Available data:Attached files include the research protocol and codebook with an overview of research methods and available data of the OPTICARE XL RCT. Furthermore, the document "terms of use" gives instructions on how and under which circumstances data can be requested.Permission for reuse of data:Data can only be shared of patients that gave specific permission for reuse of data by third parties (this was an item on the signed informed consent form). A total of 191 out of 201 participating patients (95%) gave this permission.Summary of OPTICARE XL study:Rationale: Obese cardiac patients currently participate in usual cardiac rehabilitation (CR) programs. However, effects achieved are substantially smaller than in non-obese patients, and non-lasting. We hypothesize that a novel tailor-made program (OPTICARE-XL) will lead to behavioral change towards a healthier lifestyle, resulting in improved health and quality of life in a cost-effective way.Objective: Aim is to determine (cost-) effectiveness of a novel CR program specific for obese cardiac patients, OPTICARE-XL, in comparison with usual CR.Study design: Multicenter randomized controlled trialStudy population: 201 obese patients (BMI>30) with coronary artery disease (CAD) or atrium fibrillation (AF) (>18 years) who fulfill the guidelines for participation in CR, after screening for psychopathology.Intervention: Patients are randomized to:OPTICARE XL (n=102): A one-year tailor-made behavioral group intervention including after-care, specific for obese patients, with strong focus on self-management. Upon usual education sessions and facultative modules (stress management/smoking cessation), OPTICARE-XL includes peer group modules on healthy weight and active lifestyle management, and tailored fitness training (aerobic and muscle strength training).OrUSUAL CARE (n=99): Usual 3-month CR group program without after-care in which both obese and non-obese patients participate. Usual CR combines aerobic fitness training with education sessions and facultative modules (stress management/smoking cessation).

Date Submitted: 2021-03-25