R Bhopal

Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial.

BACKGROUND The susceptibility to type 2 diabetes of people of south Asian descent is established, but there is little trial-based evidence for interventions to tackle this problem. We assessed a weight control and physical activity intervention in south Asian individuals in the UK. METHODS We did this non-blinded trial in two National Health Service (NHS) regions in Scotland (UK). Between July 1, 2007, and Oct 31, 2009, we recruited men and women of Indian and Pakistani origin, aged 35 years or older, with waist circumference 90 cm or greater in men or 80 cm or greater in women, and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test. Families were randomised (using a random number generator program, with permuted blocks of random size, stratified by location [Edinburgh or Glasgow], ethnic group [Indian or Pakistani], and number of participants in the family [one vs more than one]) to intervention or control. Participants in the same family were not randomised separately. The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period. The primary outcome was weight change at 3 years. Analysis was by modified intention to treat, excluding participants who died or were lost to follow-up. We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years. This trial is registered, number ISRCTN25729565. FINDINGS Of 1319 people who were screened with an oral glucose tolerance test, 196 (15%) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial. Participants were in 156 family clusters that were randomised (78 families with 85 participants were allocated to intervention; 78 families with 86 participants were allocated to control). 167 (98%) participants in 152 families completed the trial. Mean weight loss in the intervention group was 1.13 kg (SD 4.12), compared with a mean weight gain of 0.51 kg (3.65) in the control group, an adjusted mean difference of -1.64 kg (95% CI -2.83 to -0.44). INTERPRETATION Modest, medium-term changes in weight are achievable as a component of lifestyle-change strategies, which might control or prevent adiposity-related diseases. FUNDING National Prevention Research Initiative, NHS Research and Development; NHS National Services Scotland; NHS Health Scotland.

Sitting Time and Waist Circumference Are Associated With Glycemia in U.K. South Asians Data from 1,228 adults screened for the PODOSA trial

OBJECTIVE To investigate the independent contributions of waist circumference, physical activity, and sedentary behavior on glycemia in South Asians living in Scotland. RESEARCH DESIGN AND METHODS Participants were 1,228 (523 men and 705 women) adults of Indian or Pakistani origin screened for the Prevention of Type 2 Diabetes and Obesity in South Asians (PODOSA) trial. All undertook an oral glucose tolerance test, had physical activity and sitting time assessed by International Physical Activity Questionnaire, and had waist circumference measured. RESULTS Mean ± SD age and waist circumference were 49.8 ± 10.1 years and 99.2 ± 10.2 cm, respectively. One hundred ninety-one participants had impaired fasting glycemia or impaired glucose tolerance, and 97 had possible type 2 diabetes. In multivariate regression analysis, age (0.012 mmol ⋅ L−1 ⋅ year−1 [95% CI 0.006–0.017]) and waist circumference (0.018 mmol ⋅ L−1 ⋅ cm−1 [0.012–0.024]) were significantly independently associated with fasting glucose concentration, and age (0.032 mmol ⋅ L−1 ⋅ year−1 [0.016–0.049]), waist (0.057 mmol ⋅ L−1 ⋅ cm−1 [0.040–0.074]), and sitting time (0.097 mmol ⋅ L−1 ⋅ h−1 ⋅ day−1 [0.036–0.158]) were significantly independently associated with 2-h glucose concentration. Vigorous activity time had a borderline significant association with 2-h glucose concentration (−0.819 mmol ⋅ L−1 ⋅ h−1 ⋅ day−1 [−1.672 to 0.034]) in the multivariate model. CONCLUSIONS These data highlight an important relationship between sitting time and 2-h glucose levels in U.K. South Asians, independent of physical activity and waist circumference. Although the data are cross-sectional and thus do not permit firm conclusions about causality to be drawn, the results suggest that further study investigating the effects of sitting time on glycemia and other aspects of metabolic risk in South Asian populations is warranted.

