The LifeMeds Cohort
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTilburg University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 1 trial groupGroup A: Multimorbid individuals
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 years4
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsOther outcomes
1
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 years2
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 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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