HealthyNCT04902014

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

A study testing Motivational Interviewing, Education and Wearable Fitness Trackers in people with Healthy, run by Colorado State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Motivational Interviewing, Education and Wearable Fitness Trackers
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 13 Apr 2020to 21 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Human Performance Clinical Research Laboratory
Fort Collins, Colorado, 80521

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About this study

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

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.

Conditions: Healthy
Being tested: Motivational Interviewing, Education, Wearable Fitness Trackers, Wearable Fitness Tracker+
Keywords: mHealth, physical activity, motivation, self-determination theory
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motivational InterviewingBehavioural
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.
EducationBehavioural
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 TrackersBehavioural
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+Behavioural
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.

Study groups in NCT04902014
Study group	Role	What they receive
Education	Active comparator	Not described Receives: Behavioral: Education
Motivational Interviewing	Experimental	Not described Receives: Behavioral: Motivational Interviewing
Wearable Fitness Tracker	Experimental	Not described Receives: Behavioral: Wearable Fitness Trackers
Wearable Fitness Tracker+	Experimental	Not described Receives: Behavioral: Wearable Fitness Tracker+

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and at 12 weeks.
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).
Measured: Baseline and at 12 weeks
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).
Measured: Baseline and at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202021 Sep 2020

First posted26 May 2021
Study start13 Apr 2020
Primary completion21 Sep 2020
Study completion21 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04902014
Sponsor's protocol ID: 19-9439H
Status last verified: Sep 2022
First submitted: 9 May 2021
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Combined Effect OF Motivational Interviewing and Wearable Fitness Trackers on Motivation and Physical Activity In Inactive Adults: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04902014
Acronym / sponsor ID: 19-9439H
Conditions: Healthy
Keywords: mHealth, physical activity, motivation, self-determination theory
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Colorado State UniversityUniversity, hospital or other
Study start: 13 Apr 2020 (actual)
Primary completion: 21 Sep 2020 (actual)
Study completion: 21 Sep 2020 (actual)
First posted: 26 May 2021 (actual)
Results: Posted 27 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Education	Active comparator	Behavioral: Education
Motivational Interviewing	Experimental	Behavioral: Motivational Interviewing
Wearable Fitness Tracker	Experimental	Behavioral: Wearable Fitness Trackers
Wearable Fitness Tracker+	Experimental	Behavioral: Wearable Fitness Tracker+

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Motivational InterviewingThe 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.	Behavioural	Motivational Interviewing
EducationThese 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.	Behavioural	Education
Wearable Fitness TrackersIndividuals 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.	Behavioural	Wearable Fitness Tracker
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.	Behavioural	Wearable Fitness Tracker+

Primary outcome

Change in Motivation From Baseline at 12 Weeks.
Time frame: Baseline and 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.
Change in Moderate to Vigorous Physical Activity From Baseline at 12 Weeks.
Time frame: Baseline and at 12 weeks
Moderate to Vigorous Physical Activity (MVPA) was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).
Change in Steps Per Day From Baseline at 12 Weeks.
Time frame: Baseline and at 12 weeks
Steps per day was assessed using five days (4 weekdays and 1 weekend day) of actigraphy (ActiGraph).

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Education	10	10
Motivational Interviewing	10	10
Wearable Fitness Tracker	10	10
Wearable Fitness Tracker+	10	10

Primary outcome: Change in Motivation From Baseline at 12 Weeks.

Time frame: Baseline and at 12 weeks.. Mean (Standard Deviation). Unit: Units on a scale

Measure	Education n = 10	Motivational Interviewing n = 10	Wearable Fitness Tracker n = 10	Wearable Fitness Tracker+ n = 10
Amotivation	0.30 (0.40)	0.48 (0.43)	0.40 (0.36)	0.43 (0.49)
External Regulation	1.58 (1.25)	1.45 (0.91)	0.89 (0.40)	1.27 (0.73)
Introjected Regulation	2.45 (1.02)	2.33 (0.82)	2.31 (0.77)	2.48 (0.63)
Identified Regulation	3.10 (0.47)	3.10 (0.53)	3.20 (0.75)	3.33 (0.54)
Integrated Regulation	2.38 (0.93)	2.45 (0.47)	2.61 (0.81)	2.63 (0.83)
Intrinsic Motivation	2.47 (0.53)	2.70 (0.62)	2.87 (0.80)	2.98 (0.59)
Relative Autonomy Index	3.37 (2.59)	4.00 (2.06)	5.08 (2.27)	4.78 (2.22)
Autonomy	3.62 (0.72)	3.97 (0.43)	4.10 (0.45)	4.23 (0.35)

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

Time frame: Baseline and at 12 weeks. Mean (Standard Deviation). Unit: Minutes of MVPA per day

Measure	Education n = 10	Motivational Interviewing n = 10	Wearable Fitness Tracker n = 10	Wearable Fitness Tracker+ n = 10
Minutes of Moderate to Vigorous Physical Activity per Day	66.70 (17.83)	67.75 (16.47)	76.37 (29.19)	71.08 (36.90)
Minutes of Moderate to Vigorous Physical Activity per Weekday	66.17 (16.99)	64.00 (25.10)	78.97 (32.67)	68.60 (41.11)
Minutes of Moderate to Vigorous Activity per Weekend Day	72.32 (29.27)	69.70 (22.30)	66.17 (38.62)	76.38 (38.50)

Primary outcome: Change in Steps Per Day From Baseline at 12 Weeks.

Time frame: Baseline and at 12 weeks. Mean (Standard Deviation). Unit: Steps per day

Measure	Education n = 10	Motivational Interviewing n = 10	Wearable Fitness Tracker n = 10	Wearable Fitness Tracker+ n = 10
Steps per Day	6155.58 (1370.35)	5400.56 (1314.90)	6693.01 (2394.24)	6232.15 (2857.27)
Steps per Weekday	6216.31 (1370.35)	5211.16 (1847.80)	7183.81 (2430.83)	6123.24 (3047.30)
Steps per Weekend Day	6387.75 (2350.78)	5235.22 (1749.21)	5275.90 (3292.88)	6565.06 (3156.44)

Adverse events

Time frame: Twelve weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Education	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Motivational Interviewing	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Wearable Fitness Tracker	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Wearable Fitness Tracker+	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Conducted the study during the COVID-19 pandemic. Homogenous sample. Did not assess wear time or compliance with wear directives in WFT and WFT+ groups. RAI does not allow for an investigation into the more nuanced and multidimensional aspects of SDT motivation as it pertains to PA.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing, Education and Wearable Fitness Trackers in people with Healthy, run by Colorado State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Motivation From Baseline at 12 Weeks. (time frame: Baseline and at 12 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04902014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.