The Fit With Us Study (FITWITHUS)
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Details and patient eligibility
About
The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.
Full description
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. (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].
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Inclusion and exclusion criteria
Eligible participants must meet the following criteria to be included: (1) live with a permanent physical disability that limits their mobility; (2) be 18 to 89 years of age; (3) have broadband internet access; (4) be able to speak and read English; and (5) be able to attend coaching and training sessions during the weekdays.
Participants are excluded from participation if they (1) possess significant visual acuity that prevents seeing a computer screen to follow a home exercise program; (2) have been regularly engaging in exercise for the previous 3 months; (3) are unable to use their arms and their legs at all to exercise; (4) are unsafe to exercise; (5) self-report that they are currently pregnant
Trial design
Primary purpose
Allocation
Interventional model
Masking
257 participants in 6 patient groups
Trial contacts and locations
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Central trial contact
Sangeetha Mohanraj, MS; Mohanraj Thirumalai, PhD
Data sourced from clinicaltrials.gov
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