title: Randomized study designs for lifestyle interventions: a tutorial.
abstract: Unhealthy lifestyle behaviours are considered modifiable risk factors for many diseases. Lifestyle interventions that target these behaviours need rigorous evaluation to assess their effectiveness. The randomized controlled trial is the study design of choice when it comes to the evaluation of interventions. However, lifestyle interventions are often complex and subject to several important issues, such as patient preference and non-adherence, that may threaten the internal and external validity of studies. There is a strong demand for high-quality randomized controlled trials of interventions that promote healthy lifestyle behaviours. With this tutorial we aim to provide guidance in the choice of an optimal randomized controlled trial design in future trials of lifestyle interventions.
authors.affiliation: Department of Epidemiology, Department of Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: John O
authors.initials: JO
authors.lastname: Younge
authors.affiliation: Department of Epidemiology.
authors.forename: Tessa A
authors.initials: TA
authors.lastname: Kouwenhoven-Pasmooij
authors.affiliation: Department of Epidemiology, Monash University, Department of Epidemiology and Preventive Medicine, Melbourne, VIC, Australia.
authors.forename: Rosanne
authors.initials: R
authors.lastname: Freak-Poli
authors.affiliation: Department of Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands.
authors.forename: Jolien W
authors.initials: JW
authors.lastname: Roos-Hesselink
authors.affiliation: Department of Epidemiology, Department of Radiology, Erasmus Medical Centre, Rotterdam, The Netherlands and Harvard T.H. Chan School of Public Health, Centre for Health Decision Sciences, Boston, MA, USA m.hunink@erasmusmc.nl.
authors.forename: Mg Myriam
authors.initials: MM
authors.lastname: Hunink
mesh_terms: D000428:Alcohol Drinking; D019317:Evidence-Based Medicine; D015444:Exercise; D005247:Feeding Behavior; D006801:Humans; D008019:Life Style; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D040242:Risk Reduction Behavior; D016540:Smoking Cessation
keywords: Lifestyle intervention; randomized controlled trial; study design; tutorial