Pediatric Multiple SclerosisNCT04782466
ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
A study testing Physical Activity (PA) Intervention in people with Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 3 sites in 2 countries.
Trial summary
The investigators have previously shown that youth with MS are very inactive, and that vigorous physical activity is associated with higher levels of well-being and lower MS disease activity in youth. Yet, no effective physical activity interventions have been developed for youth with MS to date. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Pediatric Multiple Sclerosis
- What is being tested?
- Physical Activity (PA) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Dec 2020to Sep 2025
- 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 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Youth 11-21 years of age;
- MS diagnosis or clinically isolated syndrome, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria prior to the age of 18;
- Participating in less than three hours of structured physical activity per week.
Who cannot join
- Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities;
- Do not speak and read English at a level needed to complete the questionnaires (4th grade level);
- Have significant motor disability, classified as an Expanded Disability Status Scale (EDSS) ≥4;
- Are at increased risk of cardiac or other complications of exercise testing (e.g. cardiac disease, diabetes), as determined by the pediatric neurologist or physician.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Physical Activity, Quality of Life and Disease Outcomes in Youth With Multiple Sclerosis: the ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
The investigators have previously shown that youth with MS are very inactive, and that vigorous physical activity is associated with higher levels of well-being and lower MS disease activity in youth. Yet, no effective physical activity interventions have been developed for youth with MS to date. The investigators have taken input from youth with MS to create a Smartphone-based app (the ATOMIC - Active Teens with Multiple Sclerosis - App) that provides tailored physical activity information and coaching, provides tools to increase social connectedness, and promotes physical activity. This proposed research will therefore address the problem of inactivity in youth with MS by studying an intervention to increase physical activity.
Read the detailed description
Youth with MS have highly active disease and report high levels of fatigue and depression. As MS is a lifetime diagnosis, amelioration of these outcomes may have a sustained and important effect on the lives of these youth. Effective interventions oriented towards improving these outcomes are therefore imperative to develop and study. Importantly, recent work suggests that increased PA has the potential to improve brain tissue integrity, re-myelination, mental health outcomes, and quality of life in youth with MS. The investigators have demonstrated associations between lower levels of PA and higher levels of depressive symptoms and fatigue in these youth over time. Furthermore, the investigators have demonstrated an association between higher levels of PA and lower levels of disease activity in youth with MS. Importantly, preliminary work by the investigators shows that youth with MS have very low levels of PA. Increasing PA, therefore, has the potential to have both disease-modifying and psychosocial benefits in youth with MS.
The investigators have developed a user-driven app and program, the ATOMIC intervention, which addresses barriers to PA participation the investigators previously identified. The program provides youth with tools to increase goal setting, PA self-efficacy, and knowledge, and is embedded in a youth-focused app that is supported by health coaches. Notably, in preliminary work, the investigators have found the ATOMIC program to be acceptable to youth, and furthermore, that it was associated with a 31% increase in physical activity.
These strong preliminary results support moving forward with this proposed research, a multi-center randomized wait-list controlled trial (RCT) of the ATOMIC mobile app and coaching-based physical activity (PA) intervention in youth with multiple sclerosis (MS). The proposed study will examine the extent to which the intervention can change PA levels in this cohort. Additional goals will be to evaluate the effect of the ATOMIC intervention on behavioural change mediators, fitness, and psychosocial outcomes.
For this study, the investigators will recruit 56 youth with MS followed at three tertiary children's hospitals with large, established pediatric MS programs: The Hospital for Sick Children, Children's Hospital of Philadelphia, and the University of Alabama at Birmingham.
- Conditions
- Pediatric Multiple Sclerosis
- Being tested
- Physical Activity (PA) Intervention, Waitlist attention-control
- Keywords
- Physical Activity, Exercise, Multiple Sclerosis, Demyelinating Disorders, Pediatric, Neurology, Children
- Medical subject headings
- Motor Activity, Multiple Sclerosis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity (PA) InterventionBehavioural
The ATOMIC intervention consists of four primary components: one-on-one chats with a PA coach, informational posts, PA self-monitoring through an activity tracker and educational modules regarding different aspects of becoming PA delivered through the MS-specific PA app. An overarching goal of moving youth with MS towards meeting current Moderate to Vigorous Physical Activity (MVPA) recommendations will be used in addition to initial results from accelerometer monitoring and evaluation of current PA intentions to establish step goals, with planned weekly incremental increases (10% weekly to goal).
