The community-based prevention of diabetes (ComPoD) study: a randomised, waiting list controlled trial of a voluntary sector-led diabetes prevention programme.

OBJECTIVE: This two-site randomised trial compared the effectiveness of a voluntary sector-led, community-based diabetes prevention programme to a waiting-list control group at 6 months, and included an observational follow-up of the intervention arm to 12 months. METHODS: Adults aged 18-75 years at increased risk of developing type 2 diabetes due to elevated blood glucose and being overweight were recruited from primary care practices at two UK sites, with data collected in participants' homes or community venues. Participants were randomised using an online central allocation service. The intervention, comprising the prototype "Living Well, Taking Control" (LWTC) programme, involved four weekly two-hour group sessions held in local community venues to promote changes in diet and physical activity, plus planned follow-up contacts at two, three, six, nine and 12 months alongside 5 hours of additional activities/classes. Waiting list controls received usual care for 6 months before accessing the programme. The primary outcome was weight loss at 6 months. Secondary outcomes included glycated haemoglobin (HbA1c), blood pressure, physical activity, diet, health status and well-being. Only researchers conducting analyses were blinded. RESULTS: The target sample of 314 participants (157 each arm) was largely representative of local populations, including 44% men, 26% from ethnic minorities and 33% living in deprived areas. Primary outcome data were available for 285 (91%) participants (141 intervention, 144 control). Between baseline and 6 months, intervention participants on average lost more weight than controls (- 1.7 kg, 95% CI - 2.59 to - 0.85). Higher attendance was associated with greater weight loss (- 3.0 kg, 95% CI - 4.5 to - 1.5). The prototype LWTC programme more than doubled the proportion of participants losing > 5% of their body weight (21% intervention vs. 8% control, OR 2.83, 95% CI 1.36 to 5.90) and improved self-reported dietary behaviour and health status. There were no impacts on HbA1c, blood pressure, physical activity and well-being at 6 months and, amongst intervention participants, few further changes from six to 12-months (e.g. average weight re-gain 0.36 kg, 95% CI - 0.20 to 0.91). There were no serious adverse events but four exercise-related injuries were reported in the intervention arm. CONCLUSIONS: This voluntary sector-led diabetes prevention programme reached a broad spectrum of the population and had modest effects on weight-related outcomes, but limited impacts on other diabetes risk factors. TRIAL REGISTRATION: Trial registration number: ISRCTN70221670, 5 September 2014 Funder (National Institute for Health Research School for Public Health Research) project reference number: SPHR-EXE-PES-COM.

Attitudes and approaches to patient and public involvement across Europe: A systematic review.

The Innovative Medicines Initiative (IMI) is making great strides in promoting patient and public involvement (PPI) in health research across Europe, supporting patient organisations to be involved in the projects that it funds. Despite this, the literature around PPI in health services and research originating from European countries appears less than from the United Kingdom (UK), where PPI is well established. Therefore, we conducted a systematic review to explore the attitudes and approaches to PPI across Europe. Eight scientific databases were systematically searched and data extracted. Data quality was assessed using a checklist based on the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) (Staniszewska et al., Research, Involvement and Engagement, 3, 13, 2017) and the critical appraisal guidelines developed by Wright et al. (Health Expectations, 13, 359, 2010). We included all studies reporting PPI activity in both public and private health services and research institutions in the World Health Organization European region, excluding the UK, published in the English language from 1996 to 2018. Forty studies in total were included in the analysis. The studies imply a growing interest and support for the idea of PPI in health services and, to a lesser extent, in health research. There seems to be a convergence of conceptualisations of PPI across Europe, with internationally significant areas of innovative work taking place in countries such as the Netherlands and the Scandinavian countries. However, the implementation of PPI is highly uneven, and PPI is not yet firmly embedded or adequately formalised in European healthcare systems and research, possibly due to a lack of infrastructure, guidance and support. In order to try to get a better understanding of what is happening on the ground, we are carrying out a survey with potential follow-up interviews as the next part of this research project. This work is currently on hold due to the COVID-19 pandemic.