[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731659":3,"trial-entities:NCT07731659":129,"trial-summary:NCT07731659":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":70,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":99,"locations":102,"central_contacts":118,"overall_officials":120,"references":124,"see_also_links":125},"NCT07731659","STUDY2026-0787","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","NOT_YET_RECRUITING","2028-10-01","2026-07","2026-07-28","2026-10-01","University of Illinois at Chicago","OTHER",false,"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.\n\nSpecific 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.\n\nSpecific 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.","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\u002Fout 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.",[19],"Multiple Sclerosis",[21,22,23],"Physical Activity","Newly Diagnosed MS","Behavioral Intervention","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},50,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","COM-B-based Physical Activity Behavior Change Intervention","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:\n\nThe newsletters provide behavioral strategies such as information on the benefits of physical activity, goal setting and monitoring, for increasing and maintaining physical activity levels.\n\nThroughout 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.\n\nThe 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.\n\nThe 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.",[37],"Treatment",[39,43,46,49,52,55,58,61,64,67],{"measure":40,"description":41,"timeFrame":42},"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.\n\n3 items; Likert scale 1 - 4 (No - Yes, comprehensively)","Baseline and week 16",{"measure":44,"description":45,"timeFrame":42},"Multidimensional Outcome Expectations for Exercise Scale (MOEES)","The MOEES will be administered remotely for self-report assessment of outcome expectations for physical activity\u002Fexercise.\n\n15 items; Likert scale 1 - 5 (Strongly disagree - Strongly agree)",{"measure":47,"description":48,"timeFrame":42},"Behavioral Intention","The behavioral intention will be administered remotely for physical activity behavioral intentions.\n\n5 items; Likert scale 1- 4 (Not true - Completely true)",{"measure":50,"description":51,"timeFrame":42},"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)",{"measure":53,"description":54,"timeFrame":42},"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)",{"measure":56,"description":57,"timeFrame":42},"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)",{"measure":59,"description":60,"timeFrame":42},"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)",{"measure":62,"description":63,"timeFrame":42},"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)",{"measure":65,"description":66,"timeFrame":42},"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)",{"measure":68,"description":69,"timeFrame":42},"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.\n\n9 items; Likert scale 1 - 4 (Is not applicable - Applicable)",[71,74,76],{"measure":72,"description":73,"timeFrame":42},"Physical Activity Behavior","Godin Leisure-Time Exercise Questionnaire (GLTEQ); scores range between 0 (min) and 119 (max), higher scores indicate greater engagement in physical activity behavior.",{"measure":72,"description":75,"timeFrame":42},"International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.",{"measure":77,"description":78,"timeFrame":79},"Formative Evaluation","Self-report survey to assess participant satisfaction and collect feedback from participant.","Week 16","ALL","18 Years",null,{"inclusion":84,"exclusion":95,"raw_text":98},[85,86,87,88,89,90,91,92,93,94],"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 \\\u003C 3)","insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) \\\u003C 14)","visual ability and literacy to read newsletter with font size 14 points","on a stable disease-modifying therapy for 6 months",[96,97],"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)","Inclusion Criteria:\n\n* aged 18 years or older\n* self-reported diagnosis of MS by a neurologist within the past 2 years\n* relapse-free for the past 30 days\n* ability to speak and read English as the primary language\n* internet and e-mail access\n* willingness to complete study protocol\n* ambulatory without an assistive device (PDDS \\\u003C 3)\n* insufficiently active (Godin Leisure-Time Exercise Questionnaire (GLTEQ) \\\u003C 14)\n* visual ability and literacy to read newsletter with font size 14 points\n* on a stable disease-modifying therapy for 6 months\n\nExclusion Criteria:\n\n* pregnant\n* have an elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":104,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":115},"University of Illinois Chicago","Chicago","Illinois","60612","United States",[110],{"name":111,"role":112,"phone":113,"email":114},"Lexi Huynh, PhD","CONTACT","312-996-6615","activnms@uic.edu",{"lat":116,"lon":117},41.85003,-87.65005,[119],{"name":111,"role":112,"phone":113,"email":114},[121],{"name":122,"affiliation":13,"role":123},"Robert Motl, PhD","PRINCIPAL_INVESTIGATOR",[],[126],{"label":127,"url":128},"Study Website","https:\u002F\u002Fenrl.ahs.uic.edu\u002Fprojects\u002Factivms\u002F",{"nct_id":4,"conditions":130,"biomarkers":131},[19],[],{"nct_id":4,"found":133,"summary":134,"prompt_version":144},true,{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an interventional study designed to enroll 50 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to either receive the intervention or be in a control group.","completed","Physical Activity Intervention for Newly Diagnosed MS","This study is testing a 16-week remote physical activity program called the \"COM-B-based Physical Activity Behavior Change Intervention\" for people newly diagnosed with multiple sclerosis (MS). This program includes electronic newsletters and regular Zoom chats with a coach to help you become more active. Researchers want to see if this intervention helps you learn more about physical activity, feel more positive about exercising, and plan to be more active. You might be able to join if you are 18 or older, were diagnosed with MS within the last two years, are relapse-free for 30 days, can speak English, and have internet access. The study is currently unclear on its recruitment status and plans to enroll 50 participants.","Your knowledge, expectations, and intentions regarding exercise will be measured at the beginning of the study (Baseline) and again at week 16.",117,"If you join, you will participate in a 16-week remote physical activity program. This involves receiving electronic newsletters and having regular chats over Zoom with a behavioral coach.","Not stated in the trial record.",[34],"v2"]