[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658156":3},{"organization":4,"outcomesModule":7,"designInfo":110,"detailedDescription":114,"studyPopulation":115,"armGroups":116,"interventions":111,"overallOfficials":111,"centralContacts":120,"locations":111,"responsibleParty":126,"collaborators":111,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":111,"enrollmentInfo":138,"targetDuration":141,"studyType":142,"phases":111,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":157,"whyStopped":111,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":111},{"fullName":5,"class":6},"Tilburg University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":103},[9,13,16,20,23,26,29,32,35,38,41],{"measure":10,"description":11,"timeFrame":12},"Changes in physical activity levels using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH).","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.","From enrollment to the end of the study at 10 years",{"measure":14,"description":15,"timeFrame":12},"Changes in dietary intake using a self-composed questionnaire based on the Dutch Healthy Diet Index (DHDI).","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.",{"measure":17,"description":18,"timeFrame":19},"Changes in alcohol consumption using a self-composed questionnaire.","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.","From enrollment until the end of the study at 10 years",{"measure":21,"description":22,"timeFrame":19},"Changes in smoking habits using self-composed items combined with the Fagerström Test for Nicotine Dependence (FTND).","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.",{"measure":24,"description":25,"timeFrame":19},"Changes in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) score.","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.",{"measure":27,"description":28,"timeFrame":19},"Changes in body composition using Body Mass Index (BMI) and waist-to-hip ratio.","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\u002Fm². 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.",{"measure":30,"description":31,"timeFrame":19},"Changes in medication adherence using the Medication Adherence Report Scale (MARS-5).","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.",{"measure":33,"description":34,"timeFrame":19},"Changes in health-related quality of life using the Short Form-12 Health Survey (SF-12).","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.",{"measure":36,"description":37,"timeFrame":19},"All-cause mortality incidence","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\u002For medical specialist.",{"measure":39,"description":40,"timeFrame":19},"Self-reported hospital admissions","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.",{"measure":42,"description":43,"timeFrame":19},"Self-reported morbidity","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.",[45,48,51,54,57,60,63,66,69,72,76,79,82,85,88,91,94,97,100],{"measure":46,"description":47,"timeFrame":19},"Anxiety","Anxiety symptoms are measured using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.",{"measure":49,"description":50,"timeFrame":19},"Stress","Stress is measured using the 10-item Perceived Stress Scale (PSS-10). Item scores are summed to generate a total score ranging from 0 to 40, with higher scores indicating greater perceived stress.",{"measure":52,"description":53,"timeFrame":12},"Depressive symptoms","Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.",{"measure":55,"description":56,"timeFrame":19},"Fatigue","Fatigue is assessed using the Multidimensional Fatigue Inventory (MFI-20). The instrument comprises five dimensions: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Subscale scores range from 4 to 20, with higher scores indicating greater fatigue.",{"measure":58,"description":59,"timeFrame":19},"Optimism and Pessimism","Optimism and pessimism are assessed using the 10-item Life Orientation Test-Revised (LOT-R). Higher scores indicate greater optimism and higher pessimism.",{"measure":61,"description":62,"timeFrame":19},"Positive and negative affect","Positive and negative affect are assessed using the Global Mood Scale (GMS). The instrument generates positive affect and negative affect scores, with higher scores indicating greater levels of the respective construct.",{"measure":64,"description":65,"timeFrame":19},"Mental well-being","Mental well-being is assessed using the WHO-5 Well-Being Index. Total scores range from 0 to 100 after standard transformation, with higher scores indicating better mental well-being.",{"measure":67,"description":68,"timeFrame":19},"Resilience","Resilience is assessed using the Brief Resilience Scale (BRS). Mean scores range from 1 to 5, with higher scores indicating greater resilience.",{"measure":70,"description":71,"timeFrame":19},"Coping","Coping