Study design
The Devon Active Villages Evaluation (DAVE) protocol is based on a stepped wedge cluster randomised controlled trial design (Figure 1). During the DAVE study, the intervention will be rolled out sequentially to 128 rural villages (clusters) over four time periods. The evaluation will consist of data collection at five fixed time points (baseline and following each of the four intervention periods). The period in which the villages first receive the intervention will be randomly assigned, stratified by the seven regions of the county of Devon (see below). The intervention will be fully implemented by the end of the trial, with all 128 villages receiving the intervention: 22 first receiving the intervention at period 2, 36 at period 3, 35 at period 4, and 35 at period 5.
Setting and participants
Devon Active Villages is a community-level intervention coordinated by Active Devon, the Devon county partnership for sport and physical activity. Active Devon received circa £950,000 funding for the Devon Active Villages intervention from Sport England (the government body for sports promotion) and Devon County Council as part of Sport England’s ‘Rural Communities’ funding scheme. The Devon Active Villages Evaluation (DAVE) research study is being conducted by the University of Exeter in close liaison with Active Devon.
Devon is characterised by ten distinct regions, of which three are urban (Exeter, Plymouth and Torbay), and seven are rural (East Devon, Mid Devon, North Devon, South Hams, Teignbridge, Torridge and West Devon). All intervention villages are located in one of the seven rural regions. The Devon Active Villages intervention will provide activities for all age groups.
In the initial planning of the intervention, Active Devon identified 155 rural villages to receive the Devon Active Villages intervention across the course of three years. Prior to the intervention, Active Devon ran a pilot intervention with 15 villages, the outcome of which was used to inform the main intervention protocol.
Recruitment and randomisation
Of the remaining 140 villages that were not part of the pilot, twelve could not be included in the evaluation due to engagement with local community members before baseline data collection had commenced. Thus, the remaining 128 villages (clusters) were recruited and randomised to first receive the intervention in one of the four periods, stratified by region. Villages with populations of 500–2000 people formed the sampling frame for the intervention. These population boundaries were set so that villages were large enough to have local facilities suitable for physical activity, but limited in the amount of activity opportunities they offered.
Data collection for the evaluation study will focus on adults aged 18 years and over. The study will use a repeated cross-sectional design, in which a random sample of people within each cluster will be surveyed at each stage. A complete list of all households in each of the 128 study villages will be obtained using the Postcode Address File (Address List Utility, Arc en Ciel, Version 3.1 PAF Quarter 1, 2011). The order in which households are approached to participate in the survey at each stage will be randomly generated. One adult per household will be randomly selected. If there are multiple eligible adults in the household, an invitation to complete the survey will be given to the adult who has most recently had a birthday.
Intervention
The primary objective of the Devon Active Villages intervention is to improve participation in physical activity by offering people of all ages increased opportunities to experience the enjoyment of sport and physical activity. The intervention will be implemented and coordinated locally by Local Delivery Partners. Local Delivery Partners include District Authority Sports Development Teams and community-based charitable organisations, some of which manage local facilities as well as maintain and develop activity opportunities in the local area. Each Local Delivery Partner will deliver the intervention in one of the seven regions. It was necessary to have different Local Delivery Partners for each area due to the large number of villages receiving the intervention in each period, and because the villages are spread across the whole county. No one Local Delivery Partner is of sufficient size to cover the whole county. Each Local Delivery Partner is given strategic support from Active Devon as well as a clear framework and timescales around the delivery of the intervention with strong focus on generating a local needs led approach to designing the activities.
Each village will receive a ‘community engagement phase’ for twelve weeks prior to the intervention (Figure 2). During this phase, Local Delivery Partners will engage with the local people, elected member structures, schools and other community groups to carry out a local needs assessment, an assessment of the activities currently on offer, and the activities’ take-up and capacity. This will often include, but not limited to, people being directly surveyed to find out what activities they would like the Devon Active Villages programme to provide.
The programme will then deliver twelve weeks of physical activity sessions, with each village receiving at least three different types of activities. These activity sessions will be subsidised using programme funds. Local Delivery Partners will coordinate delivery of the intervention by finding suitable activity venues, purchasing necessary equipment and hiring local experts to deliver the activities. Community volunteers will also be recruited to help run the activities and will be provided with mentoring support throughout the programme. Local Delivery Partners will advertise the Devon Active Villages activity sessions using local media (e.g., newspapers, posters, leaflets, village newsletters).
Each village will also be supported for twelve months following the intervention, when Local Delivery Partners will help the communities to sustain the intervention activities, by providing specialist support, regular mentoring for the volunteers and additional funding or equipment if necessary. Additionally, local people will be offered coaching qualifications to help the villages continue the activities independently.
