An observational study in Multimorbidity, Cancer and Cardio Vascular Disease, sponsored by Tilburg University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Tilburg University · 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/or cancer. The main questions it aims to answer are:
Participants will complete one annual questionnaire during a follow-up period of ten years.
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.
Aim 2: To investigate the impact of multimorbidity on health outcomes and to identify the determinants associated with these outcomes.
Study Population:
Eligible 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/bronchus 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.
Study Design and Recruitment:
The 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.
Individuals 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/or 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.
Exclusion Criteria:
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.
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.
Time frame: From enrollment to the end of the study at 10 years
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.
Time frame: From enrollment to the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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/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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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/or medical specialist.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment to the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
Resilience
Resilience is assessed using the Brief Resilience Scale (BRS). Mean scores range from 1 to 5, with higher scores indicating greater resilience.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrolment until the end of the study at 10 years
Social engagement
Social engagement is assessed using the Inventory of Social Engagement. Higher scores indicate greater social participation and engagement.
Time frame: From enrollment until the end of the study at 10 years
Social isolation
Social isolation and loneliness are assessed using the Revised UCLA Loneliness Scale. Higher scores indicate greater perceived loneliness and social isolation.
Time frame: From enrollment until the end of the study at 10 years
Partner relationship quality
The quality of the relationship with the partner is assessed using the Relationship Quality Index. Higher scores indicate better perceived quality.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
Physical Activity Barriers and Facilitators
Perceived barriers and facilitators for physical activity are assessed using self-composed questionnaires.
Time frame: From enrollment until the end of the study at 10 years
Dietary Intake Barriers and Facilitators
Perceived barriers and facilitators for healthy dietary intake are assessed using self-composed questionnaires.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
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.
Time frame: From enrollment until the end of the study at 10 years
Perceived need for support
Perceived need for support in achieving and maintaining lifestyle changes is assessed using self-composed questionnaires.
Time frame: From enrollment until the end of the study at 10 years
Health literacy
Health literacy is measured using the validated 12-item Health Literacy Survey 2019 (HLS19-Q12). Higher total scores indicate better health literacy.
Time frame: From enrollment until the end of the study at 10 years
Socioeconomic position (SEP)
Socioeconomic position is assessed using educational level, household income, and employment status/occupation. Educational level is measured at baseline, whereas household income and employment status/occupation are assessed longitudinally. Together, these indicators are used to evaluate SEP, enabling assessment of changes in socioeconomic position over time.
Time frame: From enrollment until the end of the study at 10 years
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Tilburg University