MyHeart Counts: Stanford Mobile Cardiovascular Health Study 3.0

NCT04183010 | Withdrawn

• 1 other identifier: 54220
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

MyHeart Counts is a smartphone-based mobile cardiovascular health research study. It will use 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 largely go unmeasured. These can now be measured with sensors in phones or wearable devices as we have shown on iOS. With the large number of smartphone users addressable with a HIPAA complaint iOS \& Android platform, the investigators aim to collect activity and cardiovascular health data on many more subjects than in prior studies as well as provide much more quantitative data on type, duration, and intensity of daily activities. It also provides a platform to investigate methods to help participants increase heart-healthy activities. The study also includes a randomized controlled trial on physical activity. The overall goal is to develop an extensive source of data to help inform future cardiovascular health guidelines.

Conditions

Cardiovascular Health

Outcome Measures

Primary Outcomes (1)

• Change in daily step count

  Change in daily steps from the iPhone computed via HealthKit and from Android via Google Fit

  Measured daily for a period of 12 weeks, including 1 week of baseline monitoring and during the 11 week duration of the randomized arms.

Secondary Outcomes (4)

• Compliance

  Measured once at the end of the study, covering the 11 week duration of coaching.

• Change in resting heart rate

  Measured monthly during the 12 week duration of the study

• Change in recovery heart rate

  Measured monthly during the 12 week duration of the study

• Change in daily self-reported happiness

  Measured daily during the 12 week duration of the study.

Study Arms (2)

Control

NO INTERVENTION

At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. Both arms will continue to receive their seven day physical activity assessment using the phone's core motion sensors and HealthKit/ Google Health step count. Both groups will also be prompted to complete monthly fitness tests: the 6-minute walk test, a 12 minute run test, and the Tecumseh step test.

Physical activity coaching

EXPERIMENTAL

In addition to the tasks performed and feedback received by the Control arm (see above), the intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options: * Low intensity activity options (i.e. walking in the part, bicycling to the store, etc.). * Moderate to vigorous endurance activity, performed on their own (running, bicycling, rowing, swimming, etc) * An on demand "group session" video * No exercise today * Alternate physical activity -- the participants will have the option to record alternate physical activity that they performed Participants will be asked to indicate if they completed the exercise with three options: * Yes * No * Request for a different exercise to be shown

Behavioral: Physical activity coaching

Interventions

Physical activity coaching BEHAVIORAL

Interventions will be delivered via smartphone and will consist of physical activity coaching. Once randomized to the Coaching arm, individuals will be presented with seven broad categories of physical activity. They will receive a daily notification on their phone indicating that they have study activities to complete. They will then click on this notification and will be offered five options: 1. A low intensity activity from one of the categories they selected upon start of coaching 2. A moderate-to-vigorous endurance activity 3. The participant will be linked to video content with exercise tutorials/video coaching 4. Option to skip exercise that day 5. Option to fill in a different activity that the participant completed (free text entry) The participant will then select one of these options and complete the chosen activity. They will be presented with the question "Did you completed the exercise" with three options: 1. Yes 2. No 3. "Give me a different exercise"

Physical activity coaching

Eligibility Criteria

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

You may qualify if:

• Age 18+
• Daily access to smartphone (iPhone or Android)
• Living in the US during the duration of the study
• Ability to understand written English

You may not qualify if:

• International participants
• Children (under 18)

Sponsors & Collaborators

• Stanford University: lead
• Google LLC.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• App download link for MyHeart Counts app

Study Officials

• Euan A Ashley, MRCP, DPhil

  Stanford University

  PRINCIPAL INVESTIGATOR

• Anders Johnson

  Stanford University

  STUDY DIRECTOR

• Alex Tolas

  Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told if they are assigned to the control arm or the coaching arm of the study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean, School of Medicine, Professor of Medicine (cardiovascular), of Genetics, of Biomedical Data Science and, by courtesy, of Pathology at the Stanford University Medical Center

Model Details: Study participants will download the MyHeart Counts 3.0 app from their smartphone app store. They will undergo electronic consent, followed by a week of baseline monitoring, during which the phone will track their step count and acceleration. Participants will additionally complete questionnaires about their lifestyle and any risk factors for cardiovascular disease. At the end of this initial week of monitoring, participants will be randomized to a control group or an intervention group. Both groups will be followed for three months, with outcome measurements collected monthly. The intervention arm will also undergo daily coaching with the goal of increasing their daily step count. Members of this arm will receive daily app notifications indicating that they have activities to complete. They will be provided with 5 exercise options.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 2, 2019
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2026
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Upon completion of the study, a publication will be created to share the study findings. The data release will accompany this publication. We anticipate the publication/data release to be completed within 6-8 months following study completion.
• Access Criteria: All qualified researchers, as determined by criteria defined on synapse.org, will be eligible to access the data.

Locations

US (1)