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ATOMIC (Active Teens Multiple Sclerosis) Physical Activity Research Program

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ClinicalTrials.gov Identifier: NCT04782466
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : June 4, 2021
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
University of Alabama at Birmingham
Queen's University
National Multiple Sclerosis Society
Information provided by (Responsible Party):
E. Ann Yeh, 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.

Condition or disease Intervention/treatment Phase
Pediatric Multiple Sclerosis Behavioral: Physical Activity (PA) Intervention Behavioral: Waitlist attention-control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: Intervention
The participant receives the intervention immediately following baseline measurements.
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).

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Aerobic Capacity [ Time Frame: 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.

  2. Self-Reported PA Outcomes [ Time Frame: 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.

  3. Social Cognitive Theory Based Mediators of Physical Activity [ Time Frame: 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.


Other Outcome Measures:
  1. Tertiary Outcome Measures: Depression [ Time Frame: Entire study - up to 18 months ]
    The Centre for Epidemiological Studies Depression Scale Children's Rating Scale (CES-DC) is a valid and reliable 20-item, self-rated, symptom-oriented scale suitable for people aged six to 23.

  2. Tertiary Outcome Measures: Quality of Life [ Time Frame: Entire study - up to 18 months ]
    The Varni Pediatric Quality of Life Inventory - Core Module (PedsQL) is a 23-item scale that measures social, physical, emotional, school functioning quality of life that has been shown to be a valid and reliable measure of quality of life in children with chronic conditions.

  3. Tertiary Outcome Measures: Fatigue [ Time Frame: Entire study - up to 18 months ]
    The Varni Pediatric Multidimensional Fatigue Scale (PedsQL-MFS) is a validated and reliable 18-item, self-rated (parent and self-report), symptom-oriented scale suitable for youths aged 8 to 18 that includes fatigue subscales (general, sleep/rest and cognitive fatigue).

  4. Tertiary Outcome Measures: Cognitive Function [ Time Frame: Entire study - up to 18 months ]
    The Symbol Digit Modalities Test (SDMT) is a widely used, validated paper and pencil neurocognitive test which assesses processing speed (i.e. the speed of thinking). It validated and used widely in pediatric multiple sclerosis.

  5. Tertiary Outcome Measures: Anxiety [ Time Frame: Entire study - up to 18 months ]
    The Screen for Anxiety Related Disorders (SCARED) scale is a validated and reliable 41-item, self-rated, symptom score suitable for youths ages 9 to 18.



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Ages Eligible for Study:   11 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Youth 11-21 years of age;
  2. 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;
  3. Participating in less than three hours of structured physical activity per week.

Exclusion Criteria:

  1. Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities;
  2. Do not speak and read English at a level needed to complete the questionnaires (4th grade level);
  3. Have significant motor disability, classified as an Expanded Disability Status Scale (EDSS) ≥4;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782466


Contacts
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Contact: E. Ann Yeh, MA, MD, FRCPC, Dip ABPN 416-813-7654 ext 207353 ann.yeh@sickkids.ca
Contact: Olivia Lau 416-813-7654 ext 328577 olivia.lau@sickkids.ca

Locations
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United States, Alabama
The University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Robert Motl, PhD    205-934-5905    robmotl@uab.edu   
Contact: Whitney Neal, MA, CHES    205-996-0825    wnneal@uab.edu   
Principal Investigator: Robert Motl, PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brenda Banwell, MD       banwellb@email.chop.edu   
Contact: Jessica Legaspi    267-426-5092    legaspij1@email.chop.edu   
Principal Investigator: Brenda Banwell, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Olivia Lau    416-813-7654 ext 328577    olivia.lau@sickkids.ca   
Contact: Samantha Stephens, PhD    416-813-7654 ext 328936    samantha.stephens@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Children's Hospital of Philadelphia
University of Alabama at Birmingham
Queen's University
National Multiple Sclerosis Society
Investigators
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Principal Investigator: E. Ann Yeh, MA, MD, FRCPC, Dip ABPN The Hospital for Sick Children
Additional Information:
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Responsible Party: E. Ann Yeh, Senior Associate Scientist, Division of Neuroscience and Mental Health, SickKids Research Institute, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04782466    
Other Study ID Numbers: 1000065261
RG-1901-33188 ( Other Grant/Funding Number: National Multiple Sclerosis Society )
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: June 4, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by E. Ann Yeh, The Hospital for Sick Children:
Physical Activity
Exercise
Multiple Sclerosis
Demyelinating Disorders
Pediatric
Neurology
Children
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases