NCT05402501招募中不适用
Lifestyle Intervention for Patients With Multiple Sclerosis
Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Impact Scale (MSIS-29)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Multiple Sclerosis Impact Scale (MSIS-29)
时间窗: Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline.
Questionnaire that measures the impact of MS on their daily functioning
次要结局
- 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.)
- MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT)(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.)
- 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.)
- Hospital Anxiety and Depression Scale (HADS)(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)(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.)
- 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.)
- Medical Consumption Questionnaire (iMCQ)(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.)
- MS sherpa app - Smartphone-adapted two-minute walking test(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.)
- 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.)
- Checklist Individual Strength-20-r (CIS-20)(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)(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)(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))(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)(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(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 - questionnaire(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.)
研究者
Ilse Nauta
Coordinating investigator
Amsterdam UMC, location VUmc
研究点 (1)
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