Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNew York University Abu Dhabi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Multi-Domain Lifestyle Intervention

    Other intervention

    The intervention is a 12-week multi-domain lifestyle program. It targets four behavioral domains: physical activity, nutrition, sleep, and stress regulation. Participants attend twice-weekly supervised online exercise sessions using scalable functional movements performed with bodyweight, resistance bands, and suspension training. The nutrition component provides individualized meal plans based on maintenance calories, emphasizing anti-inflammatory, whole-food nutrition with a macronutrient distribution of approximately 40% carbohydrates, 30% protein, and 30% fat. During the first two weeks, meals are delivered to support adherence. Sleep optimization focuses on circadian-aligned behaviors such as consistent sleep timing and reduced evening light exposure. Stress regulation includes daily breathing exercises, mindfulness practices, and vagal nerve-stimulating techniques. Participants track dadaily behaviors, wellbeing, and wearable data using a billiungual mobile app.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: HEAL MS Lifestyle InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Rate (Number of Participants Enrolled per Month)

Number of eligible participants enrolled into the study per month, calculated from the number of participants who consent and complete baseline assessment.

Time frame
From study start (Month 0) to completion of recruitment (approximately Month 12)
2

Retention Rate (Percentage of Participants Completing All Study Assessments)

Percentage of enrolled participants who complete all four assessment timepoints (baseline, pre-intervention, post-intervention, and 3-month follow-up).

Time frame
Baseline to 36 weeks (end of follow-up)
3

Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)

Proportion of prescribed exercise sessions attended (twice-weekly supervised sessions) during the 12-week intervention period.

Time frame
Weeks 13-24 (12-week intervention period)
4

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

Average proportion of days participants complete daily logs (including energy, fatigue, mood, sleep, and adherence tracking) via the HEAL MS mobile application.

Time frame
Weeks 13-24 (12-week intervention period)

Secondary outcomes

1

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

CRP will be measured using standard clinical blood chemistry assays. Mean change in CRP concentration will be calculated across timepoints to assess systemic inflammation.

Time frame
Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
2

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

IL-6 will be quantified using proteomic analysis (Olink platform). Mean change across timepoints will be used to assess inflammatory signaling.

Time frame
Baseline (Week 0), Week 12, Week 24, Week 36
3

Change in Plasma Proteomic Profile (Normalized Protein Expression Units)

Quantitative proteomic profiling will be performed using the Olink Reveal platform. A composite score derived from selected proteins related to immune function, oxidative stress, and metabolism will be analyzed using normalized protein expression (NPX) values.

Time frame
Baseline (Week 0), Week 12, Week 24, Week 36
4

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

Metabolomic profiling will be conducted using nuclear magnetic resonance (NMR) spectroscopy, quantifying biomarkers related to lipid metabolism, amino acids, and energy pathways. Mean changes in selected metabolites will be analyzed.

Time frame
Baseline, Week 12, Week 24, Week 36

Other outcomes

Sponsors and contacts

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