Enhancing Lifestyle Change in Cardiac Patients Through the Do CHANGE System (“Do Cardiac Health: Advanced New Generation Ecosystem”): Randomized Controlled Trial Protocol

BACKGROUND: Promoting a healthy lifestyle (eg, physical activity, healthy diet) is crucial for the primary and secondary prevention of cardiac disease in order to decrease disease burden and mortality. OBJECTIVE: The current trial aims to evaluate the effectiveness of the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) service, which is developed to assist cardiac patients in adopting a healthy lifestyle and improving their quality of life. METHODS: Cardiac patients (ie, people who have been diagnosed with heart failure, coronary artery disease, and/or hypertension) will be recruited at three pilot sites (Badalona Serveis Assistencials, Badalona, Spain [N=75]; Buddhist Tzu Chi Dalin General Hospital, Dalin, Taiwan [N=100] and Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands [N=75]). Patients will be assisted by the Do Something Different (DSD) program to change their unhealthy habits and/or lifestyle. DSD has been developed to increase behavioral flexibility and subsequently adopt new (healthier) habits. In addition, patients’ progress will be monitored with a number of (newly developed) devices (eg, Fitbit, Beddit, COOKiT, FLUiT), which will be integrated in one application. RESULTS: The Do CHANGE trial will provide us with new insights regarding the effectiveness of the proposed intervention in different cultural settings. In addition, it will give insight into what works for whom and why. CONCLUSIONS: The Do CHANGE service integrates new technologies into a behavior change intervention in order to change the unhealthy lifestyles of cardiac patients. The program is expected to facilitate long-term, sustainable behavioral change. TRIAL REGISTRATION: Clinicaltrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305 (Archived by WebCite at http://www.webcitation.org/6wfWHvuyU).