strategies are assessed using the Short Cognitive Emotion Regulation Questionnaire (CERQ-short). This validated questionnaire yields scores for multiple coping strategies, with higher scores indicating greater use of the respective strategy.",{"measure":73,"description":74,"timeFrame":75},"Personality traits","Personality traits are assessed using the Big Five Inventory-2 Extra-Short Form (BFI-2-XS). The instrument provides scores for Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Open-Mindedness, with higher scores indicating greater levels of the respective personality trait.","From enrolment until the end of the study at 10 years",{"measure":77,"description":78,"timeFrame":19},"Social engagement","Social engagement is assessed using the Inventory of Social Engagement. Higher scores indicate greater social participation and engagement.",{"measure":80,"description":81,"timeFrame":19},"Social isolation","Social isolation and loneliness are assessed using the Revised UCLA Loneliness Scale. Higher scores indicate greater perceived loneliness and social isolation.",{"measure":83,"description":84,"timeFrame":19},"Partner relationship quality","The quality of the relationship with the partner is assessed using the Relationship Quality Index. Higher scores indicate better perceived quality.",{"measure":86,"description":87,"timeFrame":19},"Life Events and Long-Term Difficulties","Exposure to stressful life events and persistent difficulties is assessed using the List of Threatening Experiences and the Long-Term Difficulties Inventory. Higher scores indicate greater exposure to adverse life events and ongoing difficulties.",{"measure":89,"description":90,"timeFrame":19},"Physical Activity Barriers and Facilitators","Perceived barriers and facilitators for physical activity are assessed using self-composed questionnaires.",{"measure":92,"description":93,"timeFrame":19},"Dietary Intake Barriers and Facilitators","Perceived barriers and facilitators for healthy dietary intake are assessed using self-composed questionnaires.",{"measure":95,"description":96,"timeFrame":19},"Health-specific self-efficacy","Self-efficacy related to physical activity and healthy nutrition is assessed using health-specific self-efficacy scales. Higher scores indicate greater confidence in the ability to perform and maintain the respective health behaviour.",{"measure":98,"description":99,"timeFrame":19},"Barriers of smoking cessation","Barriers to smoking cessation are assessed using the Challenges to Stopping Smoking Scale. Higher scores indicate greater perceived challenges to quitting smoking.",{"measure":101,"description":102,"timeFrame":19},"Perceived need for support","Perceived need for support in achieving and maintaining lifestyle changes is assessed using self-composed questionnaires.",[104,107],{"measure":105,"description":106,"timeFrame":19},"Health literacy","Health literacy is measured using the validated 12-item Health Literacy Survey 2019 (HLS19-Q12). Higher total scores indicate better health literacy.",{"measure":108,"description":109,"timeFrame":19},"Socioeconomic position (SEP)","Socioeconomic position is assessed using educational level, household income, and employment status\u002Foccupation. Educational level is measured at baseline, whereas household income and employment status\u002Foccupation are assessed longitudinally. Together, these indicators are used to evaluate SEP, enabling assessment of changes in socioeconomic position over time.",{"allocation":111,"interventionModel":111,"interventionModelDescription":111,"primaryPurpose":111,"observationalModel":112,"timePerspective":113,"maskingInfo":111},null,"COHORT","PROSPECTIVE","Background and Rationale:\n\nMultimorbidity, 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.\n\nAims and Objectives:\n\nAim 1: To longitudinally identify lifestyle behaviours and their determinants in individuals with multimorbidity.\n\n* 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.\n* Objective 1b. To identify determinants of lifestyle behaviours in individuals with multimorbidity and monitor changes over time.\n* Objective 1c. To link different lifestyle trajectories to future morbidity and mortality risk.\n\nAim 2: To investigate the impact of multimorbidity on health outcomes and to identify the determinants associated with these outcomes.\n\n* Objective 2a. To assess quality of life, morbidity, and mortality risk among individuals with different combinations of multimorbidity.\n* Objective 2b. To identify the clinical, sociodemographic, medical, social, and psychological determinants associated with morbidity and mortality incidence in individuals with different combinations of multimorbidity.