eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With MS

Study Overview
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Brief Summary
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eFIT is a technology-enabled internet based psychosocial intervention to increase physical activity in persons with multiple sclerosis, who are at unique risk for sedentary behaviors and for whom exercise and physical activity hold many benefits.

Detailed Description
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This is a randomized controlled trial of an internet-based intervention to increase physical activity in persons with multiple sclerosis. Multiple sclerosis (MS) is the most common non-traumatic neurological cause of disability in young adults. Sedentary behavior, now recognized as a major contributor to increased morbidity is seen at higher rates and related to adverse health outcomes for persons with MS (PwMS). Prominent symptoms of MS (motor impairment, fatigue, depressed mood, pain), place this population at unique risk for increased sedentary behavior. And importantly, with increased age comes increased risk: patients over 60 are significantly more sedentary than middle-aged patients. On a positive note, current disease modifying therapies prolong time to disease progression, widening the window of opportunity for implementing behavioral interventions that support health and successful aging. Behaviors adopted early in life are more likely to be maintained into later adulthood. Physical activity is beneficial for PwMS on multiple levels: improved gait and balance, improved cognition, reduced depression and fatigue. Finding ways to increase physical activity is a key research priority for MS. Behavioral change is difficult to adopt and even more difficult to maintain. Here, we introduce a novel behavioral intervention to increase physical activity, eFIT, a technology-enabled (i.e., internet-delivered) support group-based treatment that leverages accountability to motivate and sustain behavioral change. Accountability constitutes the bedrock underlying the single most pervasive, successful, and widely embraced behavioral intervention known: Alcoholics Anonymous (AA). Through sponsors and support groups, AA utilizes accountability partners to deliver, reinforce, and sustain life-saving behavioral change. Here, we leverage accountability partners to motivate enduring behavioral change in physical activity participation, one of the single most difficult health behaviors to implement and maintain.

Official Title
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eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: eFIT Intervention
* Behavioral: eJournal Intervention
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Diagnosis of multiple sclerosis Exclusion Criteria: Cannot be available for the next 12 weeks consecutively

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eFIT Behavioral Intervention<br>Intervention: Participants randomized to the eFIT condition will join a 1-hour peer group meeting online each week, called eFIT intervention. They will learn about accountability partners, and use the group as an accountability partner to state and attain physical fitness goals. | Behavioral: eFIT Intervention<br>* eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis<br>Behavioral: Treatment as usual<br>* Participants in this condition will complete baseline and follow-up surveys with the same frequency as the active treatment groups, but will receive neither eFIT nor eJournal.<br>|
| Active Comparator: eJournal Behavioral Intervention<br>Intervention: Participants in the eJournal condition will spend 1-hour online each week engaged in an active journaling activity, called eJournal Intervention. They will also receive the same psychoeducational materials online as the eFIT participants are presented in group. | Behavioral: eJournal Intervention<br>* 1-hour online each week engaged in an active journaling activity<br>Behavioral: Treatment as usual<br>* Participants in this condition will complete baseline and follow-up surveys with the same frequency as the active treatment groups, but will receive neither eFIT nor eJournal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate: Percentage of weekly eFIT group meetings that participants attend | Assess feasibility of the program: Acceptability of intervention based on attendance rates of participants meeting the criteria of attendance at two-thirds of the meetings over 12-weeks | 12-weeks | 
| Completion rate: Percentage of enrolled participants who complete follow-up questionnaires | Assess feasibility of the program: to retain and obtain completed questionnaires at immediate follow-up from two-thirds of enrolled participants meeting the criteria of two-thirds attendance. | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level) | International Physical Activity Questionnaire (IPAQ)-Long form includes 27 items divided into 5 subscales. For this trial, the total minutes/hours/days for items 1-25 will be calculated. Higher scores indicate more time spent engaged in physical activity. Items 26 and 27 will be excluded in the variable because they query about time spent sitting. | 12-weeks | 
| Patient Health Questionnaire-9 (PHQ-9) | Assess efficacy of the program to improve mood as defined by an increase in total score on PHQ-9. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. Total score ranges from 0 to 27, with higher scores indicating worse depression. | 12-weeks | 
| UCLA Loneliness Scale | Assess efficacy of the program to decrease loneliness as defined by a decrease in total score on UCLA Loneliness Scale. This name never appears as anything other than UCLA Loneliness Scale, i.e. Russell 1996). Total score ranges from 0 to 60, with higher scores indicating worse loneliness. | 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, physical activity