Clinical trial NCT05402501: Lifestyle Intervention for Patients With Multiple Sclerosis
Official title: Lifestyle Intervention for Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Lifestyle
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: National MS Foundation, The Netherlands
name: Voeding Leeft
First posted: 2022-06-02
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility 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

Primary outcomes:
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 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:
measure: 12-item Short Form Health Survey (SF-12)
timeFrame: 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.
measure: EuroQol 5 Dimensions Questionnaire (EQ-5D)
timeFrame: 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.
measure: BMI
timeFrame: 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.
measure: Waist circumference
timeFrame: 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.
measure: Bristol stool chart
timeFrame: 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.
measure: Medical Consumption Questionnaire (iMCQ)
timeFrame: 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.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
measure: Checklist Individual Strength-20-r (CIS-20)
timeFrame: 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.
measure: Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P)
timeFrame: 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.
measure: Medical Outcomes Study Sleep Scale (MOS-ss)
timeFrame: 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.
measure: Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB))
timeFrame: 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.
measure: Perceived stress scale (PSS)
timeFrame: 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.
measure: iMTA Productivity Cost Questionnaire (iPCQ)
timeFrame: 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.
measure: Neurokeys keyboard app
timeFrame: 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.
measure: MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)
timeFrame: 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.
measure: MS sherpa app - Smartphone-adapted two-minute walking test
timeFrame: 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.
measure: MS sherpa app - questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Brigit de Jong
role: PRINCIPAL_INVESTIGATOR
References: