A controlled trial of the effectiveness of a diabetes education programme in a multi-ethnic community in Glasgow [ISRCTN28317455].

BACKGROUND: Epidemiologic data have shown that the prevalence of Type 2 diabetes varies with ethnic origin. Type 2 diabetes is up to four times more common in British South Asians than in the indigenous white population. The aim of this study was to develop a culturally appropriate educational intervention programme for South Asians with Type 2 diabetes. We then investigated whether this intervention could produce an improvement, and finally whether any improvement was greater than background changes in knowledge in comparison groups. METHODS: A multi-site prospective, randomised controlled study was conducted in all day care centres and three general practice registers with high proportion patients from different ethnic minority groups in Glasgow, Scotland. The intervention consisted of 18 educational sessions in 6 separate programmes. A modified questionnaire was used to measure the knowledge, attitudes, and practice of diabetes before and after intervention. RESULTS: Baseline assessment showed that Indian and Pakistani subjects had less knowledge about diabetes, regarded the disease less seriously, and had a lesser understanding of the relationship between control and complications than the white population. No differences in initial responses were found between those who completed the second assessment and those who did not. The intervention group showed significant improvements in scores for Knowledge (+12.5%); Attitudes toward seriousness (+13.5%), complications (+8.1%), Practice (+20.0%). However there were also changes in the ethnic control group scores; respectively +5.0%, +16.3% (significant P < 0.001), +1.5%, +1.7%. The single white control group also showed some improvements; respectively +12.2%, +12.4% (P = 0.04), +6.0%, +25.0% (P = 0.007), but the differences in improvement between these two control groups were not significant. Overall, the improvement seen was similar in both intervention and ethnic control groups and there was no significant difference in the amount of change (P = 0.36 CI -0.9 to +2.6). CONCLUSION: This study has shown that conducting a culturally-competent educational intervention in patients with Type 2 diabetes from ethnic minority groups is feasible and can improve their knowledge and attitudes and practice. However there was no net benefit compared with the control group.

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.

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/).

Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians).

BACKGROUND: Despite the growing emphasis on the inclusion of ethnic minority patients in research, there is little published on the recruitment of these populations especially to randomised, community based, lifestyle intervention trials in the UK. METHODS: We share our experience of recruitment to screening in the PODOSA (Prevention of Diabetes and Obesity in South Asians) trial, which screened 1319 recruits (target 1800) for trial eligibility. A multi-pronged recruitment approach was used. Enrolment via the National Health Service included direct referrals from health care professionals and written invitations via general practices. Recruitment within the community was carried out by both the research team and through our partnerships with local South Asian groups and organisations. Participants were encouraged to refer friends and family throughout the recruitment period. RESULTS: Health care professionals referred only 55 potential participants. The response to written invitations via general practitioners was 5.2%, lower than reported in other general populations. Community orientated, personal approaches for recruitment were comparatively effective yielding 1728 referrals (82%) to the screening stage. CONCLUSIONS: The PODOSA experience shows that a community orientated, personal approach for recruiting South Asian ethnic minority populations can be successful in a trial setting. We recommend that consideration is given to cover recruitment costs associated with community engagement and other personalised approaches. Researchers should consider prioritising approaches that minimise interference with professionals' work and, particularly in the current economic climate, keep costs to a minimum. The lessons learned in PODOSA should contribute to future community based trials in South Asians. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25729565.

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.