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

May 8, 2026 updated by: New York University Abu Dhabi

HEAL MS: A Culturally Adapted Lifestyle Medicine Intervention Targeting Metabolic and Immune Dysregulation in Multiple Sclerosis Using Multi-Omics Profiling

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system characterized by neurodegeneration, demyelination, and progressive disability. Although current treatments primarily focus on immune suppression, growing evidence indicates that non-immune mechanisms, including mitochondrial dysfunction, metabolic imbalance, and chronic systemic inflammation, play a significant role in disease progression and symptom burden. Multi-omics studies have identified disruptions in mitochondrial proteins, lipid and amino acid metabolism, and inflammatory signaling pathways in individuals with MS, suggesting that systemic metabolic processes contribute to disease activity and may represent modifiable therapeutic targets.

HEAL MS (Healthy Eating and Active Living for Multiple Sclerosis) was developed to address these upstream biological drivers through a structured lifestyle intervention integrating nutrition, physical activity, sleep optimization, and stress regulation. The program is culturally adapted for the UAE population and delivered through a hybrid model combining in-person onboarding and digital support via a bilingual (Arabic-English) mobile application that facilitates behavioral tracking, education, and participant engagement.

This study is a 24-month pilot interventional study designed to evaluate the feasibility, acceptability, and biological impact of the HEAL MS program in individuals with relapsing-remitting or progressive MS. Thirty participants will be recruited from collaborating MS clinics. The study uses a within-subject design consisting of a 12-week observation (control) period followed by a 12-week lifestyle intervention. Assessments are conducted at four timepoints: baseline, pre-intervention, post-intervention, and three months after completion of the intervention. This design allows each participant to serve as their own control, improving statistical sensitivity and reducing inter-individual variability.

The intervention targets four behavioral domains. Adaptive movement training consists of supervised small-group sessions conducted twice weekly using functional resistance exercises based on bodyweight, resistance bands, and suspension training. Exercises are designed to improve strength, neuromuscular coordination, and mitochondrial resilience while remaining scalable to accommodate MS-related fatigue and mobility limitations. The nutrition component emphasizes anti-inflammatory, nutrient-dense whole foods with a macronutrient distribution of approximately 40% carbohydrates, 30% protein, and 30% fat. Personalized calorie targets are calculated using the Mifflin-St Jeor equation, and participants receive meal delivery during the initial two weeks to facilitate adherence before transitioning to guided self-preparation. Sleep optimization focuses on circadian-aligned behavioral strategies such as consistent sleep schedules, screen-light reduction, and timing of meals and exercise. Stress regulation includes daily breath-based practices, mindfulness exercises, and vagal nerve-stimulating techniques designed to support autonomic balance. Participant engagement and adherence are supported through daily behavioral tracking using the mobile application.

The study integrates biological, clinical, and behavioral outcomes to evaluate the mechanistic impact of the intervention. Blood samples collected at each assessment will undergo routine clinical chemistry testing and high-resolution molecular profiling. Proteomic analysis will be performed using the Olink Reveal platform, enabling multiplex quantification of over 1,000 plasma proteins related to immune signaling, inflammation, oxidative stress, and metabolic regulation. Metabolomic profiling will be conducted using nuclear magnetic resonance spectroscopy to quantify approximately 250 circulating metabolic biomarkers related to mitochondrial function and systemic metabolism.

Additional outcome measures include body composition assessment using multi-frequency bioelectrical impedance analysis, validated functional performance tests (6-minute step test, five-times-sit-to-stand test, and grip strength), and psychometric instruments assessing fatigue, mood, sleep quality, cognitive performance, and quality of life. Wearable monitoring devices will be used to capture sleep duration, activity levels, and heart rate variability as indicators of physiological recovery and autonomic regulation.