\n\nStudy Population:\n\nEligible participants are adults aged 18 years and older with multimorbidity, defined as the presence of at least two lifestyle-related chronic diseases. To capture the full spectrum of disease burden, disease progression, and risk of recurrence, individuals with either a current or previous diagnosis of an eligible condition will be considered for inclusion. The LifeMeds cohort focuses on chronic diseases with a strong association with lifestyle-related risk factors, including type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), chronic respiratory disease (CRD), and cancer. All cases of T2DM will be eligible for inclusion, whereas for the remaining disease groups the study will focus on the most prevalent lifestyle-related subtypes. Eligible cancer diagnoses comprise breast, colorectal, prostate, and lung\u002Fbronchus cancer. Eligible cardiovascular diseases comprise coronary artery disease, heart failure, peripheral artery disease, and hypertension, while eligible chronic respiratory diseases comprise chronic obstructive pulmonary disease (COPD) and asthma.\n\nStudy Design and Recruitment:\n\nThe LifeMeds cohort is a prospective longitudinal observational study with a planned follow-up period of 10 years. Participants will be recruited through participating hospitals and community-based recruitment strategies. In participating hospitals, eligible individuals may be informed about the study by their treating healthcare professional during routine care encounters. In addition, participants may self-register through online advertisements distributed via patient organizations and social media platforms, or through flyers distributed in community settings such as supermarkets, community centres, and pharmacies.\n\nIndividuals who meet the eligibility criteria and provide informed consent will be enrolled in the cohort. Participants will complete a baseline questionnaire followed by annual follow-up questionnaires throughout the 10-year study period.","The study population will consist of adults who have been diagnosed with at least two of the following chronic diseases: type 2 diabetes mellitus, cardiovascular disease, chronic respiratory disease and\u002For cancer. To ensure sufficient homogeneity for analysing combinations of multimorbidity while still capturing clinically relevant variation, the study focuses on the most common subtypes of these conditions with aetiologies strongly linked to lifestyle. For cancer, this includes breast , colorectal, prostate and lung cancer. For cardiovascular disease subtypes include coronary artery disease, heart failure, peripheral artery disease and hypertension. Chronic respiratory disease subtypes include chronic obstructive pulmonary disease and asthma. Finally, all clinically confirmed cases of type 2 diabetes mellitus are eligible. Individuals with a history of any of these conditions are eligible, allowing the cohort to capture the full spectrum of disease progression, remission and relapse.",[117],{"label":118,"type":111,"description":119,"interventionNames":111},"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\u002For cancer.",[121],{"name":122,"role":123,"phone":124,"phoneExt":111,"email":125},"Mirela Habibović, PhD","CONTACT","31134664020","M.Habibovic@tilburguniversity.edu",{"type":127,"investigatorFullName":111,"investigatorTitle":111,"investigatorAffiliation":111,"oldNameTitle":111,"oldOrganization":111},"SPONSOR","100658156","the-lifemeds-cohort-100658156",false,"NCT07846800","The LifeMeds Cohort","The LifeMeds Cohort: Joining Forces to Assess (Determinants of) Lifestyle Behavior, Morbidity and Mortality Among Multimorbid Individuals","LifeMeds","Inclusion Criteria:\n\n* Diagnosed with two or more of the following diseases: type 2 diabetes, cancer, cardiovascular disease and\u002For chronic respiratory diseases.\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)","ALL","18 Years",{"count":139,"type":140},2000,"ESTIMATED","10 Years","OBSERVATIONAL","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\u002For cancer. The main questions it aims to answer are:\n\n* 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?\n* How are lifestyle trajectories associated with morbidity, mortality, health-related quality of life, and other major health outcomes over time?\n\nParticipants will complete one annual questionnaire during a follow-up period of ten years.",[145,146,147,148,149],"Multimorbidity","Cancer","Cardio Vascular Disease","Chronic Respiratory Conditions","Type 2 Diabetes",[145,151,152,153,154,155,156],"Lifestyle Behavior","Determinants","Health Outcomes","Mortality","Quality of Life","Longitudinal cohort","NOT_YET_RECRUITING","2026-09-22",{"date":160,"type":161},"2026-09-29","ACTUAL",{"date":163,"type":140},"2026-12",{"date":165,"type":140},"2036-12",{"name":5,"class":6}]