The Devon Active Villages Evaluation (DAVE) trial: Study protocol of a stepped wedge cluster randomised trial of a community-level physical activity intervention in rural southwest England.

Background: Although physical inactivity has been linked with numerous chronic health conditions and overall mortality, the majority of English adults report doing insufficient physical activity. To increase population physical activity levels, researchers have called for more community-level interventions. To evaluate these complex public health interventions, innovative study designs are required. This study protocol describes Devon Active Villages, a community-level intervention providing physical activity opportunities to 128 rural villages in southwest England, and the methods used to evaluate its effectiveness in increasing physical activity levels. Methods/Design: A stepped wedge cluster randomised trial will be used to evaluate whether Devon Active Villages leads to increased physical activity levels in rural communities. Community engagement will help tailor activity programmes for each village; communities will then be supported for a further twelve months. The intervention will be delivered over four periods, each lasting twelve weeks. Data collection consists of a postal survey of a random sample of adults aged 18 years and over, at baseline and after each of the four intervention periods. The questionnaire includes questions on participant demographics, physical activity behaviour, local environment characteristics, awareness of local activity programmes, and psychosocial factors. Based on detecting an increase in the proportion of people who meet physical activity guidelines (from 25% to 30%), at least ten respondents are needed from each of the 128 villages at each stage (80% power at the 5% level of significance). Anticipating a 20% response rate, 6,400 questionnaires will be sent out at each stage (i.e., 50 surveys to each village). Using data from all five periods, a comparison of study outcomes between intervention and control arms will be performed, allowing for time period (as a fixed effect) and the random effect induced by correlation of outcomes (clustering) within villages. Discussion: This paper describes the use of a stepped wedge cluster randomised trial to evaluate a complex, community-level physical activity intervention in an under-studied population of adults in rural communities in southwest England. The study addresses gaps in the current literature by providing new insights into physical activity levels in this population. Trial Registration Number: Current Controlled Trials ISRCTN37321160 [ABSTRACT FROM AUTHOR]