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

Healthy Clinical Trial

Official title:

The Combined Effect OF Motivational Interviewing and Wearable Fitness Trackers on Motivation and Physical Activity In Inactive Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902014
• Other study ID #: 19-9439H
• Status: Completed
• Phase: N/A
• Start date: April 13, 2020
• Est. completion date: September 21, 2020

Study information

• Verified date: September 2022
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Motivational Interviewing
The individuals will be scheduled for and participate in six biweekly in person SDT based MI sessions. These sessions will take place in the HPCRL at CSU. The MI sessions will be conducted by a PhD student who has been trained by a MI practitioner. Participants will be provided a log book and will be asked to log their PA, with the goal of completing at least 150 minutes of PA per week. They will set biweekly PA goals, which will be discussed in the MI sessions. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.
• Education
These participants will receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting. These participants will not do any other study related activities. At the conclusion of the study, these participants will be offered the chance to participate in one MI session.
• Wearable Fitness Trackers
Individuals assigned to this experimental condition will be given a wrist-worn WFT and will be instructed to wear it for the duration of the study. They will also download the corresponding mobile application on their smartphones. They will be trained by a member of our team on how to utilize the WFT and mobile application. The intended WFT tracks daily steps, miles traveled, kcals expended, and daily activity time. This device provides these data to the wearer via a small screen. Participants will be instructed to aim to complete at least 150 minutes of PA per week. Researchers will have the capability to track participant daily PA via the WFT and associated API. These individuals will be asked to set biweekly PA goals. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.
• Wearable Fitness Tracker+
These individuals will be given the wrist-worn WFT, be instructed to wear it for the duration of the study AND be scheduled for six SDT based MI sessions. These participants will also be trained by a member of our team on how to utilize the WFT and associated application. They will be instructed to aim to complete 150 minutes of PA per week. These participants will be asked to set biweekly PA goals which will be discussed in MI sessions. Researchers will have the capability to track participant daily PA via the WFT and associated API. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.

Locations

Country	Name	City	State
United States	Human Performance Clinical Research Laboratory	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motivation From Baseline at 12 Weeks.	Changes in motivation for physical activity as described by the self-determination theory was assessed using the Behavioral Regulation in Exercise Questionnaire, v3 (BREQ-3) and the Basic Psychological Needs in Exercise Scale (BPNS). The BREQ-3 uses four survey items per motivational subtype (Amotivation, External, Introjected, Identified, and Integrated Regulation, and Intrinsic Motivation). The BPNS uses three of four items per psychological need (Autonomy, Competence, and Relatedness) The raw scores per subtype or need are averaged for one subtype and need score per participant. The scale ranges from 0 (does not apply to me) to 4 (applies to me very much). Therefore, subtype or need score closer to ) indicate low levels of that subtype whereas scores closer to 4 indicate higher levels of that subtype or need.	Baseline and at 12 weeks.
Primary	Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks.	Moderate to Vigorous Physical Activity (MVPA) was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).	Baseline and at 12 weeks
Primary	Change in Steps Per Day From Baseline at 12 Weeks.	Steps per day was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).	Baseline and at 12 weeks