, 210] steps vs 10,099 [SD, 39] steps; P < .01). CONCLUSION: The widely used 10,000-step recommendation may not be accurate for all users of all activity monitors, given the discrepancy in daily step count among wrist-worn and hip-worn devices. Having a more accurate indication of number of steps taken per day based on the device used could have positive effects on health.

Impact of the COVID-19 pandemic on change in sleep patterns in an exploratory, cross-sectional online sample of 79 countries.

OBJECTIVES: To describe changes in sleep patterns during the coronavirus disease 2019 (COVID-19) pandemic, develop profiles according to these patterns, and assess sociodemographic, economic, COVID-19 related, and sleep and mental health factors associated with these profiles. DESIGN, SETTING, AND PARTICIPANTS: A 25-minute online survey was distributed worldwide through social media from 5/21/2020 to 7/1/2020. MEASUREMENTS: Participants reported sociodemographic/economic information, the impact of the pandemic on major life domains, insomnia and depressive symptoms, and changes in sleep midpoint, time-in-bed, total sleep time (TST), sleep efficiency (SE), and nightmare and nap frequency from prior to during the pandemic. Sleep pattern changes were subjected to latent profile analysis. The identified profiles were compared to one another on all aforementioned factors using probit regression analyses. RESULTS: The sample of 991 participants (ages: 18-80 years; 72.5% women; 60.3% residing outside of the United States) reported significantly delayed sleep midpoint, reductions in TST and SE, and increases in nightmares and naps. Over half reported significant insomnia symptoms, and almost two-thirds reported significant depressive symptoms. Latent profile analysis revealed 4 sleep pattern change profiles that were significantly differentiated by pre-pandemic sleep patterns, gender, and various COVID-19-related impacts on daily living such as severity of change in routines, and family stress and discord. CONCLUSIONS: In an international online sample, poor sleep and depressive symptoms were widespread, and negative shifts in sleep patterns from pre-pandemic patterns were common. Differences in sleep pattern response to the COVID-19 crisis suggest potential and early targets for behavioral sleep health interventions.

Efficacy of the 'Stand and Move at Work' multicomponent workplace intervention to reduce sedentary time and improve cardiometabolic risk: a group randomized clinical trial.

BACKGROUND: Sedentary time is associated with chronic disease and premature mortality. We tested a multilevel workplace intervention with and without sit-stand workstations to reduce sedentary time and lower cardiometabolic risk. METHODS: Stand and Move at Work was a group (cluster) randomized trial conducted between January 2016 and December 2017 among full-time employees; ≥18 years; and in academic, industry/healthcare, and government worksites in Phoenix, Arizona and Minneapolis/St. Paul, Minnesota, USA. Eligible worksites were randomized to (a) MOVE+, a multilevel intervention targeting reduction in sedentary time and increases in light physical activity (LPA); or (b) STAND+, the MOVE+ intervention along with sit-stand workstations to allow employees to sit or stand while working. The primary endpoints were objectively-measured workplace sitting and LPA at 12 months. The secondary endpoint was a clustered cardiometabolic risk score (blood pressure, glucose, insulin, triglycerides, and HDL-cholesterol) at 12 months. RESULTS: Worksites (N = 24; academic [n = 8], industry/healthcare [n = 8], and government [n = 8] sectors) and employees (N = 630; 27 ± 8 per worksite; 45 ± 11 years of age, 74% female) were enrolled. All worksites were retained and 487 participants completed the intervention and provided data for the primary endpoint. The adjusted between arm difference in sitting at 12 months was - 59.2 (CI: - 74.6,-43.8) min per 8 h workday, favoring STAND+, and in LPA at 12 months was + 2.2 (- 0.9,5.4) min per 8 h workday. Change in the clustered metabolic risk score was small and not statistically significant, but favored STAND+. In an exploratory subgroup of 95 participants with prediabetes or diabetes, the effect sizes were larger and clinically meaningful, all favoring STAND+, including blood glucose, triglycerides, systolic blood pressure, glycated hemoglobin, LDL-cholesterol, body weight, and body fat. CONCLUSIONS: Multilevel workplace interventions that include the use of sit-stand workstations are effective for large reductions in sitting time over 12 months. Among those with prediabetes or diabetes, clinical improvements in cardiometabolic risk factors and body weight may be realized. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02566317 . Registered 2 October 2015, first participant enrolled 11 January 2016.

Rationale, design, and development of SleepWell24: A smartphone application to promote adherence to positive airway pressure therapy among patients with obstructive sleep apnea.

BACKGROUND: Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability. METHODS/DESIGN: To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA. DISCUSSION: SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes.