ProActive is a four-year study with a complex randomised trial design [30 (link)], with central randomisation of willing participants to intervention programmes or comparison. The trial is managed from the Institute of Public Health, University of Cambridge, following MRC guidelines. Ethical approval has been obtained from the Eastern MREC, and West Suffolk, Cambridge, Huntingdon and West Essex LRECs.
The study design and patient flows (achieved at recruitment closure, October 2003, and projected to end of study) are shown in Figure 1. The focus of measurement is the adult offspring of a Type 2 diabetic parent, but the focus of the intervention programme is this individual within a family context. Participants were recruited via parents with diabetes on primary care registers (20 practices), or directly through records of their family history of diabetes (seven of the 20 practices). Sedentary individuals and their families were randomised to facilitation, either 'face-to-face' or 'distance', or to a comparison arm offering a leaflet providing brief advice on the benefits of activity. Psychological, physiological, anthropometric and biochemical data were collected at baseline and one year after randomisation, with psychological data also collected at six months after randomisation.
The study is explanatory in design, and the quality-assured intervention programmes are delivered by carefully trained and supervised family health facilitators with experience of working in primary care or the community, and backgrounds in health promotion, dietetics and nursing.
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