Outcome measurement
The primary analysis will compare the proportion of adults meeting recommended guidelines for the minimum level of physical activity (i.e., 150 minutes of moderate intensity physical activity per week or 75 minutes of vigorous intensity physical activity per week) between the intervention and control modes. Secondary outcomes will be social support, physical activity intentions, awareness and use of local facilities, perceived village supportiveness of physical activity, and awareness and participation in the Devon Active Villages intervention.
Data collection
Postal questionnaires and participant information sheets will be sent out to participants at baseline (in the month prior to the first intervention period commencing) and within a week of each of the four intervention periods ending (Figure 2). The participant information sheet makes clear the voluntary nature of the study and therefore informed consent to participate in the study will be implied when participants return a completed questionnaire. If the number of completed questionnaires returned within three weeks of the initial mailing is insufficient, additional questionnaires will be sent out to new households. Participants will receive the questionnaire, a participant information sheet and a prepaid return envelope. It is possible that some individuals may receive the questionnaire on two or more occasions. In such cases, if returned, demographic variables (gender, age, height, weight) will be used to identify this wherever possible. These participants will remain in the analysis, but it will be recorded that each participant has completed the questionnaire on more than one occasion.
Measures
Demographic characteristics
The survey will include questions on gender, age, height, weight, health, occupation, car ownership, children in the household, and dog ownership, based on questions from national surveys from different populations (e.g., Burton et al., [25], Craig et al., [5]).
Physical activity
Physical activity will be measured using the short version of the International Physical Activity Questionnaire (IPAQ) [26]. The IPAQ short-form consists of questions on the number of days and time spent on physical activity at moderate and vigorous intensity, as well as time spent walking and sitting. The mean values for each activity category will be calculated and expressed as metabolic equivalent (MET) minutes per week, and combined to categorise people into ‘low’, ‘moderate’ or ‘high’ activity classifications. The self-administered short-form IPAQ has been found to have acceptable levels of validity and reliability [26].
Local area
To assess perceived characteristics of the local environment a scale will be used that was initially developed for use in another United Kingdom health study. Participants are asked to rate their agreement with 12 items on factors such as aesthetics, green space, access to amenities, traffic, safety and convenience of routes. The scale has been found to have acceptable levels of test-retest reliability [27]. Questions on perceived proximity and use of different recreational facilities are also included. These items were previously found to have acceptable test-retest reliability [28].
Physical activity campaigns/programmes
The survey will contain questions on participants’ awareness of and participation in local physical activity campaigns. The survey will also ask about awareness of Devon Active Villages, participation in programme events, and opinions on the programme.
Psychosocial correlates
Participants will be asked about their intentions to be more active in the future. The survey will also ask them to rate the importance they place on physical activity on a scale from 0 (not at all) to 10 (very), as well as their physical activity confidence and the extent to which they are trying to do more activity [29]. Finally, a series of eight questions will ask participants to rate their agreement with statements about their physical activity habits, social norms, and perceived village supportiveness of activity. These questions were initially developed for use in an Australian cohort study (n = 2,485) [25].
Sample size
To detect an increase from 25% to 30% in the percentage of people who meet guidelines for recommended physical activity levels, 10 participants need to be recruited from each of the 128 villages at each study period to achieve 80% power at the 5% significance level [30]. A recent pilot for a population study of travel behaviour in the United Kingdom achieved a response rate of 20% for a short questionnaire postal survey [31]. On this basis, 50 surveys will be sent out to each village at each stage, anticipating that we will obtain at least 10 responses per village per stage (20% response rate). This means that 6,400 surveys will be sent out at every stage with the expectation that at least 1,280 will be completed and returned. If this response rate is not achieved within three weeks of the surveys being posted, an additional five surveys will be sent out to extra households for every one survey missing (20% response rate).
Statistical analysis
For any given outcome, data collected across all five periods will be used in a single analysis comparing the intervention and control modes. Analyses will use the intention-to-treat principle, with participants analysed according to the mode their village (cluster) was in for the stage at which they provided outcome data. Random effects (“multilevel”) linear regression models estimated using maximum likelihood [32] will be fitted to compare quantitative outcomes between the intervention and control modes, specifying the village effect as random; marginal logistic regression models using Generalised Estimating Equations (GEE) with information sandwich (“robust”) estimates of standard error specifying an exchangeable correlation structure [33] will be fitted to compare binary outcomes. Both the random effects model and GEE methods allow for correlation of outcomes within the same village cluster. Under both methods, a binary predictor variable will be used to indicate intervention versus control status and period of study, gender and age will be adjusted for. All analyses will be carried out using Stata software (StataCorp. 2011. Stata Statistical Software: Release 12. College Station, TX: StataCorp LP).
Ethical consideration
The study received ethical approval from the Sport and Health Sciences Ethics Committee at the University of Exeter (February 2011).