Culturally adapting the prevention of diabetes and obesity in South Asians (PODOSA) trial

Type 2 diabetes is extremely common in South Asians, e.g. in men from Pakistani and Indian populations it is about three times as likely as in the general population in England, despite similarities in body mass index. Lifestyle interventions reduce the incidence of diabetes. Trials in Europe and North America have not, however, reported on the impact on South Asian populations separately or provided the details of their cross-cultural adaptation processes. Prevention of diabetes and obesity in South Asians (PODOSA) is a randomized, controlled trial in Scotland of an adapted, lifestyle intervention aimed at reducing weight and increasing physical activity to reduce type 2 diabetes in Indians and Pakistanis. The trial was adapted from the Finnish Diabetes Prevention Study. We describe, reflect on and discuss the following key issues: The core adaptations to the trial design, particularly the delivery of the intervention in homes by dietitians rather than in clinics. The use of both a multilingual panel and professional translators to help translate and/or develop materials. The processes and challenges of phonetic translation. How intervention resources were adapted, modified, newly developed and translated into Urdu and Gurmukhi (written Punjabi). The insights gained in PODOSA (including time pressures on investigators, imperfections in the adaptation process, the power of verbal rather than written information, the utilization of English and the mother-tongue languages simultaneously by participants and the costs) might help the research community, given the challenge of health promotion in multi-ethnic, urban societies.

Design and baseline characteristics of the PODOSA (Prevention of Diabetes & Obesity in South Asians) trial: a cluster, randomised lifestyle intervention in Indian and Pakistani adults with impaired glycaemia at high risk of developing type 2 diabetes

Objectives To describe the design and baseline population characteristics of an adapted lifestyle intervention trial aimed at reducing weight and increasing physical activity in people of Indian and Pakistani origin at high risk of developing type 2 diabetes. Design Cluster, randomised controlled trial. Setting Community-based in Edinburgh and Glasgow, Scotland, UK. Participants 156 families, comprising 171 people with impaired glycaemia, and waist sizes ≥90 cm (men) and ≥80 cm (women), plus 124 family volunteers. Interventions Families were randomised into either an intensive intervention of 15 dietitian visits providing lifestyle advice, or a light (control) intervention of four visits, over a period of 3 years. Outcome measures The primary outcome is a change in mean weight between baseline and 3 years. Secondary outcomes are changes in waist, hip, body mass index, plasma blood glucose and physical activity. The cost of the intervention will be measured. Qualitative work will seek to understand factors that motivated participation and retention in the trial and families’ experience of adhering to the interventions. Results Between July 2007 and October 2009, 171 people with impaired glycaemia, along with 124 family volunteers, were randomised. In total, 95% (171/196) of eligible participants agreed to proceed to the 3-year trial. Only 13 of the 156 families contained more than one recruit with impaired glycaemia. We have recruited sufficient participants to undertake an adequately powered trial to detect a mean difference in weight of 2.5 kg between the intensive and light intervention groups at the 5% significance level. Over half the families include family volunteers. The main participants have a mean age of 52 years and 64% are women. Conclusions Prevention of Diabetes & Obesity in South Asians (PODOSA) is one of the first community-based, randomised lifestyle intervention trials in a UK South Asian population. The main trial results will be submitted for publication during 2013. Trial registration Current controlled trials ISRCTN25729565 (http://www.controlled-trials.com/isrctn/).

