IntroductionThe Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.Methods and analysisThe study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.Ethics and disseminationThe study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.Trial registration numberISRCTN20161479, CTRI/2020/12/030134; Pre-results.
The Healthy Life Trajectories Initiative programme is a ten-year joint initiative consisting of four separate but harmonised intervention studies in Mysore (India), Johannesburg (South Africa), Shanghai (China) and two provinces in Canada. They will test evidence-based multi-faceted interventions spanning from preconception into the postnatal period, to improve maternal, infant and child health, including cardiometabolic and neurocognitive well-being. Similar to the other studies, the India study was based on developmental origins of health and disease principles. However, it had to be adapted to fit in with the local socio-cultural context and government policy. We considered the contextual factors in our setting and undertook extensive engagement and formative work with the local community to develop the intervention package and plan delivery methods. This article describes the process we adopted to set up the India project, develop the intervention package and delivery methods.
Background: The COVID-19 pandemic has affected billions of lives across all countries precipitating an unprecedented demand for simultaneous curative, preventative, promotive, and curative services which has impacted the entire healthcare system. Even as it continues to rage across the globe, it is pertinent to learn from current experiences to build resilience into the system, especially for the vulnerable populations in rural areas.Methods: A retrospective cohort study of COVID-19 was conducted at COVID care centre in Vivekananda Memorial Hospital. A total of 136 COVID-19 confirmed patients were included in the study. Epidemiological and clinical profiles of patients were summarised. The association between risk factors and COVID-19 disease progression and patients’ outcomes at discharge were analysed and adjusted risk ratios were presented.Results: Out of the 136 patients, 128 were discharged uneventfully, 7 were referred to a higher centre because of disease progression and one patient died due to cardiac arrest. The study showed statistically significant association between age above 50 years and the presence of diabetes with COVID-19 disease progression. Delayed presentation for care also carried a higher risk of negative outcomes. Significant number of diabetics had derangement of their glycaemic control during the period of study.Conclusions: The study has highlighted the importance of ensuring essential non-COVID public health services, especially targeted follow-up of older adults, people with diabetes for their treatment adherence and early detection and treatment initiation of COVID-19 amongst them.
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