Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis

NCT ID: NCT05641532

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-08-08

Brief Summary

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.

Conditions

Multiple Sclerosis (MS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention

This is a 1-arm study with an intervention condition based on the COM-B model

Group Type: EXPERIMENTAL

Physical activity behavioral intervention in persons newly diagnosed with MS

Intervention Type: BEHAVIORAL

1. The newsletters will provide the knowledge, skills, resources, and strategies for promoting physical activity in persons newly diagnosed with MS. These newsletters will be released seven times during the program. The first three newsletters will be released weekly, and the last four will be released every other week.

2. The one-on-one video coaching chats with participants will be conducted via Zoom, which consist of discussion and elaboration of newsletters content, supportive accountability, feedback and encouragement on behavior change. The chats further provide social persuasion for promoting behavior change. The chats are semi-scripted and individualized interventions (~15 - 30 minutes/chat). The chats will occur seven times during the week when a newsletter is delivered.

3. The intervention includes a pedometer (NL-800 pedometer), a logbook, and a calendar for tracking daily step counts, planning of physical activity, setting goals, and monitoring progress over the program.

Interventions

Physical activity behavioral intervention in persons newly diagnosed with MS

1. The newsletters will provide the knowledge, skills, resources, and strategies for promoting physical activity in persons newly diagnosed with MS. These newsletters will be released seven times during the program. The first three newsletters will be released weekly, and the last four will be released every other week.

2. The one-on-one video coaching chats with participants will be conducted via Zoom, which consist of discussion and elaboration of newsletters content, supportive accountability, feedback and encouragement on behavior change. The chats further provide social persuasion for promoting behavior change. The chats are semi-scripted and individualized interventions (~15 - 30 minutes/chat). The chats will occur seven times during the week when a newsletter is delivered.

3. The intervention includes a pedometer (NL-800 pedometer), a logbook, and a calendar for tracking daily step counts, planning of physical activity, setting goals, and monitoring progress over the program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 18 years old
• Diagnosed with multiple sclerosis for 2 or fewer years
• Fully ambulatory
• No relapse within the last 30 days
• Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score < 14)
• Able to read 14-point font size
• Internet & video conferencing access
• Undergoing disease-modifying therapy

Exclusion Criteria

• Pregnancy
• Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Barstow

Faculty Advisor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300009893

Identifier Type: -

Identifier Source: org_study_id