ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

NCT04782466 | Active Not Recruiting DMC

• 2 other identifiers: 1000065261RG-1901-33188
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Pediatric Multiple Sclerosis

Keywords

Physical Activity; Exercise; Multiple Sclerosis; Demyelinating Disorders; Pediatric; Neurology; Children

Outcome Measures

Primary Outcomes (1)

• 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.

  Entire study - up to 18 months

Secondary Outcomes (3)

• Aerobic Capacity

  Entire study - up to 18 months

• Self-Reported PA Outcomes

  Entire study - up to 18 months

• Social Cognitive Theory Based Mediators of Physical Activity

  Entire study - up to 18 months

Other Outcomes (5)

• Tertiary Outcome Measures: Depression

  Entire study - up to 18 months

• Tertiary Outcome Measures: Quality of Life

  Entire study - up to 18 months

• Tertiary Outcome Measures: Fatigue

  Entire study - up to 18 months

Study Arms (2)

Intervention

EXPERIMENTAL

The participant receives the intervention immediately following baseline measurements.

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.

Behavioral: Waitlist attention-control

Interventions

Physical Activity (PA) Intervention BEHAVIORAL

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).

Intervention

Waitlist attention-control BEHAVIORAL

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.

Waitlist attention-control

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Children's Hospital of Philadelphia: collaborator
• University of Alabama at Birmingham: collaborator
• Queen's University: collaborator
• National Multiple Sclerosis Society: collaborator

Study Sites (3)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• Neuroinflammatory Disorders Program Research Website

MeSH Terms

Conditions

Motor Activity; Multiple Sclerosis; Demyelinating Diseases

Interventions

Exercise; Methods

Condition Hierarchy (Ancestors)

Behavior; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• E. Ann Yeh, MA, MD, FRCPC, Dip ABPN

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will receive both the intervention and the attention-control condition and will not be informed of which of the procedures is the active intervention condition. The statistician, PI, and fitness testers, and physical activity data analysts will be blinded to the group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist, Division of Neuroscience and Mental Health, SickKids Research Institute

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 4, 2021
• Study Start: December 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)