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

NCT ID: NCT03829267

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-26
• Study Completion Date: 2020-04-13

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

eFIT Intervention

Intervention Type: BEHAVIORAL

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

Treatment as usual

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

eJournal Intervention

Intervention Type: BEHAVIORAL

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

Treatment as usual

Intervention Type: 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.

Interventions

eFIT Intervention

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

Intervention Type: BEHAVIORAL

eJournal Intervention

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 or older
• Diagnosis of multiple sclerosis

Exclusion Criteria

• Cannot be available for the next 12 weeks consecutively

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Victoria M. Leavitt

Assistant Professor of Neuropsychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Leavitt, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Neuropsychology

Locations

Columbia University Multiple Sclerosis Clinical Care and Research

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 7823386 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34484928 (View on PubMed)

Other Identifiers

AAAR4052-2

Identifier Type: -

Identifier Source: org_study_id