Clinical trial NCT03829267: eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With MS
Official title: eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: exercise
physical activity
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Cannot be available for the next 12 weeks consecutively

Primary outcomes:
measure: Adherence rate: Percentage of weekly eFIT group meetings that participants attend
timeFrame: 12-weeks
measure: Completion rate: Percentage of enrolled participants who complete follow-up questionnaires
timeFrame: 12-weeks
Secondary outcomes:
measure: Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)
timeFrame: 12-weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12-weeks
measure: UCLA Loneliness Scale
timeFrame: 12-weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Multiple Sclerosis Clinical Care and Research
state: New York
Study officials:
affiliation: Assistant Professor of Neuropsychology
name: Victoria Leavitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.
citation: Leavitt VM, Aguerre IM, Lee N, Riley CS, De Jager PL, Bloom S. RCT of a Telehealth Group-Based Intervention to Increase Physical Activity in Multiple Sclerosis: eFIT. Neurol Clin Pract. 2021 Aug;11(4):291-297. doi: 10.1212/CPJ.0000000000001039.