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.

Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for Cardiometabolic Risk Reduction among African American Women.

This article reports the results of Smart Walk: a randomized pilot trial of an 8-month culturally tailored, smartphone-delivered physical activity (PA) intervention for African American women with obesity. Sixty participants (age range = 24−49 years; BMI range = 30−58 kg/m2) were randomized to the Smart Walk intervention (n = 30) or a wellness comparison intervention (n = 30). Results supported the acceptability and feasibility of the intervention, as demonstrated by participant retention (85% at 4 months and 78% at 8 months), Smart Walk app use, and intervention satisfaction (i.e., 100% of PA participants completing the intervention [n = 24] reported they would recommend it to friend). Smart Walk participants also reported greater increases in moderate-to-vigorous PA (4-month between-arm difference in change [b] = 43.3 min/week; p = 0.018; Cohen's d = 0.69; 8-month b = 56.6 min/week; p = 0.046; d = 0.63) and demonstrated clinically relevant, although not statistically significant (p-values > 0.05), baseline to 4 months improvements in cardiorespiratory fitness (b = 1.67 mL/kg/min; d = 0.40), systolic blood pressure (b = −3.33 mmHg; d = 0.22), diastolic blood pressure (b = −4.28 mmHg; d = 0.37), and pulse wave velocity (b = −0.46 m/s; d = 0.33). Eight-month cardiometabolic outcomes followed similar trends, but had high rates of missing data (45−53%) due to COVID-19 restrictions. Collectively, findings demonstrated favorable outcomes for acceptability and feasibility, while also highlighting key areas for refinement in future research.

Results of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention Among Midlife African American Women: Feasibility Trial.

BACKGROUND: Regular aerobic physical activity (PA) is an important component of healthy aging. However, only 27%-40% of African American women achieve national PA guidelines. Available data also show a clear decline in PA as African American women transition from young adulthood (ie, 25-44 years) into midlife. This decline in PA during midlife coincides with an increased risk for African American women developing cardiometabolic disease conditions, including obesity, type 2 diabetes, and cardiovascular disease. Thus, effective efforts are needed to promote PA among sedentary African American women during midlife. OBJECTIVE: This study aims to examine the acceptability and feasibility of a culturally tailored, smartphone-delivered PA intervention, originally developed to increase PA among African American women aged 24-49 years, among a slightly older sample of midlife African American women aged 50-65 years. METHODS: A single-arm pretest-posttest study design was implemented. In total, 20 insufficiently active African American (ie, ≤60 min per week of PA) women between the ages of 50-65 years participated in the 4-month feasibility trial. The Smart Walk intervention was delivered through the study Smart Walk smartphone app and text messages. Features available on the Smart Walk app include personal profile pages, multimedia PA promotion modules, discussion board forums, and an activity tracking feature that integrates with Fitbit activity monitors. Self-reported PA and social cognitive theory mediators targeted by the intervention (ie, self-regulation, behavioral capability, outcome expectations, self-efficacy, and social support) were assessed at baseline and at 4 months. Feasibility and acceptability were assessed using a postintervention satisfaction survey that included multiple-choice and open-ended questions evaluating participant perceptions of the intervention and suggestions for intervention improvement. Wilcoxon signed-rank tests were used to examine pre- and postintervention changes in the PA and social cognitive theory variables. The effect size estimates were calculated using the Pearson r test statistic. RESULTS: Participants increased moderate-to-vigorous PA (median 30 minutes per week increase; r=0.503; P=.002) and reported improvements in 2 theoretical mediators (self-regulation: r=0.397; P=.01; behavioral capability: r=0.440; P=.006). Nearly all participants (14/15, 93% completing the satisfaction survey) indicated that they would recommend the intervention to a friend. Participants' suggestions for improving the intervention included enhancing the intervention's provisions of social support for PA. CONCLUSIONS: The results provide preliminary support for the feasibility of the smartphone-based approach to increase PA among midlife African American women. However, before larger-scale implementation among midlife African American women, enhancements to the social support components of the intervention are warranted. TRIAL REGISTRATION: ClinicalTrials.gov NCT04073355; https://clinicaltrials.gov/ct2/show/NCT04073355.

A Culturally Relevant Smartphone-Delivered Physical Activity Intervention for African American Women: Development and Initial Usability Tests of Smart Walk.

