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

NCT ID: NCT04902014

Last Updated: 2023-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-13

Study Completion Date

2020-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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.

Motivational Interviewing

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Wearable Fitness Tracker

Group Type EXPERIMENTAL

Wearable Fitness Trackers

Intervention Type BEHAVIORAL

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+

Group Type EXPERIMENTAL

Wearable Fitness Tracker+

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colorado State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Performance Clinical Research Laboratory

Fort Collins, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19-9439H

Identifier Type: -

Identifier Source: org_study_id

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