MyHeart Counts Cardiovascular Health Study (MHC)
The MyHeart Counts Cardiovascular Health Study will utilize mobile health capabilities of smartphones and wearables to assess daily activity measures of the general population and compare these to measures of cardiovascular health risk factors and fitness. How people divide their time among exercise, sedentary behavior, and sleep all affect cardiovascular health, yet to date these have largely gone unmeasured. With the advancement of phone sensors and wearable fitness tracking devices these factors are now more straightforward to gather and measure. The use of smartphones by a large segment of the population allows for data collection on an unprecedented scale. The investigators aim to amass activity and cardiovascular health data on thousands of participants as well as provide significantly more quantitative data on type,duration, and intensity of daily activities.
In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment of Physical Activity Prompts In A Large Ambulatory Population) the researchers will conduct a randomized controlled clinical trial of four different physical activity prompts (intervention) and their effect on the level of physical activity in the study population as measured by change in step count.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
MyHeart Counts Cardiovascular Health Study is a smartphone-based mobile cardiovascular health research study. The study will utilize the mobile health capabilities of smartphones and wearables to assess daily activity measures of the general public and compare these to measures of cardiovascular health - risk factors and fitness. How people divide their time among exercise, sedentary behavior, and sleep all affect cardiovascular health, yet these largely go unmeasured. With the advancement in phone sensors and wearables these factors are now more straightforward to gather and measure. The use of smartphones by a large segment of the population allows for data collection on an unprecedented scale. The investigators aim to amass activity and cardiovascular health data on thousands of participants as well as provide much more quantitative data on type,duration, and intensity of daily activities. The MyHeart Counts Cardiovascular Health mobile application provides a platform for the investigation of methods aimed to aid participants in increasing heart healthy activities. The overall goal of the study is to develop an extensive source of data which will inform future cardiovascular health guidelines.
In the second phase of the MyHeart Counts Cardiovascular Health Study (Randomized Assessment of Physical Activity Prompts In A Large Ambulatory Population) the investigators will conduct a randomized controlled clinical trial of four different physical activity prompts (intervention) and their effect on increasing physical activity in the study population as measured by change in step count.
Of note to supplement the activity data the investigators will ask participants who have completed a genetic analysis to share their that data with the MyHeart Counts Cardiovascular Health Study research team. The investigators believe the opportunity to overlay activity, heart risk and genetic data for participants is a great tool for discovery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adults over the age of 18
Exclusion Criteria:
- Children under the age of 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Stand Prompt
Behavioral Intervention Prompt- Participant will receive a notification asking them to stand and walk if they have been sitting for longer than 60 minutes.
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The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes
Other Names:
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Active Comparator: Step Prompt
The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps.
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The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps.
Other Names:
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Active Comparator: Cluster Prompt
The participant will receive daily information notifications specific to the activity cluster they fall into based on the activity data collected in phase 1 of the study.
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The participant will receive daily information notifications specific to the activity cluster they fall into based on the activity data collected in phase 1 of the study
Other Names:
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Placebo Comparator: Read AHA website
Daily reminder to read the American Heart Association (AHA) website.
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Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm
Other Names:
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No Intervention: Baseline monitoring
No feedback is provided to the users.
This is the control arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit)
Time Frame: 5 weeks
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The researchers will compare step count data collected during baseline (or phase 1) week with step count data at the end of each of the 4 intervention weeks.
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5 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in self reported levels of happiness as indicated on a numerical gradient scale and self reported by participant using the OECD Guidelines on Measuring Subjective Well Being survey
Time Frame: 5 weeks
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5 weeks
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Change in responses ( to survey questions on self perceived risk of cardiovascular disease and well being (survey adopted from reference in description)
Time Frame: 5 weeks
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Each answer prompt on the survey is given a unique numerical value which is then added and averaged.
The researchers will investigate for changes in this score at baseline and during interventions.
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5 weeks
|
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Change in sleep duration as measured by Apples core motion chip.
Time Frame: 5 weeks
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The iphone is able to track sleep by sensing lack of motion between self reported sleeping and wake times.
The investigators will compare the average sleep time detected by phone at baseline and at the end of each intervention week.
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5 weeks
|
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Change in self reported sleep duration obtained from a daily user survey.
Time Frame: 5 weeks
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The researchers will compare self reported sleep time at baseline vs end of each intervention week.
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5 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Euan Ashley, MD, Stanford University
Publications and helpful links
General Publications
- Knowles JW, Assimes TL, Kiernan M, Pavlovic A, Goldstein BA, Yank V, McConnell MV, Absher D, Bustamante C, Ashley EA, Ioannidis JP. Randomized trial of personal genomics for preventive cardiology: design and challenges. Circ Cardiovasc Genet. 2012 Jun;5(3):368-76. doi: 10.1161/CIRCGENETICS.112.962746. No abstract available.
- Organisation for Economic Co-operation and Development (OECD). OECD Guidelines on Measuring Subjective Well-being. Paris: OECD Publishing; 2013 Mar 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK189560/
- Hershman SG, Bot BM, Shcherbina A, Doerr M, Moayedi Y, Pavlovic A, Waggott D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Salvi D, Landray M, Tarassenko L, Harrington RA, Yeung AC, McConnell MV, Ashley EA. Physical activity, sleep and cardiovascular health data for 50,000 individuals from the MyHeart Counts Study. Sci Data. 2019 Apr 11;6(1):24. doi: 10.1038/s41597-019-0016-7.
- McConnell MV, Shcherbina A, Pavlovic A, Homburger JR, Goldfeder RL, Waggot D, Cho MK, Rosenberger ME, Haskell WL, Myers J, Champagne MA, Mignot E, Landray M, Tarassenko L, Harrington RA, Yeung AC, Ashley EA. Feasibility of Obtaining Measures of Lifestyle From a Smartphone App: The MyHeart Counts Cardiovascular Health Study. JAMA Cardiol. 2017 Jan 1;2(1):67-76. doi: 10.1001/jamacardio.2016.4395.
- Shcherbina A, Hershman SG, Lazzeroni L, King AC, O'Sullivan JW, Hekler E, Moayedi Y, Pavlovic A, Waggott D, Sharma A, Yeung A, Christle JW, Wheeler MT, McConnell MV, Harrington RA, Ashley EA. The effect of digital physical activity interventions on daily step count: a randomised controlled crossover substudy of the MyHeart Counts Cardiovascular Health Study. Lancet Digit Health. 2019 Nov;1(7):e344-e352. doi: 10.1016/S2589-7500(19)30129-3. Epub 2019 Oct 9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 31409 (Other Identifier: Temple University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
product manufactured in and exported from the U.S.
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