Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally—Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study
Autor: | Pablo A. Nepomnaschy, Jacquