Multiple Sclerosis (MS) - Relapsing-remittingHEAL-MSNCT07589062
Healthy Eating and Active Living for People Living With Multiple Sclerosis (HEAL MS): A Lifestyle Program for People With Multiple Sclerosis
A study testing Multi-Domain Lifestyle Intervention in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis, run by New York University Abu Dhabi at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis
- What is being tested?
- Multi-Domain Lifestyle Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Apr 2026to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
Yas Clinic
Abu Dhabi
Lev Brylev, MD, PhD, +971502377993, lev.brylev@adscc.ae
Ruqqia Mir, MD, +971553676270, ruqqia.m@adscc.ae
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Multi-Domain Lifestyle Intervention
- 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
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Mitochondrial Diseases, Fatigue, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Domain Lifestyle InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multi-Domain Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 24 (post-intervention assessment)
Secondary outcomes (6)
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.
Measured: 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)
IL-6 will be quantified using proteomic analysis (Olink platform). Mean change across timepoints will be used to assess inflammatory signaling.
Measured: Baseline (Week 0), Week 12, Week 24, Week 36
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.
Measured: Baseline (Week 0), Week 12, Week 24, Week 36
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.
Measured: Baseline, Week 12, Week 24, Week 36
Change in Perceived Stress Score (Perceived Stress Scale, PSS-10)
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).
Measured: Baseline (Week 0), Week 12, Week 24, Week 36
Change in Daily Emotional Wellbeing Score (App-Based Self-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).
Measured: Weeks 0, 12, 24, and 36 (7-day averages prior to each assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University Abu Dhabi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef Idaghdour, Professor, Principal investigator, New York University Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589062
- Sponsor's protocol ID
- HRPP-2025-268
- Acronym
- HEAL-MS
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35219239Nauta 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.
PubMed 40553232Sanchez 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.
PubMed 32156562Mannino 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.
PubMed 34856497Coe 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.
PubMed 33444968
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAL MS: A Culturally Adapted Lifestyle Medicine Intervention Targeting Metabolic and Immune Dysregulation in Multiple Sclerosis Using Multi-Omics Profiling
- ClinicalTrials.gov ID
- NCT07589062
- Acronym / sponsor ID
- HEAL-MS / HRPP-2025-268
- Keywords
- Multiple Sclerosis, Lifestyle Medicine, Exercise Intervention, Lifestyle Intervention, Anti-Inflammatory Diet, Multiomics, Proteomics, Metabolomics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York University Abu DhabiUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEAL MS Lifestyle Intervention | Experimental | Other: Multi-Domain Lifestyle InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Domain Lifestyle InterventionThe 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. | Other | HEAL MS Lifestyle Intervention |
Primary outcome
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.
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).
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.
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.
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).
6 secondary outcomes
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)
Change in Plasma Interleukin-6 (IL-6) Levels (pg/mL)
Time frame: 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
Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)
Time frame: 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 35219239Simpson-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.
- Background: PubMed 40553232Nauta 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.
- Background: PubMed 32156562Sanchez 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.
- Background: PubMed 34856497Mannino 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.
- Background: PubMed 33444968Coe 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.
- Webpage of the New York University Abu Dhabi's Center for Brain and Health, where the original HEAL feasibility study was conductedLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youssef Idaghdour, Professor principal investigator
New York University Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Domain Lifestyle Intervention in people with Multiple Sclerosis (MS) - Relapsing-remitting and Multiple Sclerosis, run by New York University Abu Dhabi at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natascha Enriquez, MSc (+971501821961, natasha.enriquez@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (Number of Participants Enrolled per Month) (time frame: From study start (Month 0) to completion of recruitment (approximately Month 12)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589062, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.