Lifestyle Intervention for Patients With Multiple Sclerosis
LIMS
1 other identifier
observational
900
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedJune 2, 2022
May 1, 2022
3.6 years
April 19, 2022
May 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
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.
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.
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.
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.
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.
- +12 more secondary outcomes
Study Arms (1)
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.
Interventions
The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- National MS Foundation, The Netherlandscollaborator
- Voeding Leeftcollaborator
Study Sites (1)
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigit de Jong
Amsterdam UMC, location VUmc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinating investigator
Study Record Dates
First Submitted
April 19, 2022
First Posted
June 2, 2022
Study Start
April 15, 2021
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
June 2, 2022
Record last verified: 2022-05