Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
257 participants
INTERVENTIONAL
2024-09-01
2029-02-01
Brief Summary
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Detailed Description
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During the run-In period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, Participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. (see attached call outline)
After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks.
The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks.
The proposed Sequential Multiple Assignment Randomized Trial (SMART) study seeks to develop an effective 32-week, resource-sensitive strategy to improve physical activity levels in people with mobility impairments. During the run-in period before the start of the intervention, interested individuals will consent to be part of the study. Once providing consent, participants will respond to a baseline survey packet through REDCap. Participants must also complete a welcome call and set up an online account. Additionally, during the run-in period, the research team will ship an exercise tracker device, and an exercise band for the participant to wear during the intervention. The participant will receive an orientation call to assist them with using the website, setting up their exercise tracking device, and linking the device to the website. After the run-in period, participants will be randomized into 1 of 2 groups: Asynchronous Exercise Program (AEP) and AEP + Smart Health Coaching (SHC). Finally, participants will be given access to the FitWithUs online platform, hosted on UAB servers, to access all the exercise content (exercise videos and articles). All participants will receive at least one new health and wellness article per week for eight weeks, and new exercise videos for 16 weeks. This intervention will be administered in 8 waves of \~33-34 participants each (pilot wave data excluded from analyses). The Adoption Phase will be split into two 4-week phases: early adoption (weeks 1 to 4) and late adoption (weeks 5 to 8). Participants in both groups will engage in pre-recorded exercise content. The AEP + SHC group may receive up to 12 health coaching calls. Machine learning will be used in Weeks 2, 6, and 10 to predict which AEP + HC participants should receive coaching calls for the next four weeks. At the end of the early adoption phase, the participant will complete a short set of questions (See week 4 questionnaire) the research team will classify participants in both groups into either a responder or a non-responder. If a participant is a responder, they will continue with their group assignment through the late adoption phase (AEP only or AEP + SHC). If the participant is a non-responder, they will be randomized a second time into 1 of 2 sub-groups: Live 1-on-1 training or Live group training for the late adoption phase. All live training will occur remotely through ZOOM. Participants in non-responder sub-groups will be asked to participate in their respective live training up to 3 times per week for weeks 5 to 8. This second randomization results in six possible intervention groups: 1) AEP only responder, 2) AEP + HC responder, 3) AEP non-responder + LAT\_1-1, 4) AEP non-responder + LAT\_GRP, 5) AEP + HC non-responder + LAT\_1-1, 6) AEP + HC non-responder + LAT\_GRP. Upon finishing the late adoption phase, all participants will complete another survey packet and a semi-structured interview (see interview guide), and receive AEP only for a 24-week maintenance phase (weeks 9-32). Upon completion of week 32, the participant will complete a final survey packet. Throughout the study, we will be collecting data from the participant's exercise tracker. These data include steps and minutes of activity/inactivity. During weeks 9 to 32, participants will have open access to the website and its library of exercise content. The research team will continue to collect activity data and website analytics (for example video watch minutes). Participants may receive a reminder call to complete surveys. We will use the following validated measures: \[existing measures list unchanged\].
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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asynchronous exercise responder
Individuals only receiving asynchronous exercise content and are responding
asynchronous content only
Receives asynchronous exercise content and no live training
Asynchronous exercise and health coaching responder
Individuals receiving asynchronous exercise content and health coaching and are responding
Asynchronous content and health coaching and no live training
Receives asynchronous content, health coaching and no live training.
Asynchronous exercise non-responder and 1 on 1 live training
Individuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions.
asynchronous content only and 1 on 1 live training
receives asynchronous content and live 1 on 1 training
Asynchronous exercise and health coaching non-responder and 1 on 1 live training
Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions.
asynchronous content and health coaching and 1 on 1 training
receives asynchronous content, health coaching, and live training
Asynchronous exercise non-responder and group live training
Individuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions.
asynchronous content and group training
receives asynchronous content and live group training
Asynchronous exercise and health coaching non-responder and group live training
Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions.
Asynchronous content and health coaching and group training
receives asynchronous content, health coaching, and live group training
Interventions
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asynchronous content only
Receives asynchronous exercise content and no live training
Asynchronous content and health coaching and no live training
Receives asynchronous content, health coaching and no live training.
asynchronous content only and 1 on 1 live training
receives asynchronous content and live 1 on 1 training
asynchronous content and health coaching and 1 on 1 training
receives asynchronous content, health coaching, and live training
asynchronous content and group training
receives asynchronous content and live group training
Asynchronous content and health coaching and group training
receives asynchronous content, health coaching, and live group training
Eligibility Criteria
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Inclusion Criteria
18 Years
89 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Mohanraj Thirumalai
Associate Professor
Principal Investigators
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Mohanraj Thirumalai, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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Wellness, Health and Research Facility
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Intervention landing page.
Other Identifiers
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90REGE0019
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300011762
Identifier Type: -
Identifier Source: org_study_id
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