The LifeMeds Cohort: Joining Forces to Assess (Determinants of) Lifestyle Behavior, Morbidity and Mortality Among Multimorbid Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 主要终点
- Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).
研究概览
简要总结
The goal of this observational study is to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in adults with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases, including cardiovascular disease, type 2 diabetes, chronic respiratory disease, and/or cancer. The main questions it aims to answer are:
- What lifestyle trajectories can be identified over time in individuals with multimorbidity, how do these trajectories differ across multimorbidity profiles, and which psychological, social, and sociodemographic factors are associated with these trajectories?
- How are lifestyle trajectories associated with morbidity, mortality, health-related quality of life, and other major health outcomes over time?
Participants will complete one annual questionnaire during a follow-up period of ten years.
详细描述
Background and Rationale:
Multimorbidity, commonly defined as the coexistence of two or more chronic diseases, is an increasing public health challenge associated with reduced quality of life, increased healthcare utilization, and premature mortality. Lifestyle behaviours, including physical activity, diet, smoking, alcohol consumption, sleep, and medication adherence, play an important role in the prevention and management of many chronic diseases. Although lifestyle interventions have been developed and evaluated for individual chronic diseases, considerably less is known about lifestyle behaviour patterns, their determinants, and effective lifestyle support strategies among individuals living with multimorbidity. The coexistence of multiple chronic conditions may introduce unique barriers and facilitators to lifestyle modification that are not adequately captured in single-disease research. Therefore, the LifeMeds cohort was established to investigate lifestyle behaviours, their determinants, and their associations with health outcomes in individuals with multimorbidity over time.
Aims and Objectives:
Aim 1: To longitudinally identify lifestyle behaviours and their determinants in individuals with multimorbidity.
- Objective 1a. To investigate lifestyle trajectories of individuals with multimorbidity and to identify potential similarities and differences in lifestyle trajectories between individuals with different combinations of multimorbidity.
- Objective 1b. To identify determinants of lifestyle behaviours in individuals with multimorbidity and monitor changes over time.
- Objective 1c. To link different lifestyle trajectories to future morbidity and mortality risk.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with two or more of the following diseases: type 2 diabetes, cancer, cardiovascular disease and/or chronic respiratory diseases.
- •Aged 18 years or older
排除标准
- •Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)
研究组 & 干预措施
Multimorbid individuals
Individuals who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory diseases and/or cancer.
结局指标
主要结局
Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).
时间窗: From enrollment to the end of the study at 10 years
The SQUASH is a validated questionnaire that assesses habitual physical activity across commuting, household, leisure-time, and occupational domains. Repeated assessments over time will enable the evaluation of changes in physical activity levels.
Changes in dietary intake using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI).
时间窗: From enrollment to the end of the study at 10 years
Dietary intake is assessed using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI). The questionnaire captures key aspects of diet quality and adherence to dietary recommendations. Repeated assessments over time will enable the evaluation of changes in dietary behaviours.
Changes in alcohol consumption using a self-composed questionnaire.
时间窗: From enrollment until the end of the study at 10 years
Participants will first be asked whether they consume alcohol. Those who do will be asked to report their average weekly intake, specified in number of glasses, across four predefined categories of alcoholic beverages: beer, craft beer, wine, aperitifs, and spirits.
Changes in smoking habits using self-composed items combined with the Fagerström Test for Nicotine Dependence (FTND).
时间窗: From enrollment until the end of the study at 10 years
Participants will first complete a set of self-developed questions assessing current smoking status ("never smoked", "former smoker" with years since cessation, or "current smoker"). Current smokers will additionally report the number of cigarettes smoked per day and the age at which they started smoking. In addition, participants who indicate that they currently smoke will subsequently complete the FTND, a validated six-item questionnaire that assesses the intensity of physical nicotine dependence. Longitudinal assessment will allow the evaluation of changes in smoking habits.
Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) score.
