MyHeart Counts Cardiovascular Health Study

NCT03090321 | Active Not Recruiting

• 1 other identifier: 31409
• Study Type: interventional
• Target: 2,000,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Health

Keywords

fitness; health; activity; heart risk; wellness

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  5 weeks

• Change in responses ( to survey questions on self perceived risk of cardiovascular disease and well being (survey adopted from reference in description)

  5 weeks

• Change in sleep duration as measured by Apples core motion chip.

  5 weeks

• Change in self reported sleep duration obtained from a daily user survey.

  5 weeks

Study Arms (5)

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.

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.

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.

Behavioral: Cluster Prompt

Read AHA website

PLACEBO COMPARATOR

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

Behavioral: Read AHA website

Baseline monitoring

NO INTERVENTION

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

Interventions

Stand Prompt BEHAVIORAL

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

Also known as: Behavior Change and Motivational Coaching-Stand Prompt

Stand Prompt

Step Prompt BEHAVIORAL

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

Also known as: Behavior Change and Motivational Coaching- Step Prompt

Step Prompt

Cluster Prompt 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

Also known as: Behavior Change and Motivational Coaching- Cluster Prompt

Cluster Prompt

Read AHA website BEHAVIORAL

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

Also known as: Behaviour Change and Motivational Coaching- Reminder to read the American Heart Association (AHA) website

Read AHA website

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults over the age of 18

You may not qualify if:

• Children under the age of 18

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (6)

• 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/

  PMID: 24600748 BACKGROUND

• 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.

  PMID: 22715281 BACKGROUND

• 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.

  PMID: 30975992 BACKGROUND

• 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.

  PMID: 27973671 BACKGROUND

• 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.

  PMID: 33323209 BACKGROUND

• 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.

  PMID: 37794870 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

acetohydroxamic acid

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Euan Ashley, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: March 24, 2017
• Study Start: March 1, 2015
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 29, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)