Uitdagingen bij onderzoek naar complexe interventies

Lifestyle interventions potentially contribute to the prevention and treatment of a number of common chronic diseases, such as type 2 diabetes and obesity. Nobody questions the importance of a healthy lifestyle, but at the same time it is clear that the effectiveness of lifestyle interventions has often not been investigated in a randomized controlled study, whereas the randomized clinical trial (RCT) is the golden standard in clinical drug research. In this article we discuss the methodological (im)possibilities of using RCTs in evaluating the effects of lifestyle interventions. We also explore the value of other research methods, especially carefully designed non-randomized clinical trials. Under the right conditions, non-randomized ‘real world’ research can provide valid evidence for the effectiveness and safety of lifestyle interventions.

Conflict of interest and financial support: potential conflicts of interest have been reported for this article. ICMJE forms provided by the authors are available online along with the full text of this article.