Multiple SclerosisActivNMSNCT07731659
Physical Activity Intervention for Individuals Newly Diagnosed With MS
A study testing COM-B-based Physical Activity Behavior Change Intervention in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- COM-B-based Physical Activity Behavior Change Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
Lexi Huynh, PhD, 312-996-6615, activnms@uic.edu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Multiple Sclerosis
- Being tested
- COM-B-based Physical Activity Behavior Change Intervention
- Keywords
- Physical Activity, Newly Diagnosed MS, Behavioral Intervention
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM-B-based Physical Activity Behavior Change InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | COM-B-based Physical Activity Behavior Intervention Receives: Behavioral: COM-B-based Physical Activity Behavior Change Intervention |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and week 16
Secondary outcomes (3)
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.
Measured: Baseline and week 16
Physical Activity Behavior
International Physical Activity Questionnaire (IPAQ); scores range between 0 (min) and 107 (max), higher scores indicate greater engagement in physical activity behavior.
Measured: Baseline and week 16
Formative Evaluation
Self-report survey to assess participant satisfaction and collect feedback from participant.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert W Motl, University of Illinois Chicago
- Investigators
- Robert Motl, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731659
- Sponsor's protocol ID
- STUDY2026-0787
- Acronym
- ActivNMS
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be shared. The data will be analyzed after follow-up data collection, and findings will be published on scientific journals
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Behavior Change Intervention in Persons Newly Diagnosed With Multiple Sclerosis - ActivNMS Trial - COM-B Construct Testing
- ClinicalTrials.gov ID
- NCT07731659
- Acronym / sponsor ID
- ActivNMS / STUDY2026-0787
- Conditions
- Multiple Sclerosis
- Keywords
- Physical Activity, Newly Diagnosed MS, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: COM-B-based Physical Activity Behavior Change InterventionCOM-B-based Physical Activity Behavior Intervention |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COM-B-based Physical Activity Behavior Change InterventionParticipants 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. | Behavioural | Treatment |
Primary outcome
Knowledge and Information Provision Questionnaire (NIP)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
3 secondary outcomes
Physical Activity Behavior
Time frame: Baseline and week 16
Physical Activity Behavior
Time frame: Baseline and week 16
Formative Evaluation
Time frame: Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data will not be shared. The data will be analyzed after follow-up data collection, and findings will be published on scientific journals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Motl, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COM-B-based Physical Activity Behavior Change Intervention in people with Multiple Sclerosis, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lexi Huynh, PhD (312-996-6615, activnms@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and Information Provision Questionnaire (NIP) (time frame: Baseline and week 16). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.