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Digital Health Tool for Physical Activity (YourMove Trial)
N/A
Waitlist Available
Led By Daniel Rivera, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a digital health tool to help adults become more physically active over 12 months.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves increasing physical activity through technology, side effects might include typical exercise-related issues such as muscle soreness or strain but should otherwise have minimal risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in minutes of moderate-to-vigorous physical activity (MVPA)
Secondary study objectives
Anxiety
Change in Body Mass Index (BMI)
Gait
+27 moreOther study objectives
Alcohol Use Disorder
Smoke
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,565 Total Patients Enrolled
5 Trials studying Sedentary Lifestyle
173 Patients Enrolled for Sedentary Lifestyle
Small Steps Labs, LLCUNKNOWN
2 Previous Clinical Trials
718 Total Patients Enrolled
Arizona State UniversityOTHER
298 Previous Clinical Trials
107,551 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 25 and 80 years old.I can attend 3 check-ups over the next year.I can walk and do moderate exercises.
Research Study Groups:
This trial has the following groups:- Group 1: COT-Based Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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