CompletedNot Applicable

A Study to Test the Effectiveness of Different Interventions to Improve Physical Activity in Adults.

United States40 participantsStarted 2020-04-13

Plain-language summary

During the initial months of the COVID-19 pandemic, physical activity (PA) engagement levels declined worldwide. Despite the overwhelming adoption of wearable fitness tracker (WFT) devices, it continues to be unclear as to their effect on PA engagement or PA motivation. Building on past research, we hypothesized that combining a WFT with a known impactful intervention, motivational interviewing (MI) would positively influence both self-determination theory (SDT) motivation and PA during an unprecedented global emergency. A four-group randomized controlled study was conducted amongst 40 inactive adults over a 12-week period during the COVID-19 pandemic. One group (WFT, n = 10) received a wearable fitness tracker, a second (MI, n=10) received bi-weekly MI sessions, a third (WFT+, n=10) received both, and a fourth (Education, n=10) received basic PA education. Outcome measures for motivation and PA were measured though an online survey before and after the 12-week period.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Females or males, aged 18 or older, * does not currently engage in 150 minutes of moderate to vigorous PA per week, * owns an Android, or iPhone smartphone device, * is willing to download a mobile app to be used on the smartphone device, 5) is willing to wear a small, wrist worn fitness tracker for the duration of the study, and 6) is be willing to attend 6 biweekly MI sessions over 12 weeks. Exclusion Criteria: * a history of myocardial infarction, angina, coronary artery bypass surgery, congestive heart failure, or diabetes, * limiting conditions such as concurrent cancer treatment, peripheral artery disease, orthopedic injury, or pain limiting arthritis, * seeking to participate in other structured PA programs during the duration of the study, * pregnant at the initiation of the study or plans to become pregnant during the study, and * alcohol or other substance abuse within the previous 12 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Motivation From Baseline at 12 Weeks.

Timeframe: Baseline and at 12 weeks.

Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks.

Timeframe: Baseline and at 12 weeks

Change in Steps Per Day From Baseline at 12 Weeks.

Timeframe: Baseline and at 12 weeks

Trial details

NCT IDNCT04902014

SponsorColorado State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-21

Results submitted2021-08-16

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