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Trial record 2 of 2 for:    HeartSteps

An mHealth Mobile Application Supporting Maintenance of Physical Activity Among Men and Women With High Blood Pressure (HeartSteps)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937674
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
University of Michigan
University of California, San Diego
Harvard University
Information provided by (Responsible Party):
Kaiser Permanente

Brief 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. Daily step count [ Time Frame: 24 hours ]
    Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.


Secondary Outcome Measures :
  1. MVPA [ Time Frame: 24 hours ]
    Number of minutes of moderate or vigorous physical activity



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • Recent blood pressure readings that falls in the stage 1 hypertension range by new AHA/ACC guidelines [>= 130 systolic]
  • Owns an iPhone
  • Able to walk for 10 minutes without pain
  • Expresses desire during study screen to increase physical activity

Exclusion Criteria:

  • Taking hypertension meds
  • Any diagnosis where physical activity would be counterindicated
  • Recent acute cardio vascular event
  • Major psychiatric illness

Information from the National Library of Medicine

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


Locations
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United States, Washington
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
University of Michigan
University of California, San Diego
Harvard University
Investigators
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Principal Investigator: Pedja V Klasnja, PhD Kaiser Permente Washington Health Research Institute
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03937674    
Other Study ID Numbers: 1257484
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified dataset (i.e., containing no raw location/GPS information) will be generated and made available to the research community. The dataset will be stripped of all codes or any other information that could be linked back to the original data or to an individual participant. Prospective users of this dataset must agree to a confidentiality agreement, meaning that they must get permission from the HeartSteps Primary Investigator to share the data with anyone else. All external requests for data will be directed to Dr. Predrag Klasnja. Prospective investigators will submit a written proposal to the HeartSteps Investigator Team outlining the question they will investigate, the specific variables that they need to answer that question, their analytic plan for answering that question, and documentation of sufficient Institutional Review Board oversight (e.g., approval or exemption). Investigators will also need to sign a confidentiality agreement.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaiser Permanente:
Physical Activity
Mobile Health
Self Monitoring
Wearable Sensors
Tailored Health Communication
Implementation Intentions
Mobile Apps
Anti-Sedentary Behavior
Opportunistic Physical Activity
Health Belief Model