Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With Elevated LDL-cholesterol to Reduce Cardiovascular Risk: Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating a digital health application called lipodia to see if it can help adults with high cholesterol lower their LDL cholesterol and improve other health aspects compared to regular treatment alone. The study focuses on people diagnosed with hypercholesterolemia who have LDL cholesterol levels above recommended targets for reducing cardiovascular risk. The trial aims to assess both cholesterol changes and patient confidence in managing their health. Participants are divided into two groups: one using lipodia alongside their usual treatment and a control group continuing only with their usual care. Lipodia is an interactive digital program based on health behavior change and cognitive behavioral therapy, covering topics like diet, physical activity, stress, mood, sleep, weight management, and quitting smoking or drinking. The program includes dialogues, audio, text messages, worksheets, and regular questionnaires and remains accessible for one year. During the six-month study, participants complete online questionnaires and visit a certified lab at the start, three months, and six months for blood tests measuring cholesterol and other blood fats. Researchers will track changes in LDL cholesterol primarily and also assess patient activation, quality of life, BMI, and other cholesterol measures. Both groups maintain their usual treatments, and the study includes safety and health monitoring throughout the period.

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels