<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03829267</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4052-2</org_study_id>
    <nct_id>NCT03829267</nct_id>
  </id_info>
  <brief_title>eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With MS</brief_title>
  <acronym>eFIT</acronym>
  <official_title>eFIT: An Internet-based Intervention to Increase Physical Activity in Persons With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      eFIT is a technology-enabled internet based psychosocial intervention to increase physical&#xD;
      activity in persons with multiple sclerosis, who are at unique risk for sedentary behaviors&#xD;
      and for whom exercise and physical activity hold many benefits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial of an internet-based intervention to increase physical&#xD;
      activity in persons with multiple sclerosis. Multiple sclerosis (MS) is the most common&#xD;
      non-traumatic neurological cause of disability in young adults. Sedentary behavior, now&#xD;
      recognized as a major contributor to increased morbidity is seen at higher rates and related&#xD;
      to adverse health outcomes for persons with MS (PwMS). Prominent symptoms of MS (motor&#xD;
      impairment, fatigue, depressed mood, pain), place this population at unique risk for&#xD;
      increased sedentary behavior. And importantly, with increased age comes increased risk:&#xD;
      patients over 60 are significantly more sedentary than middle-aged patients. On a positive&#xD;
      note, current disease modifying therapies prolong time to disease progression, widening the&#xD;
      window of opportunity for implementing behavioral interventions that support health and&#xD;
      successful aging. Behaviors adopted early in life are more likely to be maintained into later&#xD;
      adulthood. Physical activity is beneficial for PwMS on multiple levels: improved gait and&#xD;
      balance, improved cognition, reduced depression and fatigue. Finding ways to increase&#xD;
      physical activity is a key research priority for MS. Behavioral change is difficult to adopt&#xD;
      and even more difficult to maintain. Here, we introduce a novel behavioral intervention to&#xD;
      increase physical activity, eFIT, a technology-enabled (i.e., internet-delivered) support&#xD;
      group-based treatment that leverages accountability to motivate and sustain behavioral&#xD;
      change. Accountability constitutes the bedrock underlying the single most pervasive,&#xD;
      successful, and widely embraced behavioral intervention known: Alcoholics Anonymous (AA).&#xD;
      Through sponsors and support groups, AA utilizes accountability partners to deliver,&#xD;
      reinforce, and sustain life-saving behavioral change. Here, we leverage accountability&#xD;
      partners to motivate enduring behavioral change in physical activity participation, one of&#xD;
      the single most difficult health behaviors to implement and maintain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2019</start_date>
  <completion_date type="Actual">April 13, 2020</completion_date>
  <primary_completion_date type="Actual">April 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence rate: Percentage of weekly eFIT group meetings that participants attend</measure>
    <time_frame>12-weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion rate: Percentage of enrolled participants who complete follow-up questionnaires</measure>
    <time_frame>12-weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)</measure>
    <time_frame>12-weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>12-weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UCLA Loneliness Scale</measure>
    <time_frame>12-weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>eFIT Behavioral Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eJournal Behavioral Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eFIT Intervention</intervention_name>
    <description>eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis</description>
    <arm_group_label>eFIT Behavioral Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eJournal Intervention</intervention_name>
    <description>1-hour online each week engaged in an active journaling activity</description>
    <arm_group_label>eJournal Behavioral Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>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.</description>
    <arm_group_label>eFIT Behavioral Intervention</arm_group_label>
    <arm_group_label>eJournal Behavioral Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot be available for the next 12 weeks consecutively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Leavitt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Neuropsychology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Multiple Sclerosis Clinical Care and Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>7823386</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Victoria M. Leavitt</investigator_full_name>
    <investigator_title>Assistant Professor of Neuropsychology</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03829267
org study id: AAAR4052-2
nct id: NCT03829267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to (a) SNAP treatment, (b) active control condition (eJournaling), or (c) waitlist control
primary purpose: Treatment
masking: Single (Investigator)
masking description: 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.
measure: Adherence rate: Percentage of weekly eFIT group meetings that participants attend
time frame: 12-weeks
description: 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
measure: Completion rate: Percentage of enrolled participants who complete follow-up questionnaires
time frame: 12-weeks
description: 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.
measure: Change in International Physical Activity Questionnaire (IPAQ) total score (self-reported physical activity level)
time frame: 12-weeks
description: 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.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: 12-weeks
description: 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.
measure: UCLA Loneliness Scale
time frame: 12-weeks
description: 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.
arm group label: eFIT Behavioral Intervention
arm group type: Experimental
description: 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.
arm group label: eJournal Behavioral Intervention
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: eFIT Intervention
description: eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis
arm group label: eFIT Behavioral Intervention
intervention type: Behavioral
intervention name: eJournal Intervention
description: 1-hour online each week engaged in an active journaling activity
arm group label: eJournal Behavioral Intervention
intervention type: Behavioral
intervention name: Treatment as usual
description: 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.
arm group label: eFIT Behavioral Intervention
arm group label: eJournal Behavioral Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victoria Leavitt, MD
role: Principal Investigator
affiliation: Assistant Professor of Neuropsychology
facility: 
country: United States
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.
PMID: 7823386
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Victoria M. Leavitt
investigator title: Assistant Professor of Neuropsychology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No