ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program
- Conditions
- Pediatric Multiple Sclerosis
- Interventions
- Behavioral: Waitlist attention-controlBehavioral: Physical Activity (PA) Intervention
- Registration Number
- NCT04782466
- Lead Sponsor
- The Hospital for Sick Children
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist attention-control Waitlist attention-control 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. Intervention Physical Activity (PA) Intervention The participant receives the intervention immediately following baseline measurements.
- Primary Outcome Measures
Name Time Method Physical Activity Level 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.
- Secondary Outcome Measures
Name Time Method Aerobic Capacity Entire study - up to 18 months The investigators will determine cardiorespiratory fitness by measuring peak oxygen uptake (VO2Peak) using a maximal exercise test on a cycle ergometer.
Self-Reported PA Outcomes Entire study - up to 18 months 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.
Social Cognitive Theory Based Mediators of Physical Activity Entire study - up to 18 months 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.
Trial Locations
- Locations (3)
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada