386 Participants Needed

Digital Health Tool for Physical Activity

(YourMove Trial)

SA
MH
Overseen ByMichael Higgins, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this 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 increase weekly amounts of Moderate to Vigorous Physical Activity (MVPA) over 12 months among adults compared to a digital health intervention that mimics a standard of care corporate wellness program.

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 data supports the effectiveness of the COT-Based Intervention treatment in the Digital Health Tool for Physical Activity trial?

Research shows that using digital tools like smartphone apps and activity trackers can increase physical activity levels. In a study with patients having COPD or type 2 diabetes, a similar tool increased daily physical activity and improved quality of life scores, suggesting that digital health tools can effectively boost physical activity.12345

Is the Digital Health Tool for Physical Activity generally safe for humans?

Research on physical activity interventions, including those using digital tools, shows that serious adverse events are rare, with only minor issues like muscle injuries reported. These studies emphasize starting with low intensity and gradually increasing activity to ensure safety.36789

How does the COT-Based Intervention treatment differ from other treatments for increasing physical activity?

The COT-Based Intervention is unique because it uses a digital health tool that combines an accelerometer, smartphone app, and web application to provide continuous feedback and personalized goals for physical activity, which is set in collaboration with healthcare providers. This approach integrates technology with behavior change counseling, making it distinct from traditional methods that may not offer real-time monitoring and tailored feedback.1241011

Research Team

EH

Eric Hekler, PhD

Principal Investigator

University of California, San Diego

DR

Daniel Rivera, PhD

Principal Investigator

Arizona State University

Eligibility Criteria

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
See 5 more

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

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

Treatment Details

Interventions

  • COT-Based Intervention
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: COT-Based InterventionExperimental Treatment1 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: ControlActive Control1 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).

Find a Clinic Near You

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+

Findings from Research

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

References

A pilot study of a tool to stimulate physical activity in patients with COPD or type 2 diabetes in primary care. [2022]
Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression. [2021]
Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial. [2022]
Technology combined with a counseling protocol to stimulate physical activity of chronically ill patients in primary care. [2014]
Effectiveness of a Web 2.0 Intervention to Increase Physical Activity in Real-World Settings: Randomized Ecological Trial. [2019]
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]
Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]
Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]
[Objective measurement of physical activity in adults]. [2012]
Process evaluation of physical activity counselling with and without the use of mobile technology: A mixed methods study. [2016]
Measurement and Assessment of Physical Activity by Information and Communication Technology. [2018]