The first objective of this study is to compare cardiometabolic and mental health across the four interregion Meuse-rhine (IMR). The second objective is to compare six key lifestyle pillars, as defined by the American College of Lifestyle Medicine: physical activity, diet, stress management, sleep quality, social connection, and substance use. Physical activity will be objectively and continuously monitored using a wearable device, while the other five lifestyle factors will be assessed through validated questionnaires at pre- and postintervention. Finally, we will evaluate the effects of a physical activity intervention on cardiometabolic health, mental health, and the six lifestyle pillars. By addressing these objectives, this study aims to generate valuable insights to inform policymakers and support region-specific interventions for improving health and lifestyle across the IMR.
This multicentric interventional study will be conducted at four sites: Hasselt University, Liège University, Maastricht University, and Aachen University. The study includes a pre- and post-intervention visit, with a three-month intervention period followed by a three-month follow-up. Participants will be recruited via a subscription link, where they will provide demographic information after giving informed consent. Based on the inclusion criteria, 1000 participants will be included in total (250 participants per site). Ethical approval documents for the two sites in Belgium will be submitted simultaneously. Documents for Maastricht University and Aachen University will be submitted afterward, and the ethical approvals will be sent to the Belgian ethical committees.
A quota for educational level will be implemented, limiting highly educated participants to a maximum of 25% per region to reflect the educational distribution of the IMR population. This ensures a more representative sample, as highly educated individuals are often overrepresented in research.
To minimise seasonal effects on physical activity, participant inclusion will be divided into four groups and spread throughout the year. At each site, approximately 65 participants will start in September 2025, another group in December '25/January '26, a third group in March/April '26, and a final group in June/July '26.
Participants will be recruited through online and paper advertisements, including a subscription link to the screening questionnaire. Selected participants will receive detailed study information via phone or email, based on their indicated preference. Data from unselected participants will be deleted after recruitment is completed. Those who agree to participate will be invited for a first study visit, where they will provide written informed consent. Selected participants may withdraw at any time for any reason. In such cases, previously collected research data will be retained, but contact details will be deleted, and their name will be removed from the subject identification list.
During the first study visit, all study procedures and outcome measures will be explained, and participants will provide written informed consent. Next, they will complete questionnaires on their sociodemographic factors, mental health and lifestyle factors using an iPad or computer. These questionnaires will be accessed via a secured link sent by the EDC Castor system to a fictitious email address created in advance for each participant. A member of the research team will prepare the questionnaires for each participant and verify their correct submission afterward. Following this, blood pressure and anthropometric measurements will be taken, and a venous blood sample will be drawn by a certified nurse or doctor. Participants will then receive their wearable along with assistance for installation and connection to their smartphone. Additionally, a subsample of participants (n = 75 per site) will be asked to install M-Path on their smartphone for ecological momentary assessment of mental health. Technical support will be provided as needed.
The same measurements will be repeated during the post-intervention study visit. For sociodemographic factors, participants will be asked if any changes have occurred and, if so, to specify them. In addition, participants will have to answer four questions on intervention adherence and possible barriers they experienced. Statistical analysis will be performed using IBM SPSS Statistics (version 28.0.1.1, IBM Corp., Armonk, NY, USA).
Aged between 40 and 65 years
Resident of Belgian Limburg, Liège, Netherlands Limburg or Aachen, with the intention to remain there for at least one year
Able to wear a wrist-worn wearable for at least 10 hours per day during waking hours
Own a smartphone and have a valid email address
None
Single group
Smartwatches with progressive step targets
DeviceParticipants will receive a wearable to track their physical activity levels. Step goals will be provided before the intervention begins and again in weeks 4, 7, and 10 via email. These personalised goals will be based on each participant's actual step count from the previous week. The initial goal will encourage participants to increase their baseline step count by 500 steps per day. If they meet this target, their next goal (week 4) will be to increase by 1,000 steps per day from baseline. If they do not meet the first goal, they will again be encouraged to increase by 500 steps per day. Participants who significantly exceed their goal (\>500 steps/day above their goal) will be encouraged to maintain their activity level, with reassessment at each goal-setting point. Participants who meet all targets will achieve a total increase of 2,000 steps per day at twelve weeks of follow-up. In addition, educational videos will be made available via a YouTube channel to enhance participation.
10-year risk of cardiovascular disease
A venous blood sample will be collected in two tubes: one 9ml lithium-heparin (Li-hep) tube and 6ml ethylenediaminetetraacetic acid (EDTA) tube. These samples will be used to assess the following parameters: Cholesterol; Inflammation; Kidney function ; Glucose metabolism. Systolic and diastolic blood pressure as well as resting heart rate will be measured four times and documented as the mean value of the final 3 measurements. Mean arterial pressure (MAP) is calculated as MAP = systolic BP + (2 x diastolic BP) / 3. The 10-year risk of cardiovascular disease (CVD), including non-fatal stroke, non-fatal myocardial infarction, or death due to CVD, will be calculated using different risk models based on participants' health status such as the SCORE 2 and SMART2 model.All risk calculations incorporate the blood lipid profile, systolic blood pressure, sex, age, and smoking behaviour, kidney function, diabetes status, body mass index, medication use, and duration of previous CVD.
Body mass index
To measure anthropometrics and body fat distribution, participants will be in light clothing. Body height will be measured to the nearest 0.1 cm using a wall-mounted Harpenden stadiometer. Body weight will be measured to the nearest 0.1 kg using a digital, calibrated weighing scale. Body mass index (BMI) will be calculated as weight (kg) divided by height squared (m²).
Body fat distribution
Waist and hip circumferences will be measured to the nearest 0.1 cm using a flexible metric measuring tape. Waist circumference will be taken at the midpoint between the lower rib margin and the top of the iliac crest. Hip circumference will be measured at the widest part of the hips at the level of the greater trochanter. The waist-to-hip ratio will be calculated by dividing waist circumference (cm) by hip circumference (cm).
Hospital Anxiety and Depression Scale
To assess mental health, participants will complete the Hospital Anxiety and Depression Scale (HADS), a widely used tool designed to measure symptoms of anxiety and depression\[17\]. The questionnaire consists of 14 items, with 7 items assessing anxiety (HADS-A) and 7 items assessing depression (HADS-D).
Sociodemograpgics variables
All personal informations relative to the participants such as: age, gender, education level, etc.
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University of Liege
Lead sponsor
Maastricht University
Collaborator
RWTH Aachen University
Collaborator
Hasselt University
Collaborator
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