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Completed

NCT Number: NCT03829267

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Multiple Sclerosis Clinical Care and Research

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Diagnosis of multiple sclerosis

Exclusion criteria

  • Cannot be available for the next 12 weeks consecutively

Treatment and study plan

eFIT Intervention

Behavioral

eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis

eJournal Intervention

Behavioral

1-hour online each week engaged in an active journaling activity

Treatment as Usual

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Acronym: eFIT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 4, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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