Mobile Health Interventions for Cardiovascular Health

(MHC Trial)

Overseen By Anna Shcherbina, MEng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Children under 18

Compensation: Varies

Number of Visits: Unknown

2000000 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Mobile Health Interventions for Cardiovascular Health is an effective treatment?

The available research shows that Mobile Health Interventions, like frequent prompts to encourage physical activity, can effectively increase exercise adherence. For example, one study found that people who received frequent prompts were more likely to meet exercise goals compared to those who received less frequent prompts (46% vs. 13%). Additionally, physical activity is known to be as effective, or even more effective, than some drug treatments for managing cardiovascular health and other conditions. This suggests that using mobile health interventions to promote physical activity can be a powerful tool for improving cardiovascular health. ^{1 2 3 4 5}

What safety data exists for mobile health interventions for cardiovascular health?

The provided research does not directly address safety data for mobile health interventions specifically targeting cardiovascular health. However, it does highlight the effectiveness and feasibility of mobile health prompts and physical activity interventions in various contexts, such as diabetes prevention and physical activity promotion. These studies suggest that such interventions are generally effective and well-received, with no reported adverse effects, indicating a favorable safety profile. Further research specifically focused on cardiovascular health would be needed to provide more targeted safety data. ^{6 7 8 9 10}

Is the treatment 'Cluster Prompt, Read AHA website, Stand Prompt, Step Prompt' a promising treatment for cardiovascular health?

Yes, the treatment is promising because mobile health interventions, like prompts and text messages, can help people be more active and improve their heart health. These methods are easy to use and can reach many people, especially in areas with limited resources. ^{5 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Euan Ashley, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over the age of 18 who are interested in contributing to research on cardiovascular health. It aims to gather data using smartphones and wearables to track daily activities like exercise, sedentary behavior, and sleep.

Inclusion Criteria

I am over 18 years old.

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

Participants' baseline activity data is collected using smartphone sensors without any intervention

1 week

Remote monitoring via smartphone

Intervention

Participants receive different physical activity prompts to increase their activity levels, measured by change in step count

4 weeks

Remote monitoring via smartphone

Follow-up

Participants are monitored for changes in activity levels and cardiovascular health risk factors after the intervention

4 weeks

Treatment Details

Interventions

• Cluster Prompt
• Read AHA website
• Stand Prompt
• Step Prompt

Trial Overview The study tests four types of prompts (Stand Prompt, Step Prompt, Cluster Prompt, Read AHA website) designed to increase physical activity. Participants' step counts will be monitored to measure the effectiveness of these prompts.

Participant Groups

Group I: Cluster Prompt Active Control 1 Intervention

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 II: Baseline monitoring Active Control 1 Intervention

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

Group III: Stand Prompt Active Control 1 Intervention

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 IV: Step Prompt Active Control 1 Intervention

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

Group V: Read AHA website Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

The HeartSteps mHealth intervention, which provides contextually tailored walking suggestions, increased participants' step count by 14% on average, translating to about 35 additional steps after receiving a suggestion.

Walking suggestions were particularly effective at the beginning of the study, increasing step counts by 66% initially, but this effect decreased over time, while antisedentary suggestions did not show any significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Klasnja, P., Smith, S., Seewald, NJ., et al.[2022]

In a study of 135 participants in a walking program, those who received weekly phone prompts were significantly more likely to meet exercise goals (46%) compared to those prompted every three weeks (13%).

The structure of the prompts (high vs. low) did not show a significant difference in effectiveness, indicating that the frequency of reminders is more crucial for improving exercise adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Walking to meet health guidelines: the effect of prompting frequency and prompt structure. Lombard, DN., Lombard, TN., Winett, RA.[2019]

Physical inactivity is a major health risk factor, with 80% of US adults not meeting physical activity guidelines, leading to increased cardiovascular disease risk and other chronic conditions.

Promoting physical activity in healthcare settings can be as effective as drug interventions for preventing and managing over 40 health conditions, yet it is often overlooked in routine assessments compared to other cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine Assessment and Promotion of Physical Activity in Healthcare Settings: A Scientific Statement From the American Heart Association. Lobelo, F., Rohm Young, D., Sallis, R., et al.[2019]

The study involves 312 employed women aged 18-70 and uses a SMART design to test various interventions aimed at increasing physical activity and improving cardiovascular health, starting with either an enhanced activity monitor or a combination of the monitor and text messaging.

The research aims to identify which interventions are most effective for different responders, allowing for tailored approaches that maximize benefits for women who may need more intensive support to increase their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women. Buchholz, SW., Wilbur, J., Halloway, S., et al.[2021]

In a study involving 69 adults at risk for type II diabetes, personalized prompts sent through a mobile health app significantly increased self-monitoring and self-reported exercise behaviors in the 3 days following the prompts, particularly during the first half of the year after a diabetes prevention program.

The effectiveness of these prompts diminished over time, with no significant changes in exercise behaviors observed in the second half of the year, suggesting that optimizing the frequency of prompts could enhance user engagement and promote sustained exercise habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mobile Health Prompts on Self-Monitoring and Exercise Behaviors Following a Diabetes Prevention Program: Secondary Analysis From a Randomized Controlled Trial. MacPherson, MM., Merry, KJ., Locke, SR., et al.[2020]

Mobile health (mHealth) prompts, especially text messaging, are widely used in diabetes prevention programs, but their effectiveness on behavior change and diabetes incidence shows mixed results based on a review of 44 studies.

