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临床试验/NCT07731659
NCT07731659尚未招募不适用

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

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Knowledge and Information Provision Questionnaire (NIP)

研究概览

简要总结

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.

详细描述

Multiple sclerosis (MS) is a prevalent neurological disease of the central nervous system that is the leading cause of neurological disability among young adults in the United States. This disease results in the progressive loss of walking, substantial worsening of cognition, symptoms of fatigue, as well as compromised quality of life (QoL). There is evidence that physical activity is beneficially associated with walking mobility, cognitive function, symptoms of fatigue, depression, anxiety, and pain in persons with MS. Nonetheless, this population is strikingly sedentary and physically inactive, including persons newly diagnosed with MS (diagnosed with MS for two years or less). Indeed, approximately 40% of persons with MS reported stopping physical activity after an MS diagnosis, and persons recently diagnosed with MS have not been included in physical activity intervention research. Yet, the early stage of MS represents an ideal time point for initiating physical activity for life-long benefits. There is further evidence that physical activity and exercise interventions delivered remotely can yield benefits in managing MS symptoms and comorbidities, and disability progression. In this study, the investigators aim to primarily test the effect of a 16-week remotely delivered behavioral intervention, compared with a control condition (i.e., waitlist control), on the psychological constructs based on the Capability-Opportunity-Motivation-Behavior model in persons newly diagnosed with MS (disease duration ≤ 2 years). Consequently, this could provide more evidence for the understanding of the intervention mechanism on physical activity behavior in people newly diagnosed with MS. Participants will complete a battery of questionnaires remotely over the internet before and immediately after the 16-week program. The first assessments occur upon enrollment in the study (Baseline Assessment) and the second occurs right after the intervention (16- week Assessment). In this study, participants will be randomly assigned into 1 of 2 conditions: a physical activity condition (receive the intervention immediately after baseline assessment) or a waitlist condition (receive the intervention after the 16-week assessment). Participants in both conditions will receive access to an Internet delivered program for 16 weeks as well as one-on-one coaching through Zoom. The participants could opt in/out of receiving the intervention after the follow-up assessment. The investigators will ask that participants in the physical activity condition wear a Fitbit (this is different from the accelerometer) for tracking physical activity daily during the 16- week period. The investigators will further ask that information from the Fitbit be recorded into a logbook daily.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Knowledge and Information Provision Questionnaire (NIP)

时间窗: Baseline and week 16

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)

Multidimensional Outcome Expectations for Exercise Scale (MOEES)

时间窗: Baseline and week 16

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)

Behavioral Intention

时间窗: Baseline and week 16

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

Exercise Goal Setting Scale (EGS)

时间窗: Baseline and week 16

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)

Behavioral Regulation Action Planning (BRAP) Subscale

时间窗: Baseline and week 16

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

Behavioral Regulation Action Control (BRAC) Subscale

时间窗: Baseline and week 16

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

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

时间窗: Baseline and week 16

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)

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

时间窗: Baseline and week 16

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

The PA-Related Social Support Scale (PASS)

时间窗: Baseline and week 16

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)

The Physical and Social Environment Barriers - Self-developed questionnaire

时间窗: Baseline and week 16

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)

次要结局

  • Physical Activity Behavior(Baseline and week 16)
  • Formative Evaluation(Week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert W Motl

Principal Investigator

University of Illinois at Chicago

研究点 (1)

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