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

September 9, 2022 updated by: Colorado State University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80521
        • Human Performance Clinical Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motivational Interviewing
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.
Active Comparator: Education
Behavioral: 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.
Experimental: Wearable Fitness Tracker
Behavioral: 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.
Experimental: Wearable Fitness Tracker+
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and at 12 weeks.
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).
Baseline and at 12 weeks
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).
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-9439H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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