Digital Health Tool for Physical Activity

(YourMove Trial)

Overseen By Michael Higgins, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Psychiatric conditions, Medical implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital health tool that uses a phone and smartwatch to encourage adults to be more active. The goal is to determine if this tool, called the COT-Based Intervention, increases weekly moderate to vigorous physical activity compared to a regular corporate wellness program. Participants will either engage in an experimental program with personalized goals and rewards or follow a standard approach using a fitness tracker. It suits those who are generally healthy, can use a smartphone, and are willing to be active for 12 months. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance personal health and wellness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on your ability to participate in physical activity and use digital tools.

What prior data suggests that this digital health tool is safe for increasing physical activity?

Research has shown that mobile apps encouraging physical activity are generally safe, though they might cause minor issues such as small aches or temporary discomfort from increased activity. Studies indicate that digital health tools can enhance the safety and quality of health care. However, minor side effects may occur as activity levels rise. Overall, digital health programs like the COT-Based Intervention are well-received and designed to safely increase physical activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COT-based intervention for boosting physical activity because it takes a personalized approach that adapts daily step goals based on individual progress, unlike standard options that set static goals. This intervention motivates participants with dynamic feedback and rewards like points redeemable for gift cards, enhancing engagement. Additionally, it incorporates a unique self-experimentation tool, REFLECT, which aims to bolster personal motivation and self-regulation, potentially leading to more sustainable lifestyle changes compared to traditional digital wellness programs.

What evidence suggests that this digital health tool is effective for increasing physical activity?

Research shows that digital health tools can help people become more active. A review of 22 studies found these tools effectively encourage people, especially older adults, to move more. In this trial, participants may receive the COT-Based Intervention, which functions like a personal health coach. It sets step goals that are both challenging and achievable, providing feedback and rewards such as gift cards. This personalized approach aims to motivate people to increase their daily steps and exercise time each week. Although some studies have mixed results, evidence suggests these digital tools can effectively encourage more physical activity. ^{3 6 7 8 9}

Who Is on the Research Team?

Eric Hekler, PhD

Principal Investigator

University of California, San Diego

Daniel Rivera, PhD

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

This trial is for adults aged 25-80 who are healthy enough to be active, can use a smartwatch and app, and have a BMI of 18-40. They must commit to a year-long program and attend three check-ups. It's not for those in other activity programs, with conditions affecting participation or with devices like pacemakers.

Inclusion Criteria

Intend to be available for a 12-month intervention

Willing and able to use a smartphone and text messaging

Willing and able to use the wearable and corresponding app

Exclusion Criteria

Those with a mechanical medical implant, such as a pacemaker

Psychiatric or medical conditions that prohibit compliance with the study protocol

Enrolled in or planning to enroll in a physical activity program during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a digital health tool to increase physical activity over 12 months

12 months

Regular monitoring via wearable devices and app

Follow-up

Participants are monitored for changes in physical activity and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COT-Based Intervention

Trial Overview The study tests a new mobile health tool that pairs with your phone and watch to boost physical activity over the course of a year. It will be compared against standard digital wellness programs to see if it helps people do more moderate-to-vigorous exercise.

How Is the Trial Designed?

Group I: COT-Based Intervention Experimental Treatment 1 Intervention

The COT-based intervention will include the following to improve both steps/day (move more), and improving minutes/week of MVPA (exercise): adaptive daily steps/day goal-setting plus feedback; positive reinforcement (i.e., points, which translate to gift cards), self-monitoring of both steps/day and min/week MVPA; education about MVPA sent via text message in both conditions; planning support for scheduling bouts of MVPA via SMS in both conditions; and motivational messages sent via SMS in both conditions, and the use of a self-experimentation tool (REFLECT), developed based on prior successful pilot efforts, focused on fostering effective self-regulatory capacities of individuals.

Group II: Control Active Control 1 Intervention

The non-COT approach was designed to be an equivalent to emerging standard of care options for digital health worksite wellness programs to increase PA (control) for a 12-month study period. Participants assigned to the non-COT-based (control) group will receive the latest Fitbit Versa smartwatch and will download the Fitbit smartphone app. Unlike the intervention group, the daily step goal and the accompanying number of points will be static (10,000 steps/day; 150 points/day, respectively). The goal will be delivered to participants via the standard Fitbit app features and points will be communicated via email. Participants will also receive a weekly PA goal (150 minutes of MVPA/per week) and the same accompanying motivational and informative texts that the intervention group receives. Control participants will not complete the physical activity and exercise reflection and planning exercise (Reflect).

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Small Steps Labs, LLC

Collaborator

Trials

3

Recruited

1,100+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

A systematic review of 35 studies involving 7454 participants found that mobile app and tracker interventions led to a small-to-moderate increase in physical activity, equating to an average of 1850 additional steps per day.

Interventions that included text messaging and personalized features were particularly effective, suggesting that these elements enhance user engagement and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. Laranjo, L., Ding, D., Heleno, B., et al.[2021]

The monitoring-and-feedback tool, which includes an activity monitor and a counseling protocol, was well-received by both patients and nurses, with 88% of patients using it throughout the intervention period.

Patients using the tool reported greater improvements in physical activity levels and increased awareness and enjoyment of their exercise routines compared to those who did not use the tool, despite encountering technical issues in 58% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of physical activity counselling with and without the use of mobile technology: A mixed methods study. Verwey, R., van der Weegen, S., Spreeuwenberg, M., et al.[2016]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618011/

Effectiveness of Digital Health Interventions in Promoting ... Recent studies offer conflicting conclusions about the effectiveness of digital health interventions in changing physical activity behaviors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397713/

Optimizing and Testing an Individualized and Adaptive ... Similarly to an effective health coach, our COT-based intervention has the following capabilities: (1) ambitious and achievable step goals based on participant- ...

3. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-024-01694-4

a systematic umbrella review and meta-meta-analysis Evidence from 22 reviews and meta-analyses suggests that digital physical activity interventions are effective at increasing physical activity in older adults.

4. withpower.com withpower.com/trial/phase-inactivity-physical-9-2022-c9f12

Digital Health Tool for Physical Activity (YourMove Trial) The purpose of this study is to determine the efficacy of a new digital health tool that uses a phone and smartwatch to encourage physical activity and ...

5. publichealth.jmir.org publichealth.jmir.org/2022/5/e37820

Evaluation of Digital Interventions for Physical Activity Promotion We aimed to investigate evaluation strategies in the context of digital interventions for physical activity promotion using a scoping review of published ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454192/

The Effect and Safety of App-Based Interventions for ... A systematic review and meta-analysis published in 2022 found that mobile apps supporting therapeutic exercise or tailored physical activity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9403754/

The cost-effectiveness of digital health interventions Digital health interventions have significant potential to improve safety, efficacy, and quality of care, reducing waste in healthcare costs.

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887123005125

Benefits and Harms of Digital Health Interventions ... ... safety is paramount when initiating a digital physical activity intervention. We found an increased risk of nonserious events in the intervention groups ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.787135/full

The cost-effectiveness of digital health interventions Background: Digital health interventions have significant potential to improve safety, efficacy, and quality of care, reducing waste in healthcare costs.