P2-21 Ethnic inequalities in myocardial infarction incidence, interventions and survival in Scotland: the Scottish Health and Ethnicity Linkage Study (SHELS)

Introduction Ethnic variations in coronary heart disease are large with a 50–70% excess consistently observed in South Asians. It is not clear whether this is attributable to increased incidence, poor survival, or both. We compared incidence and outcome of first acute myocardial infarction (AMI) by ethnic group in Scotland in relation to cardiac intervention uptake, socioeconomic factors and proximity to hospital. Methods We used linkage methods to combine ethnicity data from those aged ≥30 years of age in the 2001 Scottish Census with records of subsequent hospital discharges and deaths between 1 May 2001 and 30 April 2008. We compared incidence (death or discharge) and case fatality following first AMI by ethnic group using the White Scottish as the standard comparison population. Results AMI incidence rates were highest among Pakistani and lowest for Chinese, Other White British and Other White ethnic groups. Adjustment for highest educational qualification attenuated differences between White Scottish and other White groups but did not fully explain the excess in the Pakistani group. Pakistani women had lower HRs for death after AMI partly explained by shorter travel time to hospital. We found no evidence for lower uptake of cardiovascular procedures in Indians and Pakistanis. Conclusions The known elevated coronary heart disease risk in South Asians principally reflects increased incidence in Pakistanis emphasising the need for aggressive management of modifiable cardiovascular risk factors. Pakistani women were protected from case fatality in part by their closer proximity to hospital and not increased uptake of interventional procedures.

P22 A proposed World Council on Epidemiology and Causation: summary of feedback and an international workshop

Background Rigorous evaluation of associations in epidemiology is essential. There is a precedent in making judgements on associations in the monographs of the International Agency for Research on Cancer, however, only the carcinogenic effects of exposures are examined. A proposal to set up a World Council of Epidemiology and Causality (WCEC) to do this for all outcomes has been developed, published in outline, and discussed briefly at a previous SSM Pemberton lecture. The aim of this presentation is to summarise recent feedback on this proposal, particularly at an international workshop. The published and informal written feedback prior to the workshop and workshop discussions are summarised. Methods The idea of a WCEC was debated at a workshop at the International Epidemiology Association’s (IEA) 20th World Congress of Epidemiology, 2014. The objective was both to debate the idea and set out further questions and next steps. The workshop consisted of a presentation followed by discussion in five groups. Notes were made for each subgroup. These were edited by the facilitator, the author, and re-edited following feedback from the facilitators. Other feedback was read and summarised. Results The idea of a WCEC was perceived as potentially valuable. Future discussions should involve a wide range of partners (identified). WCEC should seek to absorb the best practice from organisations working on causality. Following more detailed discussions, including the development of a costed strategic plan, a small, central, independent office should be established to develop a work agenda and the necessary collaborations. The long term aim would be to have a distributed model of working. One or a few important causal topics should be chosen to develop the work, as exemplars. Long term priorities will need to be decided in engagement with potential users of outputs/recommendations arising. Funding needs to be identified for this developmental phase, preferably from one major and several supporting sources. Guidelines on causation, including on publication standards, should be developed by WCEC and its partners. While the focus of the WCEC will be on epidemiological and related type of evidence, the causal concepts and approaches will need to draw on a wide range of contributing disciplines. A committee of 8–12 people including representatives of organisations that have developed causal statements should be formed to move the above ideas forward. Conclusion Feedback indicates that the WCEC idea, notwithstanding many challenges, has promise and deserves more debate. The preferred model is for a small independent body working closely with relevant partners with a distributed approach to tasks. Other recommendations will be summarised and contextualised given recent approaches in causal thinking in epidemiology.

P73 Ethnic and/or racial differences in incidence of prostate cancer since 2000: Systematic review

