IntroductionSouth Asians are at high risk of type 2 diabetes (T2D). We assessed whether intensive family-based lifestyle intervention leads to significant weight loss, improved glycaemia and blood pressure in adults at elevated risk for T2D.MethodsThis cluster randomised controlled trial (iHealth-T2D) was conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. We included 3684 South Asian men and women, aged 40–70 years, without T2D but with raised haemoglobin A1c (HbA1c) and/or waist circumference. Participants were randomly allocated either to the family-based lifestyle intervention or control group by location clusters. Participants in the intervention received 9 visits and 13 telephone contacts by community health workers over 1-year period, and the control group received usual care. Reductions in weight (aim >7% reduction), waist circumference (aim ≥5 cm reduction), blood pressure and HbA1C at 12 months of follow-up were assessed. Our linear mixed-effects regression analysis was based on intention-to-treat principle and adjusted for age, sex and baseline values.ResultsThere were 1846 participants in the control and 1838 in the intervention group. Between baseline and 12 months, mean weight of participants in the intervention group reduced by 1.8 kg compared with 0.4 kg in the control group (adjusted mean difference −1.10 kg (95% CI −1.70 to −1.06), p<0.001). The adjusted mean difference for waist circumference was −1.9 cm (95% CI −2.5; to 1.3), p<0.001). No overall difference was observed for blood pressure or HbA1c. People who attended multiple intervention sessions had a dose-dependent effect on waist circumference, blood pressure and HbA1c, but not on weight.ConclusionAn intensive family-based lifestyle intervention adopting low-resource strategies led to effective reduction in weight and waist circumference at 12 months, which has potential long-term benefits for preventing T2D. A higher number of attended sessions increased the effect on waist circumference, blood pressure and HbA1c.Trial registration numberEudraCT: 2016-001350-18; ClinicalTrials.gov: NCT02949739.

Background: Sri Lanka lacks robust estimates of hypertension (HTN) prevalence owing to few national studies, hindering optimization of control strategies. Evidence on how the revised 2017 American College of Cardiology/American Heart Association (ACC/AHA) HTN definition affects prevalence in low-and middle-income countries (LMICs) is also limited. Objectives:To make robust estimates of HTN prevalence in the Sri Lankan adult population, and to assess impact of the ACC/AHA 2017 definitions. Methods: Data were sourced from the 2018-2019 first wave of the Sri Lanka Health and Ageing Study (SLHAS), a nationally representative longitudinal study of the noninstitutionalized adult population. After excluding those with missing data and aged <18 years, 6,342 participants (95.1%) were included in the analysis. HTN was defined using either the traditional threshold of systolic BP (SBP) ≥140 mmHg or a diastolic BP (DBP) ≥90 mmHg, or the ACC/AHA 2017 threshold of SBP ≥130 mmHg or DBP ≥80 mmHg, or if taking antihypertensive medication.Results: Estimated prevalence of HTN in all Sri Lankan adults was 28.2% using the traditional definition, and it doubled to 51.3% when applying the ACC/AHA 2017 definition. Of those classified as hypertensive according to the older and ACC/AHA 2017 definitions, 53.4% and 31.2%, respectively, were previously diagnosed. Of the 23.2% of adults reclassified as hypertensive by the ACC/AHA 2017 definition, 16.6% had a history of CVD or diabetes. Increased prevalence was associated with urban residence, socioeconomic status, obesity, and Muslim ethnicity. Prevalence increased with age, but the increase was steeper in women from their 30s. Conclusions:Nearly one in three adult Sri Lankans are hypertensive, requiring antihypertensive treatment. Applying the ACC/AHA 2017 definitions almost doubles numbers, but many of those reclassified would require treatment under recent WHO guidelines. Study findings also suggest that design effects in HTN surveys may be higher than usually assumed. 2 Rannan-Eliya et al.

Background People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB approval 16/WM/0171 Trial registration EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.govNCT02949739. Registered on 31 October 2016, First posted on 31/10/2016.

Background South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. Methods The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. Discussion The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. Ethics and dissemination The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations. Trial registration EudraCT 2016–001,350-18. Registered on 14 April 2016. ClinicalTrials.gov NCT02949739. Registered on 31 October 2016.

Background: Although indications suggest that Sri Lanka is facing serious mental health challenges within its diverse populations, the extent of the problem is poorly quantified and even tools required to explore its nature are unavailable. The present study tests the psychometric equivalence of the PHQ-9, a widely used measure of depression, across two translated versions to Sinhala (Sinhala-English) and Tamil (Tamil-English) languages. It also tests equivalence across different demographic groups. Methods: The study uses data from a nationally representative sample of 6,444 individuals, from the 2018-19 Wave 1 of the Sri Lanka Health and Ageing Study, who completed the PHQ-9 along with other measures of health and wellbeing. For analysing the data, standardized process of measurement invariance testing was performed using multigroup confirmatory factor analysing technique. Results: Results indicated equivalence across the two translated versions, and across gender, ethnicity, level of education, and socioeconomic status. Configural, scalar and strict invariances were established successfully for each variable. Conclusions: The translated PHQ-9 tools were found to perform psychometrically similarly across diverse populations in Sri Lanka. These versions of the PHQ-9 can therefore be used for screening of depressive symptoms and research purposes in Sri Lanka irrespective of population characteristics in terms of language, gender, ethnicity, level of education or socioeconomic status without concerns over whether they are equivalent.