Lifestyle Intervention for Patients With Multiple Sclerosis

NCT ID: NCT05402501

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-11-30

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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lifestyle intervention program "Leef! met MS"

Intervention Type BEHAVIORAL

The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings.

Interventions

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Lifestyle 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National MS Foundation, The Netherlands

UNKNOWN

Sponsor Role collaborator

Voeding Leeft

UNKNOWN

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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Ilse Nauta

Coordinating investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brigit de Jong

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Brigit de Jong, Dr.

Role: CONTACT

+31204442834

Ilse Nauta, Drs.

Role: CONTACT

Facility Contacts

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Brigit de Jong, Dr.

Role: primary

Ilse Nauta, Drs.

Role: backup

Other Identifiers

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2021.0089

Identifier Type: -

Identifier Source: org_study_id

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