Background Prostate cancer is the second most common cancer in men. Ethnic differences in incidence have been studied, suggesting highest rates in Black men and lowest in Asian ethnic groups, but a systematic review has not been conducted. Ethnic differences in incidence of prostate cancer between White, South Asian, Black and Chinese men from the year 2000 onwards were systematically reviewed. Methods MEDLINE (1946–25th June 2014), EMBASE (1946–25th June 2014) and In Process MEDLINE databases were searched to identify relevant studies, supplemented by reference lists and citations of included studies. Population based original research studies comparing incidence of prostate cancer between two or more of the ethnic groups in question (Black, White, South Asian and Chinese) in the same country were included, provided they had been published after 2000. Papers were quality assessed using the STROBE checklist and data were extracted. Results 23 articles were included. 22 of 23 studies comparing Black and White men described increased incidence of prostate cancer in Black men (risk ratios 1.47–2.39). South Asians had lower rates than White men in 7 of 8 studies (risk ratios 0.29–1.41) while incidence in Chinese men was consistently lower than in White men in all 5 studies (risk ratios 0.48–0.85). Conclusion Our review confirmed that prostate cancer is most common in Black men. Chinese and South Asian groups had low incidence. These variations may influence screening protocols. Further investigation of the causal basis for these variations would be valuable.

PP54 Ethnic differences in Upper Gastrointestinal Disease in Scotland

Background There is a paucity of data assessing ethnic variations in upper gastrointestinal (GI) disease: we sought to study the incidence of upper GI diseases using adequate measure of ethnicity in Scotland. Methods Using the Scottish health and ethnicity linkage study (SHELS), linking NHS hospital admissions and mortality to the Scottish census 2001, we explored ethnic differences in incidence (2001-2010) of specific upper GI diseases (peptic ulcer disease, oesophagitis, gastritis, gallstones and pancreatitis) in Scotland. Risk ratios (RR) were calculated using Poisson regression with robust variance and multiplied by 100, by gender, adjusted for age and subsequently country of birth. The White Scottish population was the standard reference population (100). 95% confidence intervals (CI) were calculated to enable comparison and exclude 100 in the results below. Results The total numbers of first events within the 9 years period of interest (over almost 29 million of Person-Year (PY) at risk) was 44,612 for peptic ulcer, 102,706 for oesophagitis, 141,235 for gastritis, 87,556 for gallstones and 17,177 for pancreatitis. Looking at risk ratios for all specific upper GI diseases and compared to respectively White Scottish men and women, other White British and other White had a lower risk of upper GI diseases even after adjustment for country of birth. White Irish had an increased risk of upper GI diseases but not significant after adjustment for country of birth. There were consistent ethnic variations in non–White minority ethnic group even after adjustment for country of birth. Chinese men and other South Asian (SA) men and women had a 1.5 to 1.7 fold increased risk of peptic ulcer disease. Pakistani and Bangladeshi had a 1.3 to 2 fold increased risk of oesophagitis whereas Chinese had a lower risk (RR 63.5 [95% CI 50.2, 80.2] for men, 67.4 [51.6, 88.1] for women). South Asian had a 1.2 to 1.5 fold increased risk of gastritis whereas it was lower for men of African origin (65.6 [49.3, 87.3]). Gallstones was more incident in Chinese men (140.2 [117.5, 167.2]) and Pakistani women (131.3 [115,4, 149.4]). The later also had an increased risk of pancreatitis (151.7 [123.3, 186.6]). Conclusion This unique data allowing the comparison of specific upper GI diseases incidences between ethnic groups has shown major differences. Further exploration on risk factors and understanding of differences is needed to promote health equality.

PP06 Cardiovascular Risk Factor Patterns in Long-Settled Roma and Recently Settled Indian Populations

