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临床试验/NCT03829267
NCT03829267已完成不适用

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

Columbia University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Adherence rate: Percentage of weekly eFIT group meetings that participants attend

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 or older
  • •Diagnosis of multiple sclerosis

排除标准

  • •Cannot be available for the next 12 weeks consecutively

研究组 & 干预措施

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.

干预措施: eFIT Intervention (Behavioral)

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.

干预措施: eJournal Intervention (Behavioral)

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.

干预措施: Treatment as usual (Behavioral)

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.

干预措施: Treatment as usual (Behavioral)

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria M. Leavitt

Assistant Professor of Neuropsychology

Columbia University

研究点 (1)

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