Lifestyle Intervention for Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lifestyle Intervention for Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Lifestyle intervention program Leef! met MS


Participation Criteria
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Eligibility Criteria
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Eligibility criteria to participate in the online lifestyle intervention: Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with multiple sclerosis (MS)<br>Patients will participate in an online lifestyle program organized by Voeding Leeft, which consists of four main topics: diet, physical activity, relaxation and sleep. | Behavioral: Lifestyle intervention program Leef! met MS<br>* The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Sclerosis Impact Scale (MSIS-29) | Questionnaire that measures the impact of MS on their daily functioning | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-item Short Form Health Survey (SF-12) | Questionnaire that measures quality of life | 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. | 
| EuroQol 5 Dimensions Questionnaire (EQ-5D) | Questionnaire that measures quality of life | 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. | 
| BMI | BMI in kg/m^2 | 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. | 
| Waist circumference | Waist circumference in centimeters | 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. | 
| Bristol stool chart | Tool used to indicate stool type | 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. | 
| Medical Consumption Questionnaire (iMCQ) | Questionnaire that measures health-care consumption | 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. | 
| Hospital Anxiety and Depression Scale (HADS) | Questionnaire that measures symptoms of depression and anxiety | 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. | 
| Checklist Individual Strength-20-r (CIS-20) | Questionnaire that measures the level of fatigue | 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. | 
| Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P) | Questionnaire that measures the level of subjective cognitive complaints | 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. | 
| Medical Outcomes Study Sleep Scale (MOS-ss) | Questionnaire that measures sleep quality | 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. | 
| Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB)) | Questionnaire that measures the level of physical activity | 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. | 
| Perceived stress scale (PSS) | Questionnaire that measures the level of perceived stress | 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. | 
| iMTA Productivity Cost Questionnaire (iPCQ) | Questionnaire that measures work productivity and the frequency of sick leave | 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. | 
| Neurokeys keyboard app | Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology. | 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. | 
| 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. | 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. | 
| 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. | 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. | 
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyle