Multiple Sclerosis
Conditions
Keywords
Lifestyle
Brief 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.
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.
Interventions
BEHAVIORALLifestyle intervention program Leef! met MS
The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.
Sponsors
National MS Foundation, The Netherlands
Voeding Leeft
Amsterdam UMC, location VUmc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Impact Scale (MSIS-29) | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. | Questionnaire that measures the impact of MS on their daily functioning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol 5 Dimensions Questionnaire (EQ-5D) | 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. | Questionnaire that measures quality of life |
| BMI | 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 in kg/m\^2 |
| Waist circumference | 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 in centimeters |
| Bristol stool chart | 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. | Tool used to indicate stool type |
| Medical Consumption Questionnaire (iMCQ) | 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. | Questionnaire that measures health-care consumption |
| Hospital Anxiety and Depression Scale (HADS) | 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. | Questionnaire that measures symptoms of depression and anxiety |
| Checklist Individual Strength-20-r (CIS-20) | 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. | Questionnaire that measures the level of fatigue |
| Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P) | 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. | Questionnaire that measures the level of subjective cognitive complaints |
| 12-item Short Form Health Survey (SF-12) | 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. | Questionnaire that measures quality of life |
| Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB)) | 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. | Questionnaire that measures the level of physical activity |
| Perceived stress scale (PSS) | 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. | Questionnaire that measures the level of perceived stress |
| iMTA Productivity Cost Questionnaire (iPCQ) | 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. | Questionnaire that measures work productivity and the frequency of sick leave |
| Neurokeys keyboard app | 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. | Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology. |
| MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT) | 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. | 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. |
| MS sherpa app - Smartphone-adapted two-minute walking test | 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. | Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside. |
| MS sherpa app - questionnaire | 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. | 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. |
| Medical Outcomes Study Sleep Scale (MOS-ss) | 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. | Questionnaire that measures sleep quality |
Countries
Netherlands
Contacts
Primary ContactBrigit de Jong, Dr.
Backup ContactIlse Nauta, Drs.
Outcome results
None listed