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Physical Activity Intervention for Individuals Newly Diagnosed With MS

Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 16 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less)."
  • "Participants will complete a battery of questionnaires remotely over the internet before and immediately after the 16-week program."
  • "Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 16-week online program with one-on-one video coaching and newsletters for adults diagnosed with multiple sclerosis (MS) in the past 2 years. It looks at whether the program changes physical activity and factors such as confidence, motivation, and support, compared with a group on a waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, and report that a neurologist diagnosed you with MS in the past 2 years.
  • No MS relapse, or flare-up, in the past 30 days.
  • English is your main language, and you can speak and read it.
  • Have internet and email access, and are willing to complete the study.
  • Can walk without a device such as a cane or walker (PDDS score below 3).
  • Are not active enough, based on an exercise questionnaire score below 14.
  • Can see and read newsletters printed in 14-point type.
  • Have been on a stable MS treatment that changes the course of the disease for 6 months.

Who can't join

  • Are pregnant.
  • Have a higher risk from hard or maximum-effort exercise, based on 2 or more “yes” answers on an exercise readiness questionnaire.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Study sites (1)

IL