BACKGROUND: Smart Walk is a culturally relevant, social cognitive theory-based, smartphone-delivered intervention designed to increase physical activity (PA) and reduce cardiometabolic disease risk among African American (AA) women. OBJECTIVE: This study aimed to describe the development and initial usability testing results of Smart Walk. METHODS: Smart Walk was developed in 5 phases. Phases 1 to 3 focused on initial intervention development, phase 4 involved usability testing, and phase 5 included intervention refinement based on usability testing results. In phase 1, a series of 9 focus groups with 25 AA women (mean age 38.5 years, SD 7.8; mean BMI 39.4 kg/m2, SD 7.3) was used to identify cultural factors associated with PA and ascertain how constructs of social cognitive theory can be leveraged in the design of a PA intervention. Phase 2 included the analysis of phase 1 qualitative data and development of the structured PA intervention. Phase 3 focused on the technical development of the smartphone app used to deliver the intervention. Phase 4 consisted of a 1-month usability trial of Smart Walk (n=12 women; mean age 35.0 years, SD 8.5; mean BMI 40 kg/m2, SD 5.0). Phase 5 included refinement of the intervention based on the usability trial results. RESULTS: The 5-phase process resulted in the development of the Smart Walk smartphone-delivered PA intervention. This PA intervention was designed to target social cognitive theory constructs of behavioral capability, outcome expectations, social support, self-efficacy, and self-regulation and address deep structure sociocultural characteristics of collectivism, racial pride, and body appearance preferences of AA women. Key features of the smartphone app included (1) personal profile pages, (2) multimedia PA promotion modules (ie, electronic text and videos), (3) discussion boards, and (4) a PA self-monitoring tool. Participants also received 3 PA promotion text messages each week. CONCLUSIONS: The development process of Smart Walk was designed to maximize the usability, cultural relevance, and impact of the smartphone-delivered PA intervention.

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.

Rationale and design of Smart Walk: A randomized controlled pilot trial of a smartphone-delivered physical activity and cardiometabolic risk reduction intervention for African American women.

BACKGROUND: African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. These disparities emphasize the need for innovative and effective interventions to increase PA and reduce cardiometabolic disease risk among AA women. Recent evidence suggests that mobile health (mHealth) interventions have the potential to increase PA and reduce cardiometabolic disease risk factors. Few studies have examined the efficacy of mHealth PA interventions among racial/ethnic minorities, including AA women. This represents a missed opportunity given the reported success of technology-delivered PA interventions in predominately White populations and the high use of technology among AA women. OBJECTIVE: To describe the design, theoretical rationale, and cultural relevance of Smart Walk, a culturally sensitive smartphone-delivered PA intervention for AA women. DESIGN AND METHODS: Smart Walk is an 8-month, randomized controlled pilot trial designed to increase PA and reduce cardiometabolic disease risk among AA women. Sixty physically inactive AA women with obesity will be assigned to receive either a culturally relevant intervention designed to increase PA (by targeting leisure-time, household chore/task-related, and occupational PA) or a culturally relevant wellness attention-matched control condition. Outcomes will be assessed at baseline, 4 months, and 8 months, and include feasibility and acceptability of the PA intervention and evaluation of effects on PA and cardiometabolic risk factors. SUMMARY: Smart Walk represents a culturally relevant, theory-based approach to promote PA and reduce cardiometabolic disease risk in AA women.

Validation of a Smartphone App for the Assessment of Sedentary and Active Behaviors.

BACKGROUND: Although current technological advancements have allowed for objective measurements of sedentary behavior via accelerometers, these devices do not provide the contextual information needed to identify targets for behavioral interventions and generate public health guidelines to reduce sedentary behavior. Thus, self-reports still remain an important method of measurement for physical activity and sedentary behaviors. OBJECTIVE: This study evaluated the reliability, validity, and sensitivity to change of a smartphone app in assessing sitting, light-intensity physical activity (LPA), and moderate-vigorous physical activity (MVPA). METHODS: Adults (N=28; 49.0 years old, standard deviation [SD] 8.9; 85% men; 73% Caucasian; body mass index=35.0, SD 8.3 kg/m2) reported their sitting, LPA, and MVPA over an 11-week behavioral intervention. During three separate 7-day periods, participants wore the activPAL3c accelerometer/inclinometer as a criterion measure. Intraclass correlation (ICC; 95% CI) and bias estimates (mean difference [δ] and root of mean square error [RMSE]) were used to compare app-based reported behaviors to measured sitting time (lying/seated position), LPA (standing or stepping at <100 steps/minute), and MVPA (stepping at >100 steps/minute). RESULTS: Test-retest results suggested moderate agreement with the criterion for sedentary time, LPA, and MVPA (ICC=0.65 [0.43-0.82], 0.67 [0.44-0.83] and 0.69 [0.48-0.84], respectively). The agreement between the two measures was poor (ICC=0.05-0.40). The app underestimated sedentary time (δ=-45.9 [-67.6, -24.2] minutes/day, RMSE=201.6) and overestimated LPA and MVPA (δ=18.8 [-1.30 to 38.9] minutes/day, RMSE=183; and δ=29.3 [25.3 to 33.2] minutes/day, RMSE=71.6, respectively). The app underestimated change in time spent during LPA and MVPA but overestimated change in sedentary time. Both measures showed similar directions in changed scores on sedentary time and LPA. CONCLUSIONS: Despite its inaccuracy, the app may be useful as a self-monitoring tool in the context of a behavioral intervention. Future research may help to clarify reasons for under- or over-reporting of behaviors.

Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults' physical activity.

BACKGROUND: Emerging interventions that rely on and harness variability in behavior to adapt to individual performance over time may outperform interventions that prescribe static goals (e.g., 10,000 steps/day). The purpose of this factorial trial was to compare adaptive vs. static goal setting and immediate vs. delayed, non-contingent financial rewards for increasing free-living physical activity (PA). METHODS: A 4-month 2 × 2 factorial randomized controlled trial tested main effects for goal setting (adaptive vs. static goals) and rewards (immediate vs. delayed) and interactions between factors to increase steps/day as measured by a Fitbit Zip. Moderate-to-vigorous PA (MVPA) minutes/day was examined as a secondary outcome. RESULTS: Participants (N = 96) were mainly female (77%), aged 41 ± 9.5 years, and all were insufficiently active and overweight/obese (mean BMI = 34.1 ± 6.2). Participants across all groups increased by 2389 steps/day on average from baseline to intervention phase (p < .001). Participants receiving static goals showed a stronger increase in steps per day from baseline phase to intervention phase (2630 steps/day) than those receiving adaptive goals (2149 steps/day; difference = 482 steps/day, p = .095). Participants receiving immediate rewards showed stronger improvement (2762 step/day increase) from baseline to intervention phase than those receiving delayed rewards (2016 steps/day increase; difference = 746 steps/day, p = .009). However, the adaptive goals group showed a slower decrease in steps/day from the beginning of the intervention phase to the end of the intervention phase (i.e. less than half the rate) compared to the static goals group (-7.7 steps vs. -18.3 steps each day; difference = 10.7 steps/day, p < .001) resulting in better improvements for the adaptive goals group by study end. Rate of change over the intervention phase did not differ between reward groups. Significant goal phase x goal setting x reward interactions were observed. CONCLUSIONS: Adaptive goals outperformed static goals (i.e., 10,000 steps) over a 4-month period. Small immediate rewards outperformed larger, delayed rewards. Adaptive goals with either immediate or delayed rewards should be preferred for promoting PA. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02053259 registered prospectively on January 31, 2014.

BeWell24: development and process evaluation of a smartphone "app" to improve sleep, sedentary, and active behaviors in US Veterans with increased metabolic risk.

Lifestyle behaviors across the 24-h spectrum (i.e., sleep, sedentary, and active behaviors) drive metabolic risk. We describe the development and process evaluation of BeWell24, a multicomponent smartphone application (or "app") that targets behavior change in these interdependent behaviors. A community-embedded iterative design framework was used to develop the app. An 8-week multiphase optimization strategy design study was used to test the initial efficacy of the sleep, sedentary, and exercise components of the app. Process evaluation outcomes included objectively measured app usage statistics (e.g., minutes of usage, self-monitoring patterns), user experience interviews, and satisfaction ratings. Participants (N = 26) logged approximately 60 % of their sleep, sedentary, and exercise behaviors, which took 3-4 min/day to complete. Usage of the sleep and sedentary components peaked at week 2 and remained high throughout the intervention. Exercise component use was low. User experiences were mixed, and overall satisfaction was modest.

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

BACKGROUND: Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. OBJECTIVE: Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. METHODS: Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. RESULTS: This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. CONCLUSIONS: The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of the first studies focusing on the individual components of combined goal setting and reward structures in a factorial design to increase walking. The trial is expected to produce results useful to future research interventions and perhaps industry initiatives, primarily focused on mHealth, goal setting, and those looking to promote behavior change through performance-based incentives. TRIAL REGISTRATION: ClinicalTrials.gov NCT02053259; https://clinicaltrials.gov/ct2/show/NCT02053259 (Archived by WebCite at http://www.webcitation.org/6b65xLvmg).