By integrating behavioral intervention with high-resolution molecular profiling, HEAL MS aims to generate mechanistic insight into how lifestyle modification influences metabolic, inflammatory, and mitochondrial pathways in MS. Findings from this pilot study will inform the feasibility and design of larger randomized trials investigating lifestyle-based strategies as complementary approaches to disease management.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Youssef Idaghdour, Professor
  • Phone Number: +971561845775
  • Email: yi3@nyu.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEAL MS Lifestyle Intervention
Participants first complete a 12-week observation period during which they maintain their usual lifestyle. This is followed by a 12-week HEAL MS lifestyle intervention targeting four domains: adaptive movement, anti-inflammatory nutrition, sleep optimization, and stress regulation. The movement component includes twice-weekly supervised online group exercise sessions using scalable functional exercises. The nutrition component provides personalized meal plans with two weeks of meal delivery to support adherence. Sleep and stress modules include circadian hygiene strategies, breathwork, and mindfulness practices. Participants track daily behaviors, wellbeing, and optional wearable data through a bilingual mobile application. Assessments including blood sampling, body composition, functional fitness testing, and questionnaires are conducted at baseline, pre-intervention, post-intervention, and three months post-intervention.
Other: Multi-Domain Lifestyle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate (Number of Participants Enrolled per Month)
Time Frame: From study start (Month 0) to completion of recruitment (approximately Month 12)
Number of eligible participants enrolled into the study per month, calculated from the number of participants who consent and complete baseline assessment.
From study start (Month 0) to completion of recruitment (approximately Month 12)
Retention Rate (Percentage of Participants Completing All Study Assessments)
Time Frame: Baseline to 36 weeks (end of follow-up)
Percentage of enrolled participants who complete all four assessment timepoints (baseline, pre-intervention, post-intervention, and 3-month follow-up).
Baseline to 36 weeks (end of follow-up)
Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)
Time Frame: Weeks 13-24 (12-week intervention period)
Proportion of prescribed exercise sessions attended (twice-weekly supervised sessions) during the 12-week intervention period.
Weeks 13-24 (12-week intervention period)
Mobile Application Engagement (Average Daily Completion Rate of App-Based Logs)
Time Frame: Weeks 13-24 (12-week intervention period)
Average proportion of days participants complete daily logs (including energy, fatigue, mood, sleep, and adherence tracking) via the HEAL MS mobile application.
Weeks 13-24 (12-week intervention period)
Acceptability of HEAL MS Intervention (Participant Satisfaction Score)
Time Frame: Week 24 (post-intervention assessment)
Participant-reported satisfaction with the intervention, assessed using a standardized post-intervention questionnaire (e.g., Likert scale rating of overall experience, usability, and perceived benefit).
Week 24 (post-intervention assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Plasma C-Reactive Protein (CRP) Concentration (mg/L)
Time Frame: Baseline (Week 0), Pre-Intervention (Week 12), Post-Intervention (Week 24), and Follow-up (Week 36)
CRP will be measured using standard clinical blood chemistry assays. Mean change in CRP concentration will be calculated across timepoints to assess systemic inflammation.
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)
Time Frame: Baseline (Week 0), Week 12, Week 24, Week 36
IL-6 will be quantified using proteomic analysis (Olink platform). Mean change across timepoints will be used to assess inflammatory signaling.
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Plasma Proteomic Profile (Normalized Protein Expression Units)
Time Frame: Baseline (Week 0), Week 12, Week 24, Week 36
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.
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)
Time Frame: Baseline, Week 12, Week 24, Week 36
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.
Baseline, Week 12, Week 24, Week 36
Change in Perceived Stress Score (Perceived Stress Scale, PSS-10)
Time Frame: Baseline (Week 0), Week 12, Week 24, Week 36
Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10), a validated measure of perceived stress over the past month (score range: 0-40; higher scores indicate greater perceived stress).
Baseline (Week 0), Week 12, Week 24, Week 36
Change in Daily Emotional Wellbeing Score (App-Based Self-Assessment)
Time Frame: Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)
Emotional wellbeing will be assessed using a daily app-based self-report measure (mood and emotional state), collected using a visual Likert or pictorial (Self-Assessment Manikin-style) scale. Scores will be averaged over 7-day periods prior to each assessment timepoint (range: 0-4; higher scores indicate worse wellbeing).
Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University Abu Dhabi

Investigators

  • Principal Investigator: Youssef Idaghdour, Professor, New York University Abu Dhabi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRPP-2025-268

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified IPD may be shared upon reasonable request, subject to institutional approvals and data protection regulations. All shared data will be fully anonymized to protect participant confidentiality. Due to the sensitive nature of multi-omics and health-related data, access may be restricted and governed by data use agreements to ensure compliance with ethical and regulatory standards.

Study Data/Documents

  1. Study Protocol
    Information comments: Original Grant Application

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Multi-Domain Lifestyle Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe