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

NCT03829267 | Completed

• 1 other identifier: AAAR4052-2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

exercise; physical activity

Outcome Measures

Primary Outcomes (2)

• Adherence rate: Percentage of weekly eFIT group meetings that participants attend

  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

  12-weeks

• Completion rate: Percentage of enrolled participants who complete follow-up questionnaires

  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.

  12-weeks

Secondary Outcomes (3)

• Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)

  12-weeks

• Patient Health Questionnaire-9 (PHQ-9)

  12-weeks

• UCLA Loneliness Scale

  12-weeks

Study Arms (2)

eFIT Behavioral Intervention

EXPERIMENTAL

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; Behavioral: Treatment as usual

eJournal Behavioral Intervention

ACTIVE COMPARATOR

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; Behavioral: Treatment as usual

Interventions

eFIT Intervention BEHAVIORAL

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

eFIT Behavioral Intervention

eJournal Intervention BEHAVIORAL

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

eJournal Behavioral Intervention

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.

eFIT Behavioral Intervention; eJournal Behavioral Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Diagnosis of multiple sclerosis

You may not qualify if:

• Cannot be available for the next 12 weeks consecutively

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Multiple Sclerosis Clinical Care and Research

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 7823386 BACKGROUND

• 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.

  PMID: 34484928 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Victoria Leavitt, MD

  Assistant Professor of Neuropsychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neuropsychology

Model Details: Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: April 26, 2019
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)