Physical Activity Intervention for Individuals Newly Diagnosed With MS

NCT07731659 | Not Yet Recruiting

• 1 other identifier: STUDY2026-0787
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a parallel-group randomized controlled trial (RCT) designed to establish the behavioral mechanism underlying a 16-week physical activity (PA) behavioral intervention through its effects on the Capability-Opportunity-Motivation-Behavior (COM-B) constructs. The success of this study will provide robust evidence for supporting its refinement via refined COM-B constructs and Behavior Change Techniques to facilitate or maximize the intervention effects on PA levels, which will be examined in the subsequent clinical trial. Such an approach will involve an RCT that examines the effects of a 16-week remotely delivered, Internet-based PA behavioral intervention via video behavioral coaching and newsletter compared with a waitlist control (WLC) condition for yielding improvements in the COM-B constructs among persons newly diagnosed with multiple sclerosis (PNDwMS, disease duration ≤ 2 years). The investigators hypothesize that participants in the PA behavioral intervention condition will demonstrate greater improvements in the COM-B constructs than those in the WLC condition. The investigators plan to recruit 50 PNDwMS, with a distribution of 25 participants in the PA behavioral intervention and 25 participants in the WLC condition. The primary outcomes are the self-report COM-B constructs (listed in the Outcomes section), which will be remotely assessed at baseline and post-intervention through an online battery of questionnaires via REDCap. Specific Aim 1: to establish mechanisms for the behavior change intervention using a 2-arm pilot randomized controlled trial (RCT) of the intervention compared with the waitlist control (WLC) among PNDwMS. The investigators hypothesize that the 16-week COM-B-based behavioral intervention delivered by one-on-one behavior coaching and newsletters will result in larger changes in COM-B constructs (i.e., knowledge, outcome expectations, goal, intention, behavioral regulation, self-efficacy, fatigue, social support, and social and environmental barriers) than in the WLC group. Specific Aim 2: to examine change in self-reported physical activity levels in PNDwMS who received the COM-B-based intervention compared with those who are in the waitlist control condition. The investigators hypothesize that the 16-week COM-B-based behavioral intervention will result in larger changes in self-reported physical activity outcomes than in the WLC group.

Conditions

Multiple Sclerosis

Keywords

Physical Activity; Newly Diagnosed MS; Behavioral Intervention

Outcome Measures

Primary Outcomes (10)

• Knowledge and Information Provision Questionnaire (NIP)

  The Knowledge and Information Provision questionnaire will be administered remotely for self-report assessment of knowledge about physical activity. 3 items; Likert scale 1 - 4 (No - Yes, comprehensively)

  Baseline and week 16

• Multidimensional Outcome Expectations for Exercise Scale (MOEES)

  The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity/exercise. 15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree)

  Baseline and week 16

• Behavioral Intention

  The behavioral intention will be administered remotely for physical activity behavioral intentions. 5 items; Likert scale 1- 4 (Not true - Completely true)

  Baseline and week 16

• Exercise Goal Setting Scale (EGS)

  The EGS will be administered remotely to capture goal-setting skills. It includes 10 items rates on a Likert scale with anchors of 1 (Does not describe) and 5 (Describes completely)

  Baseline and week 16

• Behavioral Regulation Action Planning (BRAP) Subscale

  The BRAP will be administered remotely for capturing the action planning construct. 5 items; Likert scale 1 - 4 (Not true - Completely true)

  Baseline and week 16

• Behavioral Regulation Action Control (BRAC) Subscale

  The BRAC will be administered remotely for capturing the action control construct. 6 items; Likert scale 1 - 4 (Not true - Completely true)

  Baseline and week 16

• HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)

  The Self-efficacy subscales will be administered remotely for capturing the self-efficacy levels in physical activity action, recovery, and maintenance. 9 items; Likert scale 1 - 4 (Not true - Exactly true)

  Baseline and week 16

• Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)

  The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)

  Baseline and week 16

• The PA-Related Social Support Scale (PASS)

  The PA-Related Social Support Scale will be administered remotely for capturing physical activity social support 7 items; Likert scale 1 - 4 (Almost never - Almost always)

  Baseline and week 16

• The Physical and Social Environment Barriers - Self-developed questionnaire

  The Physical and Social Environment Barriers will be administered remotely for capturing barriers in physical and social environment. 9 items; Likert scale 1 - 4 (Is not applicable - Applicable)

  Baseline and week 16

Secondary Outcomes (3)

• Physical Activity Behavior

  Baseline and week 16

• Physical Activity Behavior

  Baseline and week 16

• Formative Evaluation

  Week 16

Other Outcomes (2)

• Demographic information

  Baseline

• Clinical characteristics

  Baseline and week 16

Study Arms (2)

Treatment

EXPERIMENTAL

COM-B-based Physical Activity Behavior Intervention

Behavioral: COM-B-based Physical Activity Behavior Change Intervention

Waitlist Control

NO INTERVENTION

Interventions

COM-B-based Physical Activity Behavior Change Intervention BEHAVIORAL

Participants will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular chats over Zoom with a behavioral coach: The newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels. Throughout the 16-week period, the investigators will ask participants to wear a Fitbit and record step count into a logbook daily for tracking physical activity. The newsletter will be emailed to participants weekly throughout the program. The newsletters include knowledge, skills, and resources related to physical activity in the early stages of MS. The program also involves 7 1-on-1 coaching chats with a coach to guide participants through the program and navigate challenges. These chats are conducted over Zoom and generally last about 15 - 30 minutes each. These sessions will not be recorded.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• self-reported diagnosis of MS by a neurologist within the past 2 years
• relapse-free for the past 30 days
• ability to speak and read English as the primary language
• internet and e-mail access
• willingness to complete study protocol
• ambulatory without an assistive device (PDDS \< 3)
• insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) \< 14)
• visual ability and literacy to read newsletter with font size 14 points
• on a stable disease-modifying therapy for 6 months

You may not qualify if:

• pregnant
• have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Related Links

• Study Website

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Robert Motl, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lexi Huynh, PhD

CONTACT

312-996-6615; activnms@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The proposed study will utilize a parallel group, randomized controlled trial design. PNDwMS who are interested in participating in the study will be contacted to screen for eligibility and invited to participate if qualified. Participants will sign informed consent electronically using REDCap. The baseline assessment and follow-up assessments will be conducted remotely using an online REDCap battery of questionnaires. Following the baseline assessments, participants will be randomly (1:1) assigned to either the remotely delivered lifestyle physical activity intervention condition (focusing on walking) or waitlist control using computerized random numbers with allocation concealment. The physical activity behavior change intervention will be delivered over a 16-week period and supported through newsletters and Zoom-based chats guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model, by behavioral coaches who are uninvolved in random assignment and outcome assessment.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Pre-enrollment on ClinicalTrials.gov
• Access Criteria: No Criterial for access

Locations

US (1)