Patient-Centered, Theory-Based, Online Intervention to Promote a Physically Active Lifestyle for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: People with multiple sclerosis (MS) experience life challenges due to the nature of disease progression. Although an active lifestyle has been shown effective for symptom and relapse management, most people with MS lead a sedentary lifestyle and do not reach the recommended physical activity (PA) guidelines. OBJECTIVE: This study aims to test the preliminary efficacy of a codeveloped, online self-management intervention based on the health action process approach (HAPA) adapted for people with MS to cultivate a physically active lifestyle. METHODS: The 8-week intervention program was developed using community-based participatory research based on the HAPA. The program includes increasing awareness of incorporating PA in a daily routine, the benefits of physical activities for people with MS, developing motivation, utilizing social and environmental support, setting measurable goals and doable plans, and coping with barriers for long-term adoption of new behaviors. Community members with MS serve as peer coaches. We aimed to recruit 60 people with MS, randomizing them to an intervention group or a wait-list control group. Control group participants do not receive any intervention nor information for the period of study. Participants will complete PA measures (accelerometer and survey) and psychological assessments at baseline; after an 8-week intervention; and 3 months, 6 months, and 12 months postintervention. We hypothesize that the intervention group will have (1) higher scores on the HAPA questionnaires and (2) higher frequency, duration, and intensity of engagement in PA after the intervention than the control group. We will conduct descriptive analyses (means, SDs), chi-squared tests, independent t tests, paired t tests, repeated measures ANOVA, and 2-way (any 2 factors of conditions, disability severity levels, and time) and 3-way (conditions × disability severity levels × time) mixed model ANOVAs. RESULTS: The study was funded in April 2018 and was delayed due to the COVID-19 pandemic. We invited peer coaches to review the accessibility of online modules in fall 2022. We finalized the module accessibility and trained peer coaches on how to use the online modules in December 2022. Since February 2023, we have recruited 50 participants to the trial who have been assigned to the intervention group (n=25) or control group (n=25). During the follow-up stage, 3 participants dropped out of the intervention group, and 4 participants dropped out of the control group. Enrollment ended in 2024, and data collection is expected to conclude by December 2025, with results anticipated to be published in January 2026. CONCLUSIONS: This study will test the effectiveness of using an evidence-based online intervention for self-management of physical activity behavior by people with MS. The results of the study will provide us with insightful information for designing community-based participatory research and implementing telerehabilitation interventions for people with MS. TRIAL REGISTRATION: ClinicalTrials.gov NCT05124522; https://clinicaltrials.gov/study/NCT05124522. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66091.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.024 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.005 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.008 | 0.009 |
| Insufficient payload (model declined to judge) | 0.081 | 0.012 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".