Participants generally received mHealth prompts positively, yet there is a lack of clarity on the theoretical basis for prompt design and timing, indicating a need for more rigorous research to optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. MacPherson, MM., Merry, KJ., Locke, SR., et al.[2022]

Telephone coaching significantly increased self-reported physical activity levels by about 173 minutes per week compared to a control group, and this effect was maintained at a 12-month follow-up.

The addition of SMS prompts did not provide any extra benefit in increasing physical activity levels beyond what was achieved with telephone coaching alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching and Prompting for Physical Activity: Short- and Long-Term Findings of a Randomized Controlled Trial (Movingcall). Fischer, X., Kreppke, JN., Zahner, L., et al.[2020]

In a study involving 52 women with stage II+ breast cancer, those who received a physical activity counseling session along with a Fitbit tracker (PAC+F) reported significantly higher levels of moderate to vigorous physical activity and total activity compared to those who only received counseling (PAC) after 12 weeks.

The PAC+F group not only self-reported higher activity levels but also showed objective improvements in measured physical activity, with over 80% of participants finding the Fitbit beneficial for maintaining their activity levels post-exercise intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer - A randomised controlled trial. Singh, B., Spence, RR., Sandler, CX., et al.[2020]

Physical activity is linked to lower mortality rates and reduced risk of non-communicable diseases, with evidence from randomized controlled trials and observational studies supporting these health benefits.

Recent studies using devices to measure physical activity highlight that all levels of activity are beneficial, and future guidelines may focus on age-specific recommendations and emphasize the importance of vigorous-intensity activities and daily step counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response associations, physical activity intensity and mortality risk: A narrative review. Ekelund, U., Sanchez-Lastra, MA., Dalene, KE., et al.[2023]

In a study of 39,294 adults with hypertension, higher levels of moderate-to-vigorous physical activity were associated with significantly lower risks of all-cause mortality and cardiovascular disease (CVD) incidence, with hazard ratios indicating a strong protective effect as activity levels increased.

The research demonstrated a clear dose-response relationship, showing that more physical activity correlates with lower risks of CVD and mortality, without any evidence of harm from high levels of activity, emphasizing the need for tailored physical activity guidelines for individuals with hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Associations of Accelerometer-Assessed Physical Activity With Mortality and Incidence of Cardiovascular Disease Among Adults With Hypertension: The UK Biobank Study. Del Pozo Cruz, B., Ahmadi, M., Inan-Eroglu, E., et al.[2023]

mHealth interventions significantly increase physical activity (PA) in adults, with moderate effect sizes observed across various measures such as walking and moderate-to-vigorous physical activity (MVPA) at the end of the intervention, involving 21,118 participants.

The positive effects of mHealth interventions on PA are maintained in the short and long term, particularly for walking and MVPA, although the effect size diminishes over time, highlighting the need for further rigorous studies due to the high risk of bias in the majority of included studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effectiveness of mHealth Physical Activity Interventions: Systematic Review and Meta-analysis of Randomized Controlled Trials. Mönninghoff, A., Kramer, JN., Hess, AJ., et al.[2021]

The addition of a mobile health (mHealth) intervention using SMS messaging to the Colorado Healthy Heart Solutions program led to a significant reduction in self-reported fat intake among participants, with a decrease of 26.3% compared to 10.6% in the control group (P = 0.001).

Participants who found the SMS messages motivating had better program retention, indicating that personalized messaging could enhance engagement in cardiovascular disease prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial of mobile short message service among participants in a rural cardiovascular disease prevention program. Gore, MO., Krantz, MJ., Albright, K., et al.[2020]

Text messaging-based mHealth interventions have shown effectiveness in improving various behavioral risk factors for cardiovascular disease, such as smoking cessation, weight loss, and blood pressure management.

While these interventions demonstrate short-term benefits, further research is necessary to assess the long-term sustainability of these effects and their impact on overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Text Messaging in Cardiovascular Risk Factor Optimization. Klimis, H., Khan, ME., Kok, C., et al.[2018]

A new mHealth intervention targeting African American women in resource-limited communities aims to increase physical activity (PA) over 6 months, using tailored messaging strategies to adapt to individual PA levels.

The study will assess the impact of these interventions on PA levels and cardiovascular disease (CVD) risk biomarkers, ensuring community involvement and ethical oversight throughout the research process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity. Tamura, K., Vijayakumar, NP., Troendle, JF., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Walking to meet health guidelines: the effect of prompting frequency and prompt structure. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Routine Assessment and Promotion of Physical Activity in Healthcare Settings: A Scientific Statement From the American Heart Association. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women. [2021]

5. Canada pubmed.ncbi.nlm.nih.gov

Effects of Mobile Health Prompts on Self-Monitoring and Exercise Behaviors Following a Diabetes Prevention Program: Secondary Analysis From a Randomized Controlled Trial. [2020]

6. China pubmed.ncbi.nlm.nih.gov

mHealth prompts within diabetes prevention programs: a scoping review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Telephone-Based Coaching and Prompting for Physical Activity: Short- and Long-Term Findings of a Randomized Controlled Trial (Movingcall). [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and effect of a physical activity counselling session with or without provision of an activity tracker on maintenance of physical activity in women with breast cancer - A randomised controlled trial. [2020]

9. China pubmed.ncbi.nlm.nih.gov

Dose-response associations, physical activity intensity and mortality risk: A narrative review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Prospective Associations of Accelerometer-Assessed Physical Activity With Mortality and Incidence of Cardiovascular Disease Among Adults With Hypertension: The UK Biobank Study. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Long-term Effectiveness of mHealth Physical Activity Interventions: Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

A controlled trial of mobile short message service among participants in a rural cardiovascular disease prevention program. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

The Role of Text Messaging in Cardiovascular Risk Factor Optimization. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity. [2021]