Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207084
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-01-05
Brief Title:
The Fit with Us Study
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Precision-based Teleexercise Trial to Increase Adherence in People with Disabilities
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FITWITHUS
Brief Summary:
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 another 8 weeks After final surveys participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data
The study outcomes are
The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics
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 another 8 weeks After final surveys participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data
The study outcomes are
The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics
Detailed 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 Additionally during the run-in period the research team will ship an exercise tracker device and a set of wrist weights 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
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 8 health coaching calls
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
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 an 8-week Maintenance phase weeks 9 to 16 Upon completion of week 16 the participant will complete a final survey packet Participants will receive access to the website and content for another 16 weeks and complete a final survey packet Throughout the study we will be collecting data from the participants exercise tracker These data include steps and minutes of activityinactivity During weeks 16 to 32 Participants will have open access to the website and is 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 4th week or 8 week surveys see attached call outline
This intervention will be administered in waves of about 33 to 34 participants The first wave will be a pilot wave The data generated from this pilot wave will not be included in the final analyses but serve as a test for the intervention Additionally pilot wave participants will be asked to complete semi-strucutred interview at the end of both week 8 and week 16
After completion of the pilot wave the research team may modify or refine the intervention and submit an amendment to the IRB After approval is obtained the remaining intervention waves will proceed See attached Pilot Wave Consent
We will use the following validated measures
Surveys see attached
Demographic and Health History Questionnaire baseline
Godin Leisure Time Exercise Questionnaire GLTEQ
Patient Reported Outcomes Measurement Information System Short-Form Fatigue PROMIS SF-F
Social Cognitive Theory Social Provisions Scale SPS
Barriers to Self-Efficacy Scale for Physical Activity BARSE-PA
eHealth Literacy Scale eHEALS
36-Item Short Form Survey physical functioning SF36 PF
mHealth Application Usability Questionnaire MAUQ
Acceptability of Intervention Appropriateness Measure Intervention Appropriateness Measure amp Feasibility of Intervention Measure
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 Additionally during the run-in period the research team will ship an exercise tracker device and a set of wrist weights 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
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 8 health coaching calls
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
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 an 8-week Maintenance phase weeks 9 to 16 Upon completion of week 16 the participant will complete a final survey packet Participants will receive access to the website and content for another 16 weeks and complete a final survey packet Throughout the study we will be collecting data from the participants exercise tracker These data include steps and minutes of activityinactivity During weeks 16 to 32 Participants will have open access to the website and is 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 4th week or 8 week surveys see attached call outline
This intervention will be administered in waves of about 33 to 34 participants The first wave will be a pilot wave The data generated from this pilot wave will not be included in the final analyses but serve as a test for the intervention Additionally pilot wave participants will be asked to complete semi-strucutred interview at the end of both week 8 and week 16
After completion of the pilot wave the research team may modify or refine the intervention and submit an amendment to the IRB After approval is obtained the remaining intervention waves will proceed See attached Pilot Wave Consent
We will use the following validated measures
Surveys see attached
Demographic and Health History Questionnaire baseline
Godin Leisure Time Exercise Questionnaire GLTEQ
Patient Reported Outcomes Measurement Information System Short-Form Fatigue PROMIS SF-F
Social Cognitive Theory Social Provisions Scale SPS
Barriers to Self-Efficacy Scale for Physical Activity BARSE-PA
eHealth Literacy Scale eHEALS
36-Item Short Form Survey physical functioning SF36 PF
mHealth Application Usability Questionnaire MAUQ
Acceptability of Intervention Appropriateness Measure Intervention Appropriateness Measure amp Feasibility of Intervention Measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 90REGE0019 | OTHER_GRANT | National Institute on Disability Independent Living and Rehabilitation Research | None |