Multiple SclerosiseFITNCT03829267
eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With MS
A study testing eFIT Intervention, eJournal Intervention and Treatment as usual in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- eFIT Intervention, eJournal Intervention and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosis of multiple sclerosis
Who cannot join
- Cannot be available for the next 12 weeks consecutively
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Multiple Sclerosis Clinical Care and Research
New York, New York, 10032
About this study
Official title: eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis
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.
Read the 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
- Being tested
- eFIT Intervention, eJournal Intervention, Treatment as usual
- Keywords
- exercise, physical activity
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFIT InterventionBehavioural
eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis
eJournal InterventionBehavioural
1-hour online each week engaged in an active journaling activity
Treatment as usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: eJournal Intervention; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12-weeks
Secondary outcomes (3)
Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)
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.
Measured: 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 12-weeks
UCLA Loneliness Scale
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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start26 Apr 2019
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria M. Leavitt, Columbia University
- Investigators
- Victoria Leavitt, MD, Principal investigator, Assistant Professor of Neuropsychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829267
- Sponsor's protocol ID
- AAAR4052-2
- Acronym
- eFIT
- Status last verified
- Nov 2020
- First submitted
- 1 Feb 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7823386Leavitt 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.
PubMed 34484928
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03829267
- Acronym / sponsor ID
- eFIT / AAAR4052-2
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
| Arm | Type | Receives |
|---|---|---|
| eFIT Behavioral Intervention | Experimental | Behavioral: eFIT Intervention, Behavioral: Treatment as usualIntervention: 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 | Active comparator | Behavioral: eJournal Intervention, Behavioral: Treatment as usualIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Diagnosis of multiple sclerosis
Key exclusion criteria (1 listed)
- Cannot be available for the next 12 weeks consecutively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eFIT InterventioneFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis | Behavioural | eFIT Behavioral Intervention |
| eJournal Intervention1-hour online each week engaged in an active journaling activity | Behavioural | eJournal Behavioral Intervention |
| Treatment as usualParticipants 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. | Behavioural | eFIT Behavioral Intervention, eJournal Behavioral Intervention |
Primary outcome
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
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.
3 secondary outcomes
Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)
Time frame: 12-weeks
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12-weeks
UCLA Loneliness Scale
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 7823386Pate 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.
- Derived from this study: PubMed 34484928Leavitt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Leavitt, MD principal investigator
Assistant Professor of Neuropsychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eFIT Intervention, eJournal Intervention and Treatment as usual in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate: Percentage of weekly eFIT group meetings that participants attend (time frame: 12-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829267, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 29 Oct 2026.