title: A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation.
abstract: Theory-based intervention programmes to support health-related behaviour change aim to increase health impact and improve understanding of mechanisms of behaviour change. However, the science of intervention development remains at an early stage. We present a causal modelling approach to developing complex interventions for evaluation in randomized trials. In this approach a generic model links behavioural determinants, causally through behaviour, to physiological and biochemical variables, and health outcomes. It is tailored to context, target population, behaviours and health outcomes. The development of a specific causal model based on theory and evidence is illustrated by the ProActive programme, supporting increased physical activity among individuals at risk of Type 2 diabetes. The model provides a rational guide to appropriate measures, intervention points and intervention techniques, and can be tested quantitatively. Causal modelling is critically compared to other approaches to intervention development and evaluation, and research directions are indicated.
authors.affiliation: General Practice and Primary Care Research Unit, Department of Public Health and Primary Care, Institute of Public Health, University of Cambridge, Forvie Site, Robinson Way, Cambridge CB2 2SR, UK. wendy.hardeman@phpc.cam.ac.uk
authors.forename: Wendy
authors.initials: W
authors.lastname: Hardeman
authors.forename: Stephen
authors.initials: S
authors.lastname: Sutton
authors.forename: Simon
authors.initials: S
authors.lastname: Griffin
authors.forename: Marie
authors.initials: M
authors.lastname: Johnston
authors.forename: Anthony
authors.initials: A
authors.lastname: White
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Wareham
authors.forename: Ann Louise
authors.initials: AL
authors.lastname: Kinmonth
mesh_terms: D035841:Behavioral Research; D002985:Clinical Protocols; D006801:Humans; D008960:Models, Psychological; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D006113:United Kingdom