Clinical trial NCT04902014: A Study to Test the Effectiveness of Different Interventions to Improve Physical Activity in Adults.
Official title: The Combined Effect OF Motivational Interviewing and Wearable Fitness Trackers on Motivation and Physical Activity In Inactive Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: mHealth
physical activity
motivation
self-determination theory
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Motivation From Baseline at 12 Weeks.
timeFrame: Baseline and at 12 weeks.
measure: Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks.
timeFrame: Baseline and at 12 weeks
measure: Change in Steps Per Day From Baseline at 12 Weeks.
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Human Performance Clinical Research Laboratory
state: Colorado
Study officials:
References: