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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Active Comparator |
| |
| Motivational Interviewing | Experimental |
| |
| Wearable Fitness Tracker | Experimental |
| |
| Wearable Fitness Tracker+ | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Performance Clinical Research Laboratory | Fort Collins | Colorado | 80521 | United States |
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Consented participants were stratified by sex (male/female) and age (20-29, 30-39, 40-49, 50-59, and 60-69 y/o.) before being randomized to one of four conditions.
Participants were recruited through a variety of means including flyers on the Colorado State University campus, social media, and mass emails. Participants were recruited and admitted into the study on a rolling basis from April 2020-June 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Education | 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. |
| FG001 | Motivational Interviewing | 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. |
| FG002 | Wearable Fitness Tracker | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Education | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and at 12 weeks. |
|
Twelve weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Education | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kayla Nuss | Colorado State University | 9705814824 | kayla.nuss@colostate.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2022 | Sep 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2021 | Aug 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Education | 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. |
|
| Wearable Fitness Trackers | 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+ | 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. |
|
| BG001 | Motivational Interviewing | 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. |
| BG002 | Wearable Fitness Tracker | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Motivation Variables | The Behavioral Regulations in Exercise Scale version 3, (BREQ-3) was used to collect pre- and post- motivation for exercise variables including Amotivation, External, Introjected, Identified, and Integrated Regulation, and Intrinsic Motivation. The scale is on a 0 (does not apply to me) to 4 (applies to me very much) scale. The Basic Psychological Needs in Exercise Scale was used to collect pre- and post- autonomy, competence, and relatedness. The scale is on a 0 (does not apply to me) to 4 (applies to me very much) scale. | Mean | Standard Deviation | units on a scale |
|
| Physical Activity Variables | Mean | Standard Deviation | units on a scale |
|
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.
| OG001 | Motivational Interviewing | 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. |
| OG002 | Wearable Fitness Tracker | 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. |
| OG003 | 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. |
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| 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). | Posted | Mean | Standard Deviation | Minutes of MVPA per day | Baseline and at 12 weeks |
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| 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). | Posted | Mean | Standard Deviation | Steps per day | Baseline and at 12 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Motivational Interviewing | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Wearable Fitness Tracker | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| Minutes of Moderate to Vigorous Physical Activity per Weekday |
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| Minutes of Moderate to Vigorous Activity per Weekend Day |
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| Steps per Weekday |
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| Steps per Weekend Day |
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