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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: eFIT Intervention; Behavioral: eJournal Intervention; Behavioral: Treatment as usual

• Registration Number: NCT03829267
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-04-26
• Primary Completion: 2020-04-13
• Study Completion: 2020-04-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Age 18 or older
• Diagnosis of multiple sclerosis

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Exclusion Criteria

• Cannot be available for the next 12 weeks consecutively

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eFIT Behavioral Intervention	eFIT 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.
eFIT Behavioral Intervention	Treatment as usual	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.
eJournal Behavioral Intervention	eJournal 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.
eJournal Behavioral Intervention	Treatment as usual	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.

Primary Outcome Measures

Name	Time	Method
Adherence rate: Percentage of weekly eFIT group meetings that participants attend	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
Completion rate: Percentage of enrolled participants who complete follow-up questionnaires	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

Name	Time	Method
Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)	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.
Patient Health Questionnaire-9 (PHQ-9)	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.
UCLA Loneliness Scale	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.

Trial Locations

Locations (1)

Columbia University Multiple Sclerosis Clinical Care and Research; 🇺🇸 New York, New York, United States