Waitlist attention-controlBehavioural
For a period of 6-months, participants will receive the control conditions that involve contact from study personnel and a nutritional educational module to ensure equivalent social contact in both arms of the study. After the 6-months, participants will receive the same intervention as the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participant receives the intervention immediately following baseline measurements. Receives: Behavioral: Physical Activity (PA) Intervention |
| Waitlist attention-control | Other | The participant receives the control condition for 6 months following baseline measurements. After 6 months, the baseline measurements are repeated and then the participant receives the intervention. Receives: Behavioral: Waitlist attention-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Accelerometry is a valid device-based physical activity measurement tool that will be used to determine physical activity. Children will be asked to wear the accelerometer daily for a week, and the investigators will analyze cases that have four or more days of data with ≥10 hours of wear time per day. The investigators will process the accelerometer data and use step counts as well as validated cut-offs to determine time spent in sedentary, light, and Moderate to Vigorous Physical Activity (MVPA) (minutes/day). The focus of the investigators will be to determine the effect of the ATOMIC intervention on device-measured physical activity levels.
Measured: Entire study - up to 18 months
Secondary outcomes (3)
Aerobic Capacity
The investigators will determine cardiorespiratory fitness by measuring peak oxygen uptake (VO2Peak) using a maximal exercise test on a cycle ergometer.
Measured: Entire study - up to 18 months
Self-Reported PA Outcomes
The Godin Leisure-Time Exercise Questionnaire (GLTEQ) will be used to self-report physical activity outcomes. This self-report 7-day activity recall scale has been validated in the pediatric population and in the pediatric MS population.
Measured: Entire study - up to 18 months
Social Cognitive Theory Based Mediators of Physical Activity
This is a composite set of questionnaires used to evaluate Social Cognitive Theory (SCT) based mediator. The focus of the investigators will be to determine the effect of the intervention on social cognitive theory mediators of PA.
Measured: Entire study - up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Dec 2020
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Multiple SclerosisStudies of the same condition, open and under way.
- 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
- At baseline, participants will be randomized using online research randomizer software, in blocks of 2 each, balanced for the clinical site, sex, and pubertal status (using self-selected Tanner staging), which may independently predict physical fitness level and has also been associated with physical activity level especially in adolescent girls to either a 6-month PA intervention or waitlist attention-control condition. The research coordinator will request the randomization of the participant as provided by the online research randomizer at the completion of the baseline test and will inform the study participant of their assigned study arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Alabama at Birmingham, Queen's University, National Multiple Sclerosis Society
- Responsible party
- Principal investigator, E. Ann Yeh, The Hospital for Sick Children
- Investigators
- E. Ann Yeh, MA, MD, FRCPC, Dip ABPN, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782466
- Sponsor's protocol ID
- 1000065261
- Other IDs
- RG-1901-33188
- Status last verified
- May 2025
- First submitted
- 23 Feb 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Quality of Life and Disease Outcomes in Youth With Multiple Sclerosis: the ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
- ClinicalTrials.gov ID
- NCT04782466
- Acronym / sponsor ID
- 1000065261
- Conditions
- Pediatric Multiple Sclerosis
- Keywords
- Physical Activity, Exercise, Multiple Sclerosis, Demyelinating Disorders, Pediatric, Neurology, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, University of Alabama at Birmingham, Queen's University, National Multiple Sclerosis Society
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 4 Mar 2021 (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 investigators have previously shown that youth with MS are very inactive, and that vigorous physical activity is associated with higher levels of well-being and lower MS disease activity in youth. Yet, no effective physical activity interventions have been developed for youth with MS to date. The investigators have taken input from youth with MS to create a Smartphone-based app (the ATOMIC - Active Teens with Multiple Sclerosis - App) that provides tailored physical activity information and coaching, provides tools to increase social connectedness, and promotes physical activity. This proposed research will therefore address the problem of inactivity in youth with MS by studying an intervention to increase physical activity.
Detailed description
Youth with MS have highly active disease and report high levels of fatigue and depression. As MS is a lifetime diagnosis, amelioration of these outcomes may have a sustained and important effect on the lives of these youth. Effective interventions oriented towards improving these outcomes are therefore imperative to develop and study. Importantly, recent work suggests that increased PA has the potential to improve brain tissue integrity, re-myelination, mental health outcomes, and quality of life in youth with MS. The investigators have demonstrated associations between lower levels of PA and higher levels of depressive symptoms and fatigue in these youth over time. Furthermore, the investigators have demonstrated an association between higher levels of PA and lower levels of disease activity in youth with MS. Importantly, preliminary work by the investigators shows that youth with MS have very low levels of PA. Increasing PA, therefore, has the potential to have both disease-modifying and psychosocial benefits in youth with MS.
