MSFrontier

HEAL-MS

HEAL MS: A Culturally Adapted Lifestyle Medicine Intervention Targeting Metabolic and Immune Dysregulation in Multiple Sclerosis Using Multi-Omics Profiling
Not yet recruitingNot a drug-phase studyRelapsing MSNCT07589062

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Multi-Domain Lifestyle Intervention

What it measured

Main measures

  • Recruitment Rate (Number of Participants Enrolled per Month)

    From study start (Month 0) to completion of recruitment (approximately Month 12)

    Feasibility

  • Retention Rate (Percentage of Participants Completing All Study Assessments)

    Baseline to 36 weeks (end of follow-up)

    Feasibility

  • Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)

    Weeks 13-24 (12-week intervention period)

    Physical functionQuality of life (reported by participants)

  • Mobile Application Engagement (Average Daily Completion Rate of App-Based Logs)

    Weeks 13-24 (12-week intervention period)

    FatigueMood and sleepQuality of life (reported by participants)

  • Acceptability of HEAL MS Intervention (Participant Satisfaction Score)

    Week 24 (post-intervention assessment)

    Quality of life (reported by participants)Feasibility

Other measures (6)

  • Change in Plasma C-Reactive Protein (CRP) Concentration (mg/L)

    Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)

  • Change in Plasma Interleukin-6 (IL-6) Levels (pg/mL)

    Baseline (Week 0), Week 12, Week 24, Week 36

    Immune response

  • Change in Plasma Proteomic Profile (Normalized Protein Expression Units)

    Baseline (Week 0), Week 12, Week 24, Week 36

  • Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)

    Baseline, Week 12, Week 24, Week 36

    MRI lesionsBlood or spinal fluid markers

  • Change in Perceived Stress Score (Perceived Stress Scale, PSS-10)

    Baseline (Week 0), Week 12, Week 24, Week 36

  • Change in Daily Emotional Wellbeing Score (App-Based Self-Assessment)

    Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)

    Mood and sleep

Who could take part

Relapsing MS · 18 to 50

Inclusion Criteria: * Confirmed MS diagnosis (McDonald criteria) * EDSS score ≤ 6.5 (i.e., ambulatory with or without assistance) * Stable disease-modifying therapy for ≥ 3 months * Age 18-50 * Proficiency in English or Arabic * Clearance to participate in a structured exercise program * Ability to walk, sit and stand independently, and perform light-to-moderate movement patterns, even with modifications * Ability and digital literacy to interact with the bilingual HEAL MS mobile app and * Access to a computer for participation in online sessions Exclusion Criteria: * Significant cognitive impairment affecting app use and comprehension of the intervention * MS relapse within the past 3 months * Pregnancy or planned pregnancy * Unmanaged psychiatric disorders * Other immune-related or chronic inflammatory or metabolic diseases * Concurrent enrollment in another lifestyle intervention

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The goal of this clinical trial is to learn whether a structured lifestyle program can improve health and wellbeing in people living with multiple sclerosis (MS). The program focuses on four areas: nutrition, physical activity, sleep, and stress management. The study will also examine how lifestyle changes affect biological markers related to inflammation, metabolism, and immune function. The main questions the study aims to answer are: Can a 12-week lifestyle program improve fatigue, physical function, sleep, and quality of life in people with MS? Do lifestyle changes influence biological markers related to inflammation, metabolism, and mitochondrial function? Participants will first complete a 12-week observation period to measure their usual lifestyle and health. After this, they will take part in the 12-week HEAL MS lifestyle program. Participants will: Attend four assessment visits at Yas Clinic (baseline, before the intervention, after the intervention, and three months later) Participate in two supervised online exercise sessions per week during the 12-week program Follow a structured nutrition plan, with meals provided during the first two weeks Use a mobile application to log daily habits related to exercise, nutrition, sleep, and stress Complete questionnaires and physical tests and provide blood, saliva, and stool samples during assessment visits Researchers will analyze these data to understand whether lifestyle interventions can support symptom management and overall health in people living with MS.

Papers

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History

    1. Started

      Apr 2026

    2. Main results due

      Nov 2027

    3. Finished

      Nov 2027

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