Physical Activity Intervention for Individuals Newly Diagnosed With MS (ActivNMS)
Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing
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.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Lexi Huynh, PhD
- 电话号码:312-996-6615
- 邮箱:activnms@uic.edu
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- University of Illinois Chicago
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接触:
- Lexi Huynh, PhD
- 电话号码:312-996-6615
- 邮箱:activnms@uic.edu
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:候补名单控制
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实验性的:Treatment
COM-B-based Physical Activity Behavior Intervention
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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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Knowledge and Information Provision Questionnaire (NIP)
大体时间:Baseline and week 16
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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
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Multidimensional Outcome Expectations for Exercise Scale (MOEES)
大体时间:Baseline and week 16
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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
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Behavioral Intention
大体时间:Baseline and week 16
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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
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Exercise Goal Setting Scale (EGS)
大体时间:Baseline and week 16
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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)
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Baseline and week 16
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Behavioral Regulation Action Planning (BRAP) Subscale
大体时间:Baseline and week 16
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The BRAP will be administered remotely for capturing the action planning construct.
5 items; Likert scale 1 - 4 (Not true - Completely true)
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Baseline and week 16
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Behavioral Regulation Action Control (BRAC) Subscale
大体时间:Baseline and week 16
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The BRAC will be administered remotely for capturing the action control construct.
6 items; Likert scale 1 - 4 (Not true - Completely true)
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Baseline and week 16
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HAPA Self-efficacy Subscales (Action, Recovery, Maintenance Subscale)
大体时间:Baseline and week 16
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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)
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Baseline and week 16
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Hamburg Quality of Life Questionnaire Multiple Sclerosis - Fatigue Subscale (HAQUAMSF)
大体时间:Baseline and week 16
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The HAQUAMSF will be administered remotely for measuring fatigue 4 items; Likert scale 1 - 5 (Not at all - Very much)
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Baseline and week 16
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The PA-Related Social Support Scale (PASS)
大体时间:Baseline and week 16
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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)
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Baseline and week 16
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The Physical and Social Environment Barriers - Self-developed questionnaire
大体时间:Baseline and week 16
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Activity Behavior
大体时间:Baseline and week 16
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Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.
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Baseline and week 16
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Physical Activity Behavior
大体时间:Baseline and week 16
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International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
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Baseline and week 16
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Formative Evaluation
大体时间:Week 16
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Self-report survey to assess participant satisfaction and collect feedback from participant.
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Week 16
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Demographic information
大体时间:Baseline
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Self-report questionnaire will be administered remotely to capture age, sex, race, ethnicity, education, marital status, income
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Baseline
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Clinical characteristics
大体时间:Baseline and week 16
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Self-report questionnaire will be administered remotely to capture MS type, disease duration, Patient Determined Disease Steps (PDDS)
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Baseline and week 16
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合作者和调查者
调查人员
- 首席研究员:Robert Motl, PhD、University of Illinois at Chicago
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY2026-0787
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
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