A community based primary prevention programme for type 2 diabetes integrating identification and lifestyle intervention for prevention: the Let's Prevent Diabetes cluster randomised controlled trial☆
Introduction
Type 2 diabetes mellitus (T2DM) is associated with reduced quality of life and serious complications. The life expectancy of individuals with T2DM may be shortened by as much as 10 years, with most dying of cardiovascular diseases (CVD) (Roper et al., 2001). The management of T2DM consumes around 10% of health care expenditure (Hex et al., 2012). Consequently, the prevention of T2DM is a priority and has been highlighted by the NHS, UK, as one of four priority areas (NHS, 2014).
Pre-diabetes (PDM) is a high-risk state where glucose levels are elevated but do not reach the threshold for diagnosis of T2DM. Trials have unequivocally demonstrated that lifestyle interventions, which promote moderate to vigorous-intensity physical activity, a healthy diet and weight regulation, reduce the risk of progressing to T2DM by 30%–60% in those with PDM (Gillies et al., 2007). For example, the Finnish Diabetes Prevention Study (DPS) found that the risk of T2DM was reduced by 58% in those referred to an intensive lifestyle intervention compared to usual care over a three-year period (Tuomilehto et al., 2001). Consistent findings have been reported from the USA Diabetes Prevention Program (DPP) (Knowler et al., 2002).
Despite the strong evidence for lifestyle interventions in the prevention of T2DM, there has been a translational gap between trial evidence and implementation into routine care. This is predominantly due to the resource-intensive nature of lifestyle interventions tested. For example, in the first year of the DPP programme, participants received 16 1 h one-to-one counselling sessions followed by an average of eight additional contacts and two telephone consultations. The participants were also offered supervised exercise classes (Knowler et al., 2002). This intensity of care is incompatible with routine care pathways. Therefore, the emphasis needs to be shifted to examining the effectiveness of approaches designed for implementation within routine primary care. As healthcare services have differences in funding, organisation and infrastructure, programmes cannot be assumed to be generalisable across contexts. To date there has been a dearth of evidence concerning T2DM prevention in the UK, with small-scale projects showing mixed results (Yates et al., 2009, Dyson et al., 1997, Oldroyd et al., 2006, Bhopal et al., 2014).
This study assesses whether the Let's Prevent T2DM programme is effective at preventing progression to T2DM in people with PDM identified through a systematic screening pathway within primary care. Let's Prevent is a pragmatic, relatively low resource, group-based structured-education programme targeting lifestyle behaviour change specifically designed for implementation within a community setting.
Section snippets
Methods
The study had two phases. The first was a screening phase which identified people at risk of PDM/T2DM through the use of a screening tool that had been developed and validated for use within primary care (Gray et al., 2012a, Gray et al., 2012b). In the second phase, the participants who had been screened and found to have PDM progressed to the cluster RCT. The cluster RCT design has been described in detail elsewhere (Gray et al., 2012c). The trial randomised practices to avoid the risk of
Results
Overall, 43 practices were included; ranging in size from 1650 to 24,000. The median number of participants with PDM recruited per practice was 23 in the standard-care arm and 17 in the intervention arm; the number recruited per practice ranged from 2 to 49. In total 880 participants were recruited (433 standard care, 447 intervention, Fig. 1). At 36 months 76% of the intervention group attended compared to 79% in the standard-care arm (p = 0.43). Compared to those who attended at 36 months,
Discussion
To our knowledge, this is the first study investigating the effectiveness of a T2DM prevention programme within primary care in the UK. We have shown that a pragmatic, low-resource, three-year T2DM prevention programme, based on a 6 h , group-based, structured-education session followed by two annual group-based sessions and nine telephone contacts, can lead to improvements in markers of metabolic health, psychosocial well-being, and health behaviour. The primary outcome of the study was
Conclusion
We have shown that a relatively low-resource, pragmatic T2DM prevention programme can lead to modest improvements to biomedical, lifestyle and psychosocial outcomes without significantly reducing the risk of T2DM. The findings have important implications for future research and primary care.
Funding and ethics
This research was funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0606-1272). This report/article presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0606-1272). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Ethical approval
Contributor statements
MJD is the principal investigator for the Let's Prevent programme grant, initiated the project, commented on the drafts of the paper and approved the final version. MJD is the guarantor for the paper and affirms that the manuscript is an honest, accurate, and transparent account of the study being reported, that no important aspects of the study have been omitted, and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. LJG wrote the statistical
Conflicts of interests
Laura J Gray, Jacqui Troughton, Alastair Gray, Jaakko Tuomilehto and Azhar Farooqi declare no support from any organisation for the submitted work, no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years, and no other relationships or activities that could appear to have influenced the submitted work. Melanie J Davies, Kamlesh Khunti and Thomas Yates declare no support from any organisation for the submitted work and no
Transparency document
Acknowledgments
The project was supported by the University of Leicester Clinical Trials Unit, the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care — East Midlands (NIHR CLAHRC — EM), and the NIHR Leicester–Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, which is a partnership between University Hospitals of Leicester NHS Trust, Loughborough University and the University of Leicester.
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2022, Journal of Affective DisordersCitation Excerpt :Reasons for exclusion are detailed in Fig. 1. In sum, 53 RCTs were included for qualitative synthesis (Abraham et al., 2020; Advocat et al., 2016; Alkoudsi et al., 2020; Barlow et al., 2009; Bendtsen et al., 2020; Brennan et al., 2012; Chow et al., 2020; Dale et al., 2015; Davies et al., 2016; Deitz et al., 2014; Devi et al., 2014; Dodd et al., 2016; Forsyth et al., 2015; Furuya et al., 2015; Giallo et al., 2014; Goodman et al., 2008; Heutink et al., 2012; Hilmarsdóttir et al., 2021; Hughes et al., 2020; Hwang and Jo, 2019; Ihle-Hansen et al., 2014; Imayama et al., 2011; Ip et al., 2021; Islam et al., 2013; Jonsdottir et al., 2015; Kim et al., 2011; Kirk et al., 2014; Kokka et al., 2019; Lambert et al., 2007; Langhorst et al., 2007; Leemrijse et al., 2016; Lou et al., 2015; Markomanolaki et al., 2019; Martín et al., 2014; Melnyk et al., 2009, 2013; Melnyk et al., 2020; Mensorio et al., 2019; Meyer et al., 2021; Mitchell et al., 2014; Morales-Fernández et al., 2021; Murawski et al., 2019; Nápoles et al., 2020; Nie et al., 2019; Przybylko et al., 2021; Sampson et al., 2019; Sheean et al., 2021; Sorensen et al., 1999; Su and Yu, 2021; Trento et al., 2020; Wong et al., 2021b; Ye et al., 2016; Yudi et al., 2021). Of these, 34 of them provided sufficient data in the published papers for quantitative synthesis.
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Trial Registration: ISRCTN80605705.