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Multiple SclerosisLIMSNCT05402501

Lifestyle Intervention for Patients With Multiple Sclerosis

An observational study of Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Lifestyle intervention program "Leef! met MS"
How many people
900 participants
Where
1 siteNetherlands
Study dates
15 Apr 2021to Nov 2024
Phase
Observational
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with multiple sclerosis (MS) who signed up for the online lifestyle intervention of Voeding Leeft will be asked to participate in this observational study.

Who may be able to join

  • MS diagnosis
  • Motivated to adapt their lifestyle
  • Able to complete online questionnaires by themselves
  • Able to do grocery shopping and to (let someone) prepare the meals from the program
  • In a subpopulation (n=200): daily use of a smartphone

Who cannot join

  • Not able to participate in an online lifestyle intervention (e.g. not having an email address, laptop/computer, internet)
  • An inability to speak or read Dutch
  • Vegan diet
  • Not willing to eat fish
  • BMI <18.5 and >35 kg/m2
  • Pregnant or breastfeeding
Show all 11Show fewer
  • Diagnosis of an eating disorder or psychiatric disorder (according to the DSM-V criteria)
  • History of bariatric surgery
  • Another disorder, such as inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), cardiovascular disease (e.g. severe heart failure), malignancy, diabetes type 1 and 2
  • Having previously participated in a lifestyle intervention of Voeding Leeft or currently participating in another lifestyle program or lifestyle study.
  • Currently under treatment at a dietician or lifestyle coach

Trial locations and contacts

1 site in 1 country.

Brigit de Jong, Dr. contact

+31204442834

b.dejong@amsterdamumc.nl

Ilse Nauta, Drs. contact

i.nauta1@amsterdamumc.nl

Netherlands1 site, 1 recruiting

  • Amsterdam UMC, location VUmc

    Amsterdam, North Holland, 1081 HV

    Brigit de Jong, Dr., b.dejong@amsterdamumc.nl

    Ilse Nauta, Drs., i.nauta1@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.

Read the detailed description

This study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (MS) on daily functioning. MS patients will participate in the online lifestyle intervention of Voeding Leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. A subsample (n=200) will also take part in measurements through mobile applications. The investigators hypothesize that the lifestyle program will reduce the impact of MS on the patients' daily functioning.

Being tested
Lifestyle intervention program "Leef! met MS"
Keywords
Lifestyle
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle intervention program "Leef! met MS"Behavioural

    The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.

Study groups in NCT05402501
Study groupRoleWhat they receive
Patients with multiple sclerosis (MS)Patients will participate in an online lifestyle program organized by Voeding Leeft, which consists of four main topics: diet, physical activity, relaxation and sleep.
Receives: Behavioral: Lifestyle intervention program "Leef! met MS"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multiple Sclerosis Impact Scale (MSIS-29)

    Questionnaire that measures the impact of MS on their daily functioning

    Measured: Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

Secondary outcomes (17)

  1. 12-item Short Form Health Survey (SF-12)

    Questionnaire that measures quality of life

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  2. EuroQol 5 Dimensions Questionnaire (EQ-5D)

    Questionnaire that measures quality of life

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  3. BMI

    BMI in kg/m^2

    Measured: Assessed at 7 time-points during 27 months Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  4. Waist circumference

    Waist circumference in centimeters

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  5. Bristol stool chart

    Tool used to indicate stool type

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  6. Medical Consumption Questionnaire (iMCQ)

    Questionnaire that measures health-care consumption

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  7. Hospital Anxiety and Depression Scale (HADS)

    Questionnaire that measures symptoms of depression and anxiety

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  8. Checklist Individual Strength-20-r (CIS-20)

    Questionnaire that measures the level of fatigue

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  9. Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P)

    Questionnaire that measures the level of subjective cognitive complaints

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  10. Medical Outcomes Study Sleep Scale (MOS-ss)

    Questionnaire that measures sleep quality

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  11. Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB))

    Questionnaire that measures the level of physical activity

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  12. Perceived stress scale (PSS)

    Questionnaire that measures the level of perceived stress

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  13. iMTA Productivity Cost Questionnaire (iPCQ)

    Questionnaire that measures work productivity and the frequency of sick leave

    Measured: Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  14. Neurokeys keyboard app

    Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology.

    Measured: Continuous measures during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  15. MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)

    Only in a subsample (n=200); Patients will use the MS sherpa app to perform a smartphone-adapted Symbol Digit Modalities Test (sSDMT) on their mobile phone.

    Measured: Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  16. MS sherpa app - Smartphone-adapted two-minute walking test

    Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside.

    Measured: Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

  17. MS sherpa app - questionnaire

    Only in a subsample (n=200); Patients will use the MS sherpa app to answer seven questions on a likert-scale (e.g. about pain, stress, energy, memory) within the mobile application.

    Measured: Weekly questionnaire during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start15 Apr 2021
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05402501
Sponsor's protocol ID
2021.0089
Acronym
LIMS
Status last verified
May 2022
First submitted
19 Apr 2022
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gravesteijn AS, Nauta IM, Stob M, Wilmsen N, Coles E, de Groot V, E van Kempen ZL, Killestein J, Van Oosten BW, Strijbis EM, Uitdehaag BMJ, de Jong BA. Sustained Benefits of a Multidomain Lifestyle Intervention in Multiple Sclerosis in the LIMS Study: A 24-Month Follow-Up. Neurology. 2026 Oct 27;107(8):e218542. doi: 10.1212/WNL.0000000000218542. Epub 2026 Sep 24.

    PubMed 42784777

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brigit de Jong, Dr. (+31204442834, b.dejong@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multiple Sclerosis Impact Scale (MSIS-29) (time frame: Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.). 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 NCT05402501, which also lists 1 linked publication.

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 2 Jun 2022.

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