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

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ClinicalTrials.gov Identifier: NCT03829267
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Victoria M. Leavitt, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: eFIT Intervention Behavioral: eJournal Intervention Behavioral: Treatment as usual Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
Masking: Single (Investigator)
Masking Description: Participants will be enrolled in an internet-based intervention to increase physical activity. Only the PI will know whether participants are in the SNAP or eJournal condition.
Primary Purpose: Treatment
Official Title: eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis
Actual Study Start Date : April 26, 2019
Actual Primary Completion Date : April 13, 2020
Actual Study Completion Date : April 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: eFIT Behavioral Intervention
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
eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis

Behavioral: Treatment as usual
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.

Active Comparator: eJournal Behavioral Intervention
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
1-hour online each week engaged in an active journaling activity

Behavioral: Treatment as usual
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.




Primary Outcome Measures :
  1. Adherence rate: Percentage of weekly eFIT group meetings that participants attend [ Time Frame: 12-weeks ]
    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

  2. Completion rate: Percentage of enrolled participants who complete follow-up questionnaires [ Time Frame: 12-weeks ]
    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.


Secondary Outcome Measures :
  1. Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level) [ Time Frame: 12-weeks ]
    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.

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 12-weeks ]
    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.

  3. UCLA Loneliness Scale [ Time Frame: 12-weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of multiple sclerosis

Exclusion Criteria:

  • Cannot be available for the next 12 weeks consecutively

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): NCT03829267


Locations
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United States, New York
Columbia University Multiple Sclerosis Clinical Care and Research
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Victoria Leavitt, MD Assistant Professor of Neuropsychology
Publications:
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Responsible Party: Victoria M. Leavitt, Assistant Professor of Neuropsychology, Columbia University
ClinicalTrials.gov Identifier: NCT03829267    
Other Study ID Numbers: AAAR4052-2
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
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 Victoria M. Leavitt, Columbia University:
exercise
physical activity
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