Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention | Experimental | This is a 1-arm study with an intervention condition based on the COM-B model |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity behavioral intervention in persons newly diagnosed with MS | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility metric: Process | Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures | 12 weeks |
| Feasibility metric: Resource | We will assess the resources required for the study. | 12 weeks |
| Feasibility metric: Management | Management assesses data management. | 12 weeks |
| Feasibility metric: Overall safety | Overall safety will be assessed through the number of adverse events. | 12 weeks |
| Change of Physical Activity levels through Accelerometry from baseline and 12 weeks | Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline and 12 weeks | 12 weeks |
| Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks | Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks. | 12 weeks |
| Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks | Self report measures of fatigue will be assessed through the Fatigue Severity Scale. Participants will complete this questionnaire at baseline and 12 weeks | 12 weeks |
| Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
All participants will undergo one intervention condition remotely delivered using electronic newsletters and one-on-one video coaching. Outcome measures will be assessed at two time points: baseline and post-intervention.
Not provided
Not provided
Not provided
Not provided
|
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
| 12 weeks |
Self report measures of quality of life will be assessed through the Multiple Sclerosis Impact Scale-29.Participants will complete this questionnaire at baseline and 12 weeks |
| 12 weeks |
| Formative evaluation | Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week. | 12 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |