Cardiovascular HealthMHCNCT03090321
MyHeart Counts Cardiovascular Health Study
A study testing Stand Prompt, Step Prompt and Cluster Prompt in people with Cardiovascular Health, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Stand Prompt, Step Prompt and Cluster Prompt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults over the age of 18
Who cannot join
- Children under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Health
- Being tested
- Stand Prompt, Step Prompt, Cluster Prompt, Read AHA website
- Keywords
- fitness, health, activity, heart risk, wellness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand PromptBehavioural
Also called Behavior Change and Motivational Coaching-Stand Prompt
The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes
Step PromptBehavioural
Also called Behavior Change and Motivational Coaching- 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.
Cluster PromptBehavioural
Also called Behavior Change and Motivational Coaching- 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
Read AHA websiteBehavioural
Also called Behaviour Change and Motivational Coaching- Reminder to read the American Heart Association (AHA) website
Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm
| Study group | Role | What they receive |
|---|---|---|
| Stand Prompt | Active comparator | Behavioral Intervention Prompt- Participant will receive a notification asking them to stand and walk if they have been sitting for longer than 60 minutes. Receives: Behavioral: Stand Prompt |
| Step Prompt | Active comparator | The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps. Receives: Behavioral: Step Prompt |
| Cluster Prompt | Active comparator | 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. Receives: Behavioral: Cluster Prompt |
| Read AHA website | Placebo comparator | Daily reminder to read the American Heart Association (AHA) website. Receives: Behavioral: Read AHA website |
| Baseline monitoring | No intervention | No feedback is provided to the users. This is the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit)
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.
Measured: 5 weeks
Secondary outcomes (4)
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
Measured: 5 weeks
Change in responses ( to survey questions on self perceived risk of cardiovascular disease and well being (survey adopted from reference in description)
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.
Measured: 5 weeks
Change in sleep duration as measured by Apples core motion chip.
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.
Measured: 5 weeks
Change in self reported sleep duration obtained from a daily user survey.
The researchers will compare self reported sleep time at baseline vs end of each intervention week.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study startMar 2015
- Primary completionJul 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Euan Ashley, Stanford University
- Investigators
- Euan Ashley, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090321
- Sponsor's protocol ID
- 31409
- Acronym
- MHC
- Status last verified
- Mar 2025
- First submitted
- 14 Dec 2016
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual user data will not be shared, deidentified user data will be shared if the user has indicated that this is ok with them.
Publications
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/
PubMed 24600748Knowles 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.
PubMed 22715281Hershman 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.
PubMed 30975992McConnell 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.
PubMed 27973671Shcherbina 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.
PubMed 33323209Javed 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.
PubMed 37794870
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyHeart Counts Cardiovascular Health Study
- ClinicalTrials.gov ID
- NCT03090321
- Acronym / sponsor ID
- MHC / 31409
- Conditions
- Cardiovascular Health
- Keywords
- fitness, health, activity, heart risk, wellness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stand Prompt | Active comparator | Behavioral: Stand PromptBehavioral Intervention Prompt- Participant will receive a notification asking them to stand and walk if they have been sitting for longer than 60 minutes. |
| Step Prompt | Active comparator | Behavioral: Step PromptThe participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps. |
| Cluster Prompt | Active comparator | Behavioral: Cluster PromptThe 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 | Placebo comparator | Behavioral: Read AHA websiteDaily reminder to read the American Heart Association (AHA) website. |
| Baseline monitoring | No intervention | –No feedback is provided to the users. This is the control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults over the age of 18
Key exclusion criteria (1 listed)
- Children under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand PromptAlso: Behavior Change and Motivational Coaching-Stand PromptThe participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes | Behavioural | Stand Prompt |
| Step PromptAlso: Behavior Change and Motivational Coaching- Step PromptThe participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps. | Behavioural | Step Prompt |
| Cluster PromptAlso: Behavior Change and Motivational Coaching- Cluster PromptThe 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 | Behavioural | Cluster Prompt |
| Read AHA websiteAlso: Behaviour Change and Motivational Coaching- Reminder to read the American Heart Association (AHA) websiteDaily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm | Behavioural | Read AHA website |
Primary outcome
Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit)
Time frame: 5 weeks
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.
4 secondary outcomes
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
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
Change in sleep duration as measured by Apples core motion chip.
Time frame: 5 weeks
Change in self reported sleep duration obtained from a daily user survey.
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 24600748Organisation 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/
- Background: PubMed 22715281Knowles 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.
- Background: PubMed 30975992Hershman 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.
- Background: PubMed 27973671McConnell 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.
- Background: PubMed 33323209Shcherbina 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.
- Derived from this study: PubMed 37794870Javed 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.
- Individual participant dataSharing planned: Yes. Individual user data will not be shared, deidentified user data will be shared if the user has indicated that this is ok with them.
Related trials for Cardiovascular Health
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Euan Ashley, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand Prompt, Step Prompt and Cluster Prompt in people with Cardiovascular Health, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity frequency and duration as Measured By Smartphone Core Motion Chip Sensor (Step count as seen in Apple's Healthkit) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03090321, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.