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.
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The gestational weight gain and public health benefits of pregnancy lifestyle interventions are enhanced by the associated improvement in clinically prioritized maternal outcomes.
“The GWG and public health benefits of pregnancy lifestyle interventions are enhanced by the associated improvement in clinically prioritized maternal outcomes.13”
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- Authors
- Younge, J. O., Kouwenhoven-Pasmooij, T. A., Freak-Poli, R., Roos-Hesselink, J. W., & Hunink, M. M.
- Affiliations
- Erasmus MC (NL)
- Venue
- International Journal of Epidemiology
- Publisher
- Oxford University Press (OUP)
- Published
- 2015-09-15
- Volume
- 44
- Issue
- 6
- Pages
- 2006-2019
- ISSN
- 0300-5771 (ISSN-L)
- 1464-3685
- OpenAlex
- W2265712261
- Cited by
- 57
- References
- 68
- Citations by year
- 2026: 3 · 2025: 10 · 2024: 5 · 2023: 5 · 2022: 5 · 2021: 8 · 2020: 7 · 2019: 6 · 2018: 5 · 2017: 2 · 2015: 1
- FWCI
- 0.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Journal of Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- lifestyle intervention, randomized controlled trial design, healthy lifestyle behaviours, modifiable risk factors, patient preferences, medication adherence, internal validity, generalizability
- MeSH terms
- Alcohol Drinking, Feeding Behavior, Humans, Life Style, Research Design, Exercise, Randomized Controlled Trials as Topic, Smoking Cessation, Evidence-Based Medicine, Risk Reduction Behavior
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