时间窗: From enrollment until the end of the study at 10 years
The PSQI is a validated instrument measuring habitual sleep patterns (bedtime, sleep latency, wake-up time, and sleep duration), specific sleep disturbances, use of sleep medication, and daytime dysfunction. Responses are summed to produce a global PSQI score ranging from 0 to 21, with higher scores indicating poorer overall sleep quality. Repeated assessment enables the investigation of changes in sleep quality over time.
Changes in body composition using Body Mass Index (BMI) and waist-to-hip ratio.
时间窗: From enrollment until the end of the study at 10 years
Body composition will be assessed using self-reported anthropometric measures, including weight (kg), height (m), waist circumference (cm), and hip circumference (cm). Body Mass Index (BMI) will be calculated using self-reported weight and height and expressed as kg/m². Waist and hip circumference will be used to derive additional indicators of body fat distribution, such as the waist-to-hip ratio. Changes in body composition are monitored by annual reporting of weight, height, and waist and hip circumference.
Changes in medication adherence using the Medication Adherence Report Scale (MARS-5).
时间窗: From enrollment until the end of the study at 10 years
MARS-5 is a validated self-report instrument that measures the extent to which individuals adhere to their prescribed medication regimen. Participants respond to five items using a 5-point Likert scale ranging from 1 ("always") to 5 ("never"), and item scores are summed to produce a total adherence score, with higher scores indicating higher levels of medication adherence. Repeated measurements allows for evaluating possible changes in adherence.
Changes in health-related quality of life using the Short Form-12 Health Survey (SF-12).
时间窗: From enrollment until the end of the study at 10 years
The SF-12 is a validated instrument that measures functional health and well-being across physical and mental domains. Responses are scored and summed to generate two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores on both components indicate better health-related quality of life. Longitudinal assessment of the SF-12 enables the evaluation of changes in quality of life over time.
All-cause mortality incidence
时间窗: From enrollment until the end of the study at 10 years
Mortality incidence will be determined based on the occurrence of death during follow-up. Date and cause of death will be obtained from the participant's general practitioner and/or medical specialist.
Self-reported hospital admissions
时间窗: From enrollment until the end of the study at 10 years
Hospital admission incidence will be determined based on the number of hospital admissions reported during follow-up. Participants will be asked to report the number of hospital admissions in the past year and the reason for each admission. These data will be used to assess the occurrence and causes of hospital admissions over time.
Self-reported morbidity
时间窗: From enrollment until the end of the study at 10 years
Incident morbidity will be determined based on newly reported medical diagnoses during the follow-up period. Participants will be asked whether they have received a new medical diagnosis during the past year and, if applicable, to specify the diagnosis.
次要结局
- Anxiety(From enrollment until the end of the study at 10 years)
- Stress(From enrollment until the end of the study at 10 years)
- Depressive symptoms(From enrollment to the end of the study at 10 years)
- Fatigue(From enrollment until the end of the study at 10 years)
- Optimism and Pessimism(From enrollment until the end of the study at 10 years)
- Positive and negative affect(From enrollment until the end of the study at 10 years)
- Mental well-being(From enrollment until the end of the study at 10 years)
- Resilience(From enrollment until the end of the study at 10 years)
- Coping(From enrollment until the end of the study at 10 years)
- Personality traits(From enrolment until the end of the study at 10 years)
- Social engagement(From enrollment until the end of the study at 10 years)
- Social isolation(From enrollment until the end of the study at 10 years)
- Partner relationship quality(From enrollment until the end of the study at 10 years)
- Life Events and Long-Term Difficulties(From enrollment until the end of the study at 10 years)
- Physical Activity Barriers and Facilitators(From enrollment until the end of the study at 10 years)
- Dietary Intake Barriers and Facilitators(From enrollment until the end of the study at 10 years)
- Health-specific self-efficacy(From enrollment until the end of the study at 10 years)
- Barriers of smoking cessation(From enrollment until the end of the study at 10 years)
- Perceived need for support(From enrollment until the end of the study at 10 years)