The LifeMeds Cohort

NCT07846800 | Not Yet Recruiting

• 1 other identifier: NL88127.028.24
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multimorbidity; Cancer; Cardio Vascular Disease; Chronic Respiratory Conditions; Type 2 Diabetes

Keywords

Multimorbidity; Lifestyle Behavior; Determinants; Health Outcomes; Mortality; Quality of Life; Longitudinal cohort

Outcome Measures

Primary Outcomes (11)

• 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

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  From enrollment until the end of the study at 10 years

Secondary Outcomes (19)

• 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

Other Outcomes (2)

• Health literacy

  From enrollment until the end of the study at 10 years

• Socioeconomic position (SEP)

  From enrollment until the end of the study at 10 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with significant cognitive impairment (e.g. major neurocognitive disorder)

Sponsors & Collaborators

• Tilburg University: lead

MeSH Terms

Conditions

Neoplasms; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mirela Habibović, PhD

CONTACT

31134664020; M.Habibovic@tilburguniversity.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 29, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: September 29, 2026

Record last verified: 2026-09