An mHealth Mobile Application Supporting Maintenance of Physical Activity Among Men and Women With High Blood Pressure
Condition: Physical Activity
Study type: Interventional

Summary: 
      The aim of this research is to evaluate the efficacy of contextually tailored activity
      suggestions and activity planning for increasing physical activity among sedentary adults.
    

Detailed description: 
      This project file refers to Aim 2 and Aim 3 of the National Heart, Lung, and Blood Institute
      (NHLBI) grant. Aim 1 is registered in clinical trials.gov under a separate project file
      number, NCT03225521.

      Many of the risk factors for heart disease are behavioral, such as physical inactivity,
      smoking, and diets high in saturated and trans-fats. Prevention programs are effective at
      helping patients make the initial lifestyle changes needed to reduce their risks, but
      patients often struggle to maintain those changes.

      In this study the investigators propose to develop a novel mHealth application for supporting
      maintenance of physical activity. Kaiser Permanente Washington Health Research Institute
      (KPWHRI) will conduct a prospective study to test the application among Kaiser Permanente
      Washington (KPW) men and women with blood pressure that falls in the stage 1 hypertension
      range. By taking advantage of the frequent interactions that individuals have with their
      mobile phones throughout the day, the investigators will design and evaluate an adaptive,
      personalized application that (1) keeps patients reminded of their health goals and
      motivations; (2) provides actionable ideas for how patients can be active right now, given
      their current context; and (3) helps patients plan and reflect on their physical activity to
      enable creation of robust and sustainable physical-activity habits. In addition, the
      application will adapt its functioning for each patient over time in order to minimize user
      burden while optimizing its ability to encourage physical activity and maintain engagement
      with the intervention.

      Through three Specific Aims-intervention development, intervention optimization, and pilot
      evaluation-this project will contribute: (1) understanding of how burden and intervention
      engagement change over time and how they are influenced by intervention delivery and
      patients' behavior and context; (2) generalization of learning algorithms that are used to
      personalize web content based on users' characteristics and past behavior for use in mHealth
      interventions for behavioral maintenance; and (3) new insights about how reflective and
      automated self-regulatory processes interact over time to support behavioral maintenance and
      how to optimally recruit these processes through an mHealth intervention.

      Aim 2: Optimize intervention and investigate influences on participant response.

      The investigators will conduct a three-month micro-randomized pilot study within-subject
      field study with 40-50 participants with blood pressure readings that fall in the stage 1
      hypertension range. Goals for this aim include (1) perform in-situ usability and
      user-experience testing of the intervention; (2) finalize and tune the intervention's
      learning algorithms; (3) develop initial decision rules for when and for whom individual
      intervention components will be provided; and (4) begin to investigate how participants'
      physical activity, burden, and patterns of engagement with the intervention are affected by
      different intervention features and the context of use.

      Aim 3: Pilot the personalized just-in-time adaptive mHealth intervention over 9 months The
      investigators will conduct a 9 month-long single-arm pilot study of adaptive mHealth
      intervention for physical-activity maintenance with 50-60 participants with blood pressure
      readings that falls in the stage 1 hypertension range. The investigators will (1) evaluate
      the feasibility and acceptability of the intervention for use over the course of nine months;
      (2) assess the ability of the learning algorithms to personalize intervention delivery over
      time; and (3) investigate how cardiac patients' responses to the intervention-physical
      activity, burden, and engagement-change over time as functions of time-varying application
      use and time-varying contextual factors. The study will also enable the investigators to
      gather empirical evidence to plan a follow-up RCT to test the efficacy of the intervention.
      Development of effective mHealth interventions requires advancements in and collaboration
      between computer science, human-computer interaction, and behavioral and health sciences.
      This project makes contributions to all three disciplines and deepens understanding of how to
      design personalized, adaptive interventions that help individuals not only to adopt but also
      sustain health-promoting behavior changes over the long-term.

      Aim 2 and Aim 3 activities will take place sequentially. The recruitment and participant
      experience will be almost identical. Differences beyond scientific objectives between the Aim
      2 and Aim 3 groups is the time each group is enrolled in the testing trial. Slight
      modifications are made to materials due to the difference in enrollment time.

      No hypotheses will be tested. The purpose of both studies is to develop and test for
      usability and acceptability of an mHealth application that supports maintenance of physical
      activity of patients with high blood pressure.
    

Intervention name(s): HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults.
Intervention type(s): Behavioral
Intervention description(s): HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.
Intervention model: Single Group Assignment
Intervention model description: At each "decision time"-a time point when an intervention component can be delivered-each day of the study each participant is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; morning motivational message or no motivational message)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; Mobile Health; Self Monitoring; Wearable Sensors; Tailored Health Communication; Implementation Intentions; Mobile Apps; Anti-Sedentary Behavior; Opportunistic Physical Activity; Health Belief Model