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Risky alcohol use is a major public health problem globally and in Sri Lanka. While a reduction in alcohol consumption can result in physical, mental, and social benefits, behaviour change is difficult to achieve. Effective, context-adapted interventions are required to minimise alcohol-related harm at a community level. THEATRE is a complex, community-based intervention evaluating whether a promising Sri Lankan pilot study that utilised arts-based research to moderate alcohol use can be scaled up. While the scaled-up pilot study protocol is presented elsewhere, the aim of this protocol paper is to describe the intervention programme theory and evaluation design, and modifications made to the study resulting from COVID-19 and the financial crisis. Drawing on the Behaviour Change Wheel (BCW) and Theoretical Domains Framework, behaviour change theories are presented with potential pathways to guide implementation and evaluation. Alcohol consumption patterns and context of drinking is detailed. The multifaceted intervention targets individuals and communities using arts-based interventions. Four of nine BCW functions are employed in the design of the intervention: education, persuasion, modelling and enablement, and training. Modifications made to the study due to COVID-19 and the financial crisis are described. Ethical approval was obtained from the Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and Feb 2022) and the University of Sydney (2019/006). Findings will be disseminated locally to community members and key stakeholders and via international peer-reviewed publications.

Introduction: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19., Methods and Analysis: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes., Ethics and Dissemination: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies., Trial Registration: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Prevention of cardiovascular disease and diabetes is a priority in low- and middle-income countries, especially in South Asia where these are leading causes of morbidity and mortality. The metabolic syndrome is a tool to identify cardiometabolic risk, but the validity of the metabolic syndrome as a clinical construct is debated. This study tested the existence of the metabolic syndrome, explored alternative cardiometabolic risk characterisations, and examined genetic and environmental factors in a South Asian population sample., Methods: Data came from the Colombo Twin and Singleton follow-up Study, which recruited twins and singletons in Colombo, Sri Lanka, in 2012-2015 (n = 3476). Latent class analysis tested the clustering of metabolic syndrome indicators (waist circumference, high-density lipoprotein cholesterol, triglycerides, blood pressure, fasting plasma glucose, medications, and diabetes). Regression analyses tested cross-sectional associations between the identified latent cardiometabolic classes and sociodemographic covariates and health behaviours. Structural equation modelling estimated genetic and environmental contributions to cardiometabolic risk profiles. All analyses were stratified by sex (n = 1509 men, n = 1967 women)., Results: Three classes were identified in men: 1) "Healthy" (52.3%), 2) "Central obesity, high triglycerides, high fasting plasma glucose" (40.2%), and 3) "Central obesity, high triglycerides, diabetes" (7.6%). Four classes were identified in women: 1) "Healthy" (53.2%), 2) "Very high central obesity, low high-density lipoprotein cholesterol, raised fasting plasma glucose" (32.8%), 3) "Very high central obesity, diabetes" (7.2%) and 4) "Central obesity, hypertension, raised fasting plasma glucose" (6.8%). Older age in men and women, and high socioeconomic status in men, was associated with cardiometabolic risk classes, compared to the "Healthy" classes. In men, individual differences in cardiometabolic class membership were due to environmental effects. In women, genetic differences predicted class membership., Conclusion: The findings did not support the metabolic syndrome construct. Instead, distinct clinical profiles were identified for men and women, suggesting different aetiological pathways., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Harber-Aschan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Biobanks are a valuable resource for creating advancements in science through cutting-edge omics research. Twin research methods allow us to understand the degree to which genetics and environmental factors contribute to health outcomes., Methods: The Sri Lankan Twin Registry biobank (SLTR-b) was established in 2015 as part of Colombo Twin and Singleton Follow-up Study. Venous blood and urine were collected from twins and comparative sample of singletons for clinical investigations and biobanking., Results: The SLTR-b currently houses 3369 DNA and serum samples. Biobank specimens are linked to longitudinal questionnaire data, clinical investigations, anthropometric measurements, and other data., Discussion: The SLTR-b aims to address gaps in health and genetics research. It will provide opportunities for academic collaborations, local and international, and capacity building of future research leaders in twin and omics research. This paper provides a cohort profile of the SLTR-b and its linked data, and an overview of the strategies used for biobanking., Competing Interests: Prof. Matthew Hotopf is the Principal Investigator of RADAR-CNS jointly funded the European Commission, the European Federation of Pharmaceutical Industries and Associations; includes research grants from Janssen, UCB, Merck, Biogen, and Lundbeck., (© The Author(s) 2020.)