Background Linguistic and genetic evidence shows that Romani people, now numbering around 10-12 million in Europe, originate from North India. Romanis are thought to have migrated from North India around 10th-11th Century AD. Cardiovascular health is extremely poor in recently settled Indians living in Europe. Diabetes is also highly prevalent. As Romanis emigrated from India, we hypothesised their cardiovascular health would be similar to recently settled South Asians. The recent Indian migration of the 1950’s onwards comes 500 years after the Romani’s first movements into Europe. Methods This paper is not a systematic review but, background data were found by a search for abstracts using PubMed. Key search terms were Roma/Romani/Gypsy/Gipsy and/or health, cardiovascular health, genetics, linguistics, diabetes, stroke, Body Mass Index, maternal health and birth outcomes. In all over 70 abstracts were read, of which 30 were discarded due to lack of relevance to the specific review focus while 4 were discarded due to being unable to gain access to the journal. 36 papers were downloaded from online journals and from this 19 papers were used in final the review. The websites of the United Nations Development programme, the World Health Organisation, the Open Society Institute and the Roma Decade of Inclusion were examined. Grey literature was particularly valuable in drawing demographic data. The results use data from key papers which are compared to the best equivalent data available on the same topic of Indians living in the United Kingdom. Results Studies have shown Romanis to have higher levels of several cardiovascular risk factors when compared to local populations; these include diabetes (30% vs. 10%), central obesity (38% vs. 20%), hypertriglyceridemia (66% vs. 39%), smoking and raised BMI. Low birth weight and gestational age also mirror trends of the Indian ethnic origin population in the United Kingdom. Romanis in Europe are well documented to have a 10-15 year reduced average lifespan compared to the majority - the age distribution pyramid in fact more resembles a developing country pattern than that of industrialised countries. Conclusion Our findings demonstrate commonality of several cardiovascular risk factors – underlying reasons for this are discussed. This work potentially offers insights into the high rates of cardiovascular diseases in both populations. To our knowledge no previous work has examined the matter from this perspective.

OP83 Contribution of Behavioural Risk Factors and Socio-Economic Position to Mortality in British South Asian and European Adults: 17 year follow-up of the Newcastle Heart Project Cohort

Background British South Asians experience excess cardiovascular disease (CVD) morbidity and mortality. Evidence for this is often based on studies using place of birth as a proxy for ethnicity. We examined the contribution of CVD risk factors and socio-economic position (SEP) to mortality in Europeans and South Asians, who provided confirmation of their ethnicity. Methods South Asian and European origin individuals, aged 25–74 years, were recruited (April 1993 to March 1997). Ethnicity was determined by self-identified ancestry; at least 3 grandparents born in India, Pakistan or Bangladesh indicated South Asian ethnicity. Lifestyle, SEP, biochemical and anthropometric data were collected. Participants were mortality flagged with the NHS Medical Research Information Service. A lifestyle risk score, including BMI and self-reported physical activity, diet, smoking and alcohol consumption (range 0–5) was dichotomised to categorise a ‘healthy’ (score 0–2) or ‘unhealthy’ lifestyle (score 3–5). SEP was determined by the occupation of the head of the household. Age-adjusted hazard ratios (HR) for death were derived from Cox regression analyses. Results 817 Europeans and 684 South Asians were followed up for 12-17 years. Mean follow-up was 14.9 and 13.9 years for Europeans and South Asians respectively. 5 Europeans and 34 South Asians were lost to follow-up, most commonly because individuals were no longer NHS registered (2 Europeans, 27 South Asians). Mortality ratios, standardised to a Newcastle-upon-Tyne European population, for Europeans and South Asians were 76.5 and 60.3 respectively (z-test of significance for difference between ethnic groups, p = 0.168). 28% and 49% of European men and women respectively (chi-square for difference, p < 0.001), and 23% and 26% (South Asian men and women, NS) were classified as having a healthy lifestyle. Having an unhealthy lifestyle was significantly associated with mortality in European women only (HR 1.8; 95% CI 1.03, 3.25). SEP was associated with mortality in European women and South Asian men (HR for manual vs non-manual occupation 3.1 [1.3, 7.5] and 3.7 [1.4, 9.9] respectively). SEP attenuated the effects of lifestyle on mortality in further models. Conclusion No significant difference in SMR between Europeans and South Asians found at 12–17 years of follow-up, although in contrast to previous studies we report a higher SMR in Europeans than in South Asians. There was a trend towards higher mortality in those with a less healthy lifestyle, but this was statistically significant only in European women. Adjusting for SEP attenuated the relationship between lifestyle and mortality suggesting that both SEP and lifestyle influence mortality.