NCT04782466

ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

Physical Activity, Quality of Life and Disease Outcomes in Youth With Multiple Sclerosis: the ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 11 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
BEHAVIORAL	Physical Activity (PA) Intervention	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).
BEHAVIORAL	Waitlist attention-control	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.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2021-03-04
• Last updated: 2025-09-23

Locations

3 sites across 2 countries: United States, Canada