- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05216393
A Person-Centered Geotagged Social Networking System to Promote Physical Activity in the Community (RECTECHIV)
RecTech Match Feasibility Testing (RERC on Exercise and Recreational Technologies for People With Disabilities- RECTECH IV)
The multilevel socio-ecological barriers to physical activity experienced by people with physical disabilities cut across structures and systems, community, institutions and organizations, interpersonal, and individual levels. Several studies have attempted to understand these barriers and facilitators, but to date, no study or system has attempted to systematically resolve these multilevel barriers and capitalize on the potential facilitators that can increase access to exercise and recreation programs, services and facilities for people with disabilities.
In RecTech's previous cycle of funding, this void was addressed in a Proof of Concept product called the Activity Inclusion Mapping System (AIMS). AIMS enabled people with disabilities to quickly and precisely identify accessible and usable community-based physical activity resources and services. Based on the positive feedback received at the annual RESNA conference and from our Consumer Research Advisory Committee (CRAC) during preparation of this application, the investigators propose to develop an innovative person-centered geotagged Social Networking System (SNS) based on the social-ecological model of health.
The focus of this proposed Proof of Product project is to address multilevel barriers and facilitators associated with community-based leisure time physical activity (LTPA) using crowdsourcing principles for gathering data. The project is targeted to all people with physical disabilities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The stage of development for a RecTech Match website is a Proof of Product. The RecTech Match website will be a new online resource that will provide physical activity resources inclusive of people with disabilities. Users will be able to search for accessible opportunities for physical activity near them, watch videos on-demand related to exercise, and read articles to learn about exercise or introduce them to new community exercise opportunities. Once successful feasibility testing is completed, the investigators will work with nchpad.org, to seed information and launch nationally.
Thirty users with physical disabilities, ages 18 to 64, will participate in a 12-wk two-arm parallel randomized control trial (15 per group) aimed at reducing barriers to physical activity, increasing social support and increasing leisure-time physical activity minutes. A sample of 15 per arm will be sufficient for our pilot/feasibility study. The control arm will have access to generic information available on the National Center on Health Physical Activity and Disability (NCHPAD) website, which includes the same information but is not delivered through RecTechMatch.com. All users will be recruited online. Fitbit sensors will be provided to participants to objectively measure physical activity minutes Process feasibility outcome measures will include recruitment, retention and adherence, and Intervention efficacy outcomes will include the Godin-Shephard Leisure-Time Physical Activity Questionnaire, the Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI), and Chogahara's Social Influence on Physical Activity questionnaire. Daily self-report physical activity will be collected by secure email or text. Health Coaching calls and exit interviews will be recorded via Twilio Flex.
After baseline assessments are completed by all participants, each will be randomized to the 2 study arms in a 1:1 Each participant will be randomly assigned (through REDCap) to 1 of 2 treatment conditions: (1) RecTech match intervention with tele-coaching support, and (2) control. All participants will receive a welcome call and asked to provide days and times that are most convenient to attend tele-health coaching calls. Intervention group participants will receive an orientation call once shipment is received of the Fitbit device to help set the device up and ready for data collection.
The intervention group will be mailed a Fitbit device and provided access to the RecTech Match website. These participants will receive weekly calls for the first 6 weeks, and a call every other week for the following 6 weeks (9 in total) from a health coach to discuss intervention progress, facilitate setting physical activity goals, and help mitigate obstacles to participate in physical activity in the community. Participants will be free to access the features and resources of the website. The Fitbit data will be collected on an ongoing basis and the participants will receive daily texts asking them to rate the amount of physical activity for the day.
The control participants will not have access to the RecTech Match website; however, control participants will be directed to generic information available on the NCHPAD website, which includes the same information but is not delivered through RecTechMatch.com.
All participants will receive survey packets through RedCap's auto-delivery system. Survey packets will be delivered at 12 and 24 weeks. Additionally, Intervention participants will participate in a short exit interview.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- Recruiting
- UAB / Lakeshore Research Collaborative
-
Contact:
- Christen J Mendonca, PhD
- Phone Number: 205-975-6415
- Email: christenjm@uab.edu
-
Principal Investigator:
- Mohanraj Thirumalai, PhD
-
Sub-Investigator:
- Christen J Mendonca, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 64 years old
- self-reported physical disability that limits their mobility
Exclusion Criteria:
- Cognitive or linguistic problems with understanding instructions or filling in self-administered outcome measures
- Cardiovascular disease event within the past 6 months
- Severe pulmonary disease or renal failure
- Currently pregnant
- Ongoing exacerbation of a health condition
- Other conditions that would interfere with being physically active
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
The intervention group will be mailed a Fitbit device and provided access to the RecTech Match website.
Intervention participants will receive weekly calls for the first 6 weeks, and a call every other week for the following 6 weeks (9 in total) from a health coach to discuss progress, facilitate setting physical activity goals, and help mitigate obstacles to participate in physical activity in the community.
Participants will be free to access the features and resources of the website.
The Fitbit data will be collected on an ongoing basis and the participants will receive daily texts asking them to rate the amount of physical activity for the day.
|
Participants will have access to the Rectech Match website.
These participants will receive 9 health coaching calls.
Fitbit physical activity data will be collected on an ongoing basis during the intervention.
Other Names:
|
No Intervention: Control
The control participants will not have access to the RecTech Match website; however, control participants will be directed to generic information available on the NCHPAD website, which includes the same information but is not delivered through RecTechMatch.com.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Godin - Leisure time physical activity questionnaire
Time Frame: pre-intervention and again at the end of 12 weeks
|
Estimates habitual leisure time physical activity.
Higher numbers indicate more times the person has engaged in physical activity separated by 3 categories.
There is no scoring limit.
|
pre-intervention and again at the end of 12 weeks
|
Barriers to Physical Activity Questionnaire for People with Mobility Impairments
Time Frame: pre-intervention and again at the end of 12 weeks
|
Identifies barriers to physical activity, specifically designed for individuals with a mobility.
impairment.
The survey has 8 subscales (health, beliefs and attitudes, family, friends, fitness-center-built environment, staff and policy, community built environment, and safety.
Subscale scores of 1 to 5 are calculated.
Higher values indicate a higher influence of barriers.
|
pre-intervention and again at the end of 12 weeks
|
Chogahara's Social Influence on Physical Activity Questionnaire
Time Frame: pre-intervention and again at the end of 12 weeks
|
Measures a persons perceptions on how their physical activity is affected by social influences.
The survey has 3 factors (friends, family, and health/fitness expert) and 3 subscales (companionship, informational, and emotional support).
Each subscale can have a minimum maximum score of 4 with a higher score indicating a higher frequency of influence.
|
pre-intervention and again at the end of 12 weeks
|
Post Intervention Interviews
Time Frame: pre-intervention and again at the end of 12 weeks
|
Gather feedback on the end user's experiences using the website.
|
pre-intervention and again at the end of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FitBit device data (total energy expenditure, steps, sedentary time, light activity time, moderate activity time, high activity time, and activity energy expenditure).
Time Frame: FitBit Data will be continuously collected for 12 weeks
|
The Fitbit device reports, the total amount of energy expended (kCal) per day, the number of steps achieved per day, the number of minutes that the wearer engaged either sedentary activity or physical activity (light, moderate, high), and finally the energy expenditure cost of the physical activity (kCAL) per day.
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FitBit Data will be continuously collected for 12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Takacs J, Pollock CL, Guenther JR, Bahar M, Napier C, Hunt MA. Validation of the Fitbit One activity monitor device during treadmill walking. J Sci Med Sport. 2014 Sep;17(5):496-500. doi: 10.1016/j.jsams.2013.10.241. Epub 2013 Oct 31.
- Amireault S, Godin G. The Godin-Shephard leisure-time physical activity questionnaire: validity evidence supporting its use for classifying healthy adults into active and insufficiently active categories. Percept Mot Skills. 2015 Apr;120(2):604-22. doi: 10.2466/03.27.PMS.120v19x7. Epub 2015 Mar 23.
- Martin Ginis KA, Ma JK, Latimer-Cheung AE, Rimmer JH. A systematic review of review articles addressing factors related to physical activity participation among children and adults with physical disabilities. Health Psychol Rev. 2016 Dec;10(4):478-494. doi: 10.1080/17437199.2016.1198240. Epub 2016 Jun 29.
- Vasudevan V, Rimmer JH, Kviz F. Development of the Barriers to Physical Activity Questionnaire for People with Mobility Impairments. Disabil Health J. 2015 Oct;8(4):547-56. doi: 10.1016/j.dhjo.2015.04.007. Epub 2015 May 14.
- McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401.
- Chogahara M. A multidimensional scale for assessing positive and negative social influences on physical activity in older adults. J Gerontol B Psychol Sci Soc Sci. 1999 Nov;54(6):S356-67. doi: 10.1093/geronb/54b.6.s356.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 300007761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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