Primary Results of a Phase-III, Randomized Controlled Trial of the Behavioral Intervention for Increasing Physical Activity in Multiple Sclerosis Project

Document Type

Article

Publication Date

3-2023

Publisher

SAGE

Source Publication

Multiple Sclerosis Journal

Source ISSN

1352-4585

Original Item ID

DOI: 10.1177/13524585221146430

Abstract

Background

We undertook a phase-III, randomized controlled trial (RCT) that examined the effectiveness of a behavioral intervention based on social cognitive theory (SCT) and delivered through the Internet using e-learning approaches for immediate and sustained increases in physical activity among persons with multiple sclerosis (MS).

Method

The study followed a parallel group RCT design. Persons with MS (N = 318) were randomized into either behavioral intervention (n = 159) or attention/social contact control (n = 159) conditions. The conditions were administered over a 6-month period by persons who were uninvolved in screening, recruitment, random assignment, and outcome assessment. There was a 6-month follow-up period without access of conditions. We collected outcome data every 6 months over the 12-month period. The primary outcome was device-measured minutes/day of moderate-to-vigorous physical activity (MVPA). The data analysis involved a modified intent-to-treat approach (i.e. those who received the allocated conditions) using a linear mixed model.

Results

There was a significant group by time interaction on the primary outcome of device-measured minutes/day of MVPA (p < 0.005). MVPA was increased immediately after the 6-month period in the behavioral intervention compared with control, and this difference was sustained over the 6-month follow-up.

Conclusion

This study provides evidence for the effectiveness of a widely scalable approach for increasing MVPA in persons with MS.

Comments

Multiple Sclerosis Journal, Vol. 29, No. 3 (March 2023): 415-426. DOI.

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