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

NCT07589062 | Not Yet Recruiting

• 1 other identifier: HRPP-2025-268
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

Multiple Sclerosis; Lifestyle Medicine; Exercise Intervention; Lifestyle Intervention; Anti-Inflammatory Diet; Multiomics; Proteomics; Metabolomics; Mitochondrial Dysfunction; Digital Health; Behavioral Change; Fatigue; Neuroinflammation; Lifestyle Diet

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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).

  Baseline to 36 weeks (end of follow-up)

• Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)

  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)

  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)

  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 Outcomes (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

• 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

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

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

Study Arms (1)

HEAL MS Lifestyle Intervention

EXPERIMENTAL

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

Interventions

Multi-Domain Lifestyle Intervention OTHER

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.

HEAL MS Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York University Abu Dhabi: lead

Study Sites (1)

Yas Clinic

Abu Dhabi, United Arab Emirates

Location

Related Publications (5)

• Simpson-Yap S, Nag N, Probst Y, Reece JC, Jelinek GA, Neate S. Prospective associations of better quality of the diet with improved quality of life over 7.5 years in people with multiple sclerosis. Mult Scler Relat Disord. 2022 Apr;60:103710. doi: 10.1016/j.msard.2022.103710. Epub 2022 Feb 21.

  PMID: 35219239 BACKGROUND

• Nauta IM, Loughlin KNM, Gravesteijn AS, van Wegen J, Hofman RP, Wilmsen N, Coles E, van Kempen ZLE, Killestein J, van Oosten BW, Strijbis EMM, Uitdehaag BMJ, de Jong BA. A multi-domain lifestyle intervention in multiple sclerosis: a longitudinal observational study. J Neurol. 2025 Jun 24;272(7):476. doi: 10.1007/s00415-025-13196-9.

  PMID: 40553232 BACKGROUND

• Sanchez JMS, DePaula-Silva AB, Libbey JE, Fujinami RS. Role of diet in regulating the gut microbiota and multiple sclerosis. Clin Immunol. 2022 Feb;235:108379. doi: 10.1016/j.clim.2020.108379. Epub 2020 Mar 7. No abstract available.

  PMID: 32156562 BACKGROUND

• Mannino A, Lithander FE, Dunlop E, Hoare S, Shivappa N, Daly A, Phillips M, Pereira G, Sherriff J, Lucas RM, Ponsonby AL, Hebert JR, van der Mei I, Black LJ; Ausimmune Investigator Group. A proinflammatory diet is associated with an increased likelihood of first clinical diagnosis of central nervous system demyelination in women. Mult Scler Relat Disord. 2022 Jan;57:103428. doi: 10.1016/j.msard.2021.103428. Epub 2021 Nov 24.

  PMID: 34856497 BACKGROUND

• Coe S, Tektonidis TG, Coverdale C, Penny S, Collett J, Chu BTY, Izadi H, Middleton R, Dawes H. A cross sectional assessment of nutrient intake and the association of the inflammatory properties of nutrients and foods with symptom severity in a large cohort from the UK Multiple Sclerosis Registry. Nutr Res. 2021 Jan;85:31-39. doi: 10.1016/j.nutres.2020.11.006. Epub 2020 Nov 20.

  PMID: 33444968 BACKGROUND

Related Links

• Webpage of the New York University Abu Dhabi's Center for Brain and Health, where the original HEAL feasibility study was conducted

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Mitochondrial Diseases; Fatigue; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Study Officials

• Youssef Idaghdour, Professor

  New York University Abu Dhabi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natascha Enriquez, MSc

CONTACT

+971501821961; natasha.enriquez@nyu.edu

Youssef Idaghdour, Professor

CONTACT

+971561845775; yi3@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Data analysis will be conducted using de-identified datasets. Researchers responsible for statistical and multi-omics analyses will receive only coded participant data without access to personal identifiers. This ensures that analysts remain blinded to participant identity during data processing and interpretation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants serve as their own controls in a within-subject interventional study design. The study includes a 12-week observation (control) period during which participants maintain their usual lifestyle, followed by a 12-week lifestyle intervention targeting nutrition, physical activity, sleep, and stress regulation. Assessments are conducted at four timepoints: baseline, after the control period (pre-intervention), post-intervention, and three months after completion of the intervention. This design allows evaluation of biological, functional, and behavioral changes within the same participants over time while reducing inter-individual variability. The intervention is delivered in staggered cohorts to ensure supervision and consistent program delivery.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: May 15, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)