Introduction: Worldwide, 10%-20% of children and adolescents experience mental health conditions. However, most such disorders remain undiagnosed until adolescence or adulthood. Little is known about the factors that influence mental health in children and adolescents, especially in low and middle-income countries (LMIC), where environmental threats, such as poverty and war, may affect optimal neurodevelopment. Cohort studies provide important information on risks and resilience across the life course by enabling tracking of the effects of early life environment on health during childhood and beyond. Large birth cohort studies, including twin cohorts that can be aetiologically informative, have been conducted within high-income countries but are not generalisable to LMIC. There are limited longitudinal birth cohort studies in LMIC., Methods: We sought to enhance the volume of impactful research in Sri Lanka by establishing a Centre of Excellence for cohort studies. The aim is to establish a register of infant, child and adolescent twins, including mothers pregnant with twins, starting in the districts of Colombo (Western Province) and Vavuniya (Northern Province). We will gain consent from twins or parents for future research projects. This register will provide the platform to investigate the aetiology of mental illness and the impact of challenges to early brain development on future mental health. Using this register, we will be able to conduct research that will (1) expand existing research capacity on child and adolescent mental health and twin methods; (2) further consolidate existing partnerships and (3) establish new collaborations. The initiative is underpinned by three pillars: high-quality research, ethics, and patient and public involvement and engagement (PPIE)., Ethics and Dissemination: Ethical approval for this study was obtained from the Ethics Review Committee of Sri Lanka Medical Association and Keele University's Ethical Review Panel. In addition to journal publications, a range of PPIE activities have been conducted., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objectives: Social capital which implies 'features of social organisation, such as trust, norms and networks that can improve the efficiency of society by facilitating coordinated actions' is rarely assessed in relation to maternal health in low/middle-income countries (LMICs). A main reason for this research gap could be the unavailability of a specific tool to measure social capital in pregnancy. The study developed and validated an instrument to measure social capital among pregnant women., Setting: We developed the tool based on World Bank Social Capital Assessment Tool and its adaptations identified as applicable to LMIC from an initial systematic review. The study was conducted in Anuradhapura district in the North Central Province of Sri Lanka. Validation process was conducted in urban, rural and resettled communities., Participants: Study participants of the cognitive validation included pregnant women from the three communities, and an expert panel including a social scientist, methodological expert, subject expert, public health officers. The psychometric validation was performed on 439 pregnant women permanently residing in the three communities., Results: The 24-item Low and middle income countries Social Capital Assessment Tool for Maternal Health (LSCAT-MH) demonstrated high internal consistency (Cronbach's α=0.94). Factor analytical methods suggested a four-factor model of (1) neighbourhood networks (structural bonding), (2) domestic and neighbourhood cohesion (cognitive bonding), (3) social contribution and (4) social participation (structural bridging). Concurrent validity with antenatal mental ill health was confirmed through a negative correlation with the Edinburgh Postpartum Depression Scale. Test-retest reliability was high with intraclass correlation of 0.71 and a Pearson correlation of 0.83., Conclusion: The LSCAT-MH is a psychometrically valid and reliable tool to measure social capital in pregnancy. Predictive validity was not tested as the study was not a longitudinal follow-up., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Describe sleep duration in adult Sri Lankans and determine the bias and agreement of self-report and actigraphic assessments., Design: Validation sub-study nested within the Colombo Twin and Singleton Study (2012-2015)., Setting: Colombo, Sri Lanka., Participants: 175 adults with actigraphy, randomly selected from 3497 participants with self-reported sleep assessed in a population-based cohort., Measurements: Self-reported sleep duration, ascertained by the Pittsburgh Sleep Quality Index (PSQI), was compared to a minimum of four days of actigraphy. Bias and agreement were assessed using the Bland-Altman method and a novel application of criterion cut-point analysis. Objective measurements of wake after sleep onset (WASO) and sleep efficiency were evaluated., Results: Sri Lankans have short sleep duration; averaging 6.4h (SD 1.5) self-reported and 6.0h (SD 0.9) actigraphically. Poor sleep quality was prevalent with an average WASO of 49 min., and sleep efficiency <85%. Bias was observed, with self-report consistently over-reporting sleep on average by 27.6 min (95% CI: -0.68, -0.24) compared to objective measures, but wide individual variation in disagreement, ranging from over-reporting by 3.34h to under-reporting by 2.42h. A criterion cut-point method also failed to define agreed definitions of short and long sleep duration., Conclusions: Sleep in Sri Lankan adults, whether measured subjectively or objectively, is of short duration and suboptimal objective quality by High Income Country consensus standards. Given the high cardiometabolic morbidity in Sri Lanka and poor measurement agreement observed, this warrants further investigation and supports the need for culturally appropriate, reliable, and valid assessment for analytic epidemiology in non-Western settings., (Copyright © 2018 National Sleep Foundation. All rights reserved.)

