MyHeart Counts Cardiovascular Health Study

NCT ID: NCT03090321

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

2000000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Stand Prompt

Intervention Type BEHAVIORAL

The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes

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.

Group Type ACTIVE_COMPARATOR

Step Prompt

Intervention Type BEHAVIORAL

The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps.

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.

Group Type ACTIVE_COMPARATOR

Cluster Prompt

Intervention Type BEHAVIORAL

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

Read AHA website

Daily reminder to read the American Heart Association (AHA) website.

Group Type PLACEBO_COMPARATOR

Read AHA website

Intervention Type BEHAVIORAL

Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm

Baseline monitoring

No feedback is provided to the users. This is the control arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stand Prompt

The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Read AHA website

Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavior Change and Motivational Coaching-Stand Prompt Behavior Change and Motivational Coaching- Step Prompt Behavior Change and Motivational Coaching- Cluster Prompt Behaviour Change and Motivational Coaching- Reminder to read the American Heart Association (AHA) website

Eligibility Criteria

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Inclusion Criteria

* All adults over the age of 18

Exclusion Criteria

* Children under the age of 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Euan Ashley

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Euan Ashley, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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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/

Reference Type BACKGROUND
PMID: 24600748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22715281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30975992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27973671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33323209 (View on PubMed)

Javed A, Kim DS, Hershman SG, Shcherbina A, Johnson A, Tolas A, O'Sullivan JW, McConnell MV, Lazzeroni L, King AC, Christle JW, Oppezzo M, Mattsson CM, Harrington RA, Wheeler MT, Ashley EA. Personalized digital behaviour interventions increase short-term physical activity: a randomized control crossover trial substudy of the MyHeart Counts Cardiovascular Health Study. Eur Heart J Digit Health. 2023 Aug 9;4(5):411-419. doi: 10.1093/ehjdh/ztad047. eCollection 2023 Oct.

Reference Type DERIVED
PMID: 37794870 (View on PubMed)

Other Identifiers

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31409

Identifier Type: -

Identifier Source: org_study_id

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