Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

Summary

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

BIPAMS

The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention. Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program. The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.

BEHAVIORAL

WELLMS

The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Donald Lein, PhD · Associate Professor

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2023-03-01

Completion

2026-12-31

Countries

• United States

Study Locations