The investigators have developed a user-driven app and program, the ATOMIC intervention, which addresses barriers to PA participation the investigators previously identified. The program provides youth with tools to increase goal setting, PA self-efficacy, and knowledge, and is embedded in a youth-focused app that is supported by health coaches. Notably, in preliminary work, the investigators have found the ATOMIC program to be acceptable to youth, and furthermore, that it was associated with a 31% increase in physical activity.
These strong preliminary results support moving forward with this proposed research, a multi-center randomized wait-list controlled trial (RCT) of the ATOMIC mobile app and coaching-based physical activity (PA) intervention in youth with multiple sclerosis (MS). The proposed study will examine the extent to which the intervention can change PA levels in this cohort. Additional goals will be to evaluate the effect of the ATOMIC intervention on behavioural change mediators, fitness, and psychosocial outcomes.
For this study, the investigators will recruit 56 youth with MS followed at three tertiary children's hospitals with large, established pediatric MS programs: The Hospital for Sick Children, Children's Hospital of Philadelphia, and the University of Alabama at Birmingham.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- At baseline, participants will be randomized using online research randomizer software, in blocks of 2 each, balanced for the clinical site, sex, and pubertal status (using self-selected Tanner staging), which may independently predict physical fitness level and has also been associated with physical activity level especially in adolescent girls to either a 6-month PA intervention or waitlist attention-control condition. The research coordinator will request the randomization of the participant as provided by the online research randomizer at the completion of the baseline test and will inform the study participant of their assigned study arm.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical Activity (PA) InterventionThe participant receives the intervention immediately following baseline measurements. |
| Waitlist attention-control | Other | Behavioral: Waitlist attention-controlThe participant receives the control condition for 6 months following baseline measurements. After 6 months, the baseline measurements are repeated and then the participant receives the intervention. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Youth 11-21 years of age;
- MS diagnosis or clinically isolated syndrome, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria prior to the age of 18;
- Participating in less than three hours of structured physical activity per week.
Key exclusion criteria (4 listed)
- Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities;
- Do not speak and read English at a level needed to complete the questionnaires (4th grade level);
- Have significant motor disability, classified as an Expanded Disability Status Scale (EDSS) ≥4;
- Are at increased risk of cardiac or other complications of exercise testing (e.g. cardiac disease, diabetes), as determined by the pediatric neurologist or physician.
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 |
|---|---|---|
| Physical Activity (PA) InterventionThe ATOMIC intervention consists of four primary components: one-on-one chats with a PA coach, informational posts, PA self-monitoring through an activity tracker and educational modules regarding different aspects of becoming PA delivered through the MS-specific PA app. An overarching goal of moving youth with MS towards meeting current Moderate to Vigorous Physical Activity (MVPA) recommendations will be used in addition to initial results from accelerometer monitoring and evaluation of current PA intentions to establish step goals, with planned weekly incremental increases (10% weekly to goal). | Behavioural | Intervention |
| Waitlist attention-controlFor a period of 6-months, participants will receive the control conditions that involve contact from study personnel and a nutritional educational module to ensure equivalent social contact in both arms of the study. After the 6-months, participants will receive the same intervention as the intervention arm. | Behavioural | Waitlist attention-control |
Primary outcome
Physical Activity Level
Time frame: Entire study - up to 18 months
Accelerometry is a valid device-based physical activity measurement tool that will be used to determine physical activity. Children will be asked to wear the accelerometer daily for a week, and the investigators will analyze cases that have four or more days of data with ≥10 hours of wear time per day. The investigators will process the accelerometer data and use step counts as well as validated cut-offs to determine time spent in sedentary, light, and Moderate to Vigorous Physical Activity (MVPA) (minutes/day). The focus of the investigators will be to determine the effect of the ATOMIC intervention on device-measured physical activity levels.
3 secondary outcomes
Aerobic Capacity
Time frame: Entire study - up to 18 months
Self-Reported PA Outcomes
Time frame: Entire study - up to 18 months
Social Cognitive Theory Based Mediators of Physical Activity
Time frame: Entire study - up to 18 months
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 23 Sep 2025.
- Neuroinflammatory Disorders Program Research WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
E. Ann Yeh, MA, MD, FRCPC, Dip ABPN principal investigator
The Hospital for Sick Children
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity (PA) Intervention in people with Pediatric Multiple Sclerosis, run by The Hospital for Sick Children at 3 sites in 2 countries.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: Entire study - up to 18 months). 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 23 Sep 2025.