An mHealth Mobile Application Supporting Maintenance of Physical Activity Among Men and Women With High Blood Pressure (HeartSteps)
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|ClinicalTrials.gov Identifier: NCT03937674|
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity||Behavioral: HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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)|
|Official Title:||Heart Steps: Adaptive mHealth Intervention for Physical-Activity Maintenance|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: HeartSteps Intervention
For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not.
Behavioral: HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults.
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.
- 30 minute step count [ Time Frame: 30 minutes ]step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.
- Daily step count [ Time Frame: 24 hours ]Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.
- MVPA [ Time Frame: 24 hours ]Number of minutes of moderate or vigorous physical activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937674
|United States, Washington|
|Kaiser Permanente Washington Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Pedja V Klasnja, PhD||Kaiser Permente Washington Health Research Institute|