Lifestyle Intervention for Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— LIMS  

Official title:

Lifestyle Intervention for Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402501
• Other study ID #: 2021.0089
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: November 2024

Study information

• Verified date: May 2022
• Source: Amsterdam UMC, location VUmc
• Contact: Brigit de Jong, Dr.
• Phone: +31204442834
• Email: b.dejong[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	National MS Foundation, The Netherlands, Voeding Leeft

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.