Lifestyle Intervention for Patients With Multiple Sclerosis (LIMS)

Amsterdam UMC, location VUmc

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Lifestyle intervention program "Leef! met MS"

Study type: Observational

Funder types: Other

Identifiers

NCT05402501

2021.0089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

900 participants in 1 patient group

Patients with multiple sclerosis (MS)

Description:

Patients will participate in an online lifestyle program organized by Voeding Leeft, which consists of four main topics: diet, physical activity, relaxation and sleep.

Treatment:

Behavioral: Lifestyle intervention program "Leef! met MS"