Lifestyle Intervention for Patients With Multiple Sclerosis (LIMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Lifestyle intervention program "Leef! met MS"

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.

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Brigit de Jong, Dr.; Phone Number: +31204442834; Email: b.dejong@amsterdamumc.nl
• Study Contact Backup: Name: Ilse Nauta, Drs.; Email: i.nauta1@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Recruiting
      • Amsterdam UMC, location VUmc
      • Contact: Ilse Nauta, Drs.; Email: i.nauta1@amsterdamumc.nl
      • Contact: Brigit de Jong, Dr.; Email: b.dejong@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-item Short Form Health Survey (SF-12)	Questionnaire that measures quality of life	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)	Questionnaire that measures quality of life	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	BMI in kg/m^2	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	Waist circumference in centimeters	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	Tool used to indicate stool type	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.
Medical Consumption Questionnaire (iMCQ)	Questionnaire that measures health-care consumption	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.
Hospital Anxiety and Depression Scale (HADS)	Questionnaire that measures symptoms of depression and anxiety	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.
Checklist Individual Strength-20-r (CIS-20)	Questionnaire that measures the level of fatigue	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.
Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P)	Questionnaire that measures the level of subjective cognitive complaints	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.
Medical Outcomes Study Sleep Scale (MOS-ss)	Questionnaire that measures sleep quality	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.
Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB))	Questionnaire that measures the level of physical activity	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.
Perceived stress scale (PSS)	Questionnaire that measures the level of perceived stress	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.
iMTA Productivity Cost Questionnaire (iPCQ)	Questionnaire that measures work productivity and the frequency of sick leave	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.
Neurokeys keyboard app	Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology.	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.
MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)	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.	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.
MS sherpa app - Smartphone-adapted two-minute walking test	Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside.	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.
MS sherpa app - questionnaire	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.	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.

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: National MS Foundation, The Netherlands; Voeding Leeft
• Investigators: Principal Investigator: Brigit de Jong, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Lifestyle
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2021.0089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No