The Sri Lankan Twin Registry (SLTR), established in 1997, is a unique resource for twin and genetic research in a low- and middle-income country (LMIC). It comprises of a volunteer cohort of 14,120 twins (7,060 pairs) and 119 sets of triplets, and a population-based cohort of 19,040 (9,520 pairs) twins and 89 sets of triplets. Several studies have been conducted using this registry, including the Colombo Twin and Singleton Study (CoTaSS 1; 4,387 twins, 2,311 singletons), which have explored the prevalence and heritability of a range of psychiatric disorders as well as gene-environmental interplay. Currently, a follow-up study (CoTaSS 2) of the same cohort is underway, looking at the prevalence and interrelationship of key cardiovascular and metabolic risk markers (e.g., metabolic syndrome). A significant feature of CoTaSS 2 is the establishment of a biobank. Current SLTR work is extending beyond mental health and the interface between mental and physical health to new horizons, extending collaborations with the wider global twin research community. Ethics and governance have been given special emphasis in the initiative. Capacity building and public engagement are two crucial components. Establishment of a state-of-the-art genetic laboratory was a major accomplishment. SLTR is a classic showcase of successful North-South partnership in building a progressive research infrastructure in a LMIC.

Little is known about the prevalence and etiology of tobacco use in Asian populations. This study aims to test whether the finding of substantial heritability for tobacco-related phenotypes in Western populations is generalizable to developing countries. The twin method was used to estimate the relative contribution of genetic and environmental influences on nicotine-related phenotypes. Participants were selected from the population based Sri Lankan Twin Registry. The Composite International Diagnostic Interview was administered to 1,804 male individuals to assess five phenotypes: nicotine use; desire and unsuccessful attempts to quit smoking; subjective feeling of being tobacco dependent; and two DSM-IV diagnoses; nicotine dependence and nicotine withdrawal. Almost one-third of the male twins were life-time smokers. The genetic results were consistent with the previously reported findings from Western and Chinese populations, in that the nicotine use traits were significantly heritable, with environmental influences being of the non-shared nature. The results derived from the Causal Contingent Common pathway model (CCC) supported previous findings that show that liabilities to regular smoking and subsequent problem smoking have both shared and specific genetic influences.

Background: Somatic symptoms often co-occur with psychological symptoms but this overlap is poorly understood. Some aspects of this overlap differ in the South Asian context, but it is not clear whether this is a reporting effect or an underlying difference in experienced illness., Methods: Home interviews were administered to 4,024 twins randomly selected from a population-based twin register in the Colombo district of Sri Lanka (the CoTASS study). These included assessments of psychological, somatic and fatigue symptoms. The data were analyzed using factor analytic and quantitative genetic approaches., Results: Confirmatory factor analysis showed that the symptoms from the three scales represented three separate dimensions, rather than all tapping into a single dimension. However, familial correlations among the data were most consistent with a common pathway model. This implies that a portion of the underlying vulnerability is common across psychological, fatigue and somatic symptoms. There were sex differences in the etiology of this model, with shared environmental and genetic influences playing different roles in men and women., Conclusions: There is a complex etiological relationship between psychological, fatigue and somatic symptoms. This is similar in Sri Lanka to Western countries, but there may be a greater influence from the family environment, suggesting that care needs to be taken when generalizing research findings between countries. People who complain of certain fatigue or somatic symptoms may well also have psychological symptoms, or may have genetic or environmental vulnerabilities to such problems.

Background: Fatigue is a common symptom in Western high-income countries but is often medically unexplained and little is known about its presentation in other populations., Aims: To explore the epidemiology and aetiology of fatigue in Sri Lanka, and of its overlap with depression., Method: A total of 4024 randomly selected twins from a population-based register in Sri Lanka (Colombo district) completed home interviews including the Chalder Fatigue Questionnaire., Results: The prevalence of fatigue was similar to that in other countries, although prolonged fatigue may be less common. There was substantial comorbidity with a screen for lifetime depression. Non-shared environmental factors made the largest contributions, although genetic/family factors also contributed. The aetiology appeared consistent across the spectrum of severity., Conclusions: The aetiology of fatigue is broadly similar in Sri Lanka and Western high-income countries. Abnormal experiences of fatigue appear to be the extreme form of more common fatigue, rather than representing independent entities with different genetic or environmental risk factors.

Background: It is important to understand the nature of depression in non-Western and lower-income countries, but little such research exists. This study aimed to examine the characteristic features of depression in Sri Lanka, and to identify environmental risk factors., Methods: Depression diagnoses, symptoms and impairment were measured using the Composite International Diagnostic Interview, in a population-based sample of 6014 twins and non-twins in the Colombo region of Sri Lanka (the CoTASS sample). Socio-demographic factors and environments were assessed via questionnaires., Results: Lifetime-ever depression was reported in 6.6% of participants, rising to 11.2% if the functional impairment criterion was excluded. The symptom profile of depression and its socio-demographic associations were very comparable to those in Western and more economically developed countries, whether functional impairment was included in the definition or not. Standard of living was independently associated with depression, especially among men at the more deprived end of the distribution. Specific associations were found with both financial wellbeing and material characteristics of the home environment., Limitations: The observational associations identified are cross-sectional, so do not necessarily imply causal links., Conclusions: Aside from a lower prevalence, depression is very similar in this predominantly urban Sri Lankan sample to higher-income, Western countries, and may be under-identified due to a relatively low cultural appropriateness of the assessment of impairment. Under Sri Lanka's cultural and environmental context, certain aspects of the material environment are associated with depression among certain segments of society, perhaps because of their particular link to social status and social networks., (Copyright 2009 Elsevier B.V. All rights reserved.)

Background: There is very little genetically informative research identifying true environmental risks for psychiatric conditions. These may be best explored in regions with diverse environmental exposures. The current study aimed to explore similarities and differences in such risks contributing to depression and fatigue., Methods: Home interviews assessed depression (lifetime-ever), fatigue and environmental exposures in 4,024 randomly selected twins from a population-based register in the Colombo district of Sri Lanka., Results: Early school leaving and standard of living showed environmentally-mediated effects on depression, in men. In women, life events were associated with depression partly through genetic pathways (however, the temporal order is consistent with life events being an outcome of depression, as well as the other way around). For fatigue, there were environmentally mediated effects (through early school leaving and life events) and strong suggestions of family-environmental influences., Conclusions: Compared to previous studies from higher-income countries, novel environmentally-mediated risk factors for depression and fatigue were identified in Sri Lanka. But as seen elsewhere, the association between life events and depression was partially genetically mediated in women. These results have implications for understanding environmental mechanisms around the world.

Background: Susceptibility to depression results from genetic and non-familially shared environmental influences in high-income, Western countries. Environments may play a different role for populations in different contexts., Aims: To examine heritability of depression in the first large, population-based twin study in a low-income country., Method: Lifetime depression and a broader measure of depression susceptibility (D-probe) were assessed in 3908 adult twins in Sri Lanka (the CoTASS study)., Results: There were gender differences for the broad definition (D-probe), with a higher genetic contribution in females (61%) than males (4%). Results were similar for depression, but the prevalence was too low to estimate heritability for males., Conclusions: Genetic influences on depression in women appear to be at least as strong in this Sri Lankan sample as in higher-income countries. Conclusions are less clear for men but suggest a larger role for environments rather than genes. The nature as well as the magnitude of environmental influences may also differ across populations.

Background: The Sri Lankan twin registry is one of the first to be established in a developing country, and its design has ensured sampling from a wide range of environmental conditions. It thus has great potential to examine environmental and genetic influences on diverse phenotypes, including psychiatric disorders, in the context of a diversity of environmental exposures, which may not have been fully explored in previous twin studies in developed countries. This paper presents the rationale for the study, describes its context, and the methods for twin ascertainment and data collection., Methods: A population-based twin register was established in the Colombo district of Sri Lanka using infrastructure designed to periodically update the electoral register. We invited a subsample from this register to participate in the project on common mental disorders, using random ascertainment. A separate non-twin sample was randomly selected from the geographical areas where twins were found. Home interviewers collected diagnostic information on common mental disorders, as well as environmental exposures including life events, socio-economic conditions, and the impact of the civil war and the Tsunami of 2004., Results: We identified 19,302 individuals in the creation of the population based twin register. We randomly selected a subsample, of whom 4,387 were eligible to participate and 4,024 agreed to be interviewed (including data on 1,954 complete pairs of twins and 5 sets of triplets). Those who refused consent had a similar mean age and sex ratio to those who were interviewed. We invited 2,485 singletons to participate and 2,019 were interviewed., Conclusion: Initial exploration of the data suggests the samples are very representative of the Colombo district of Sri Lanka, so we have created a unique resource for understanding the influences on mental disorders in developing countries, and to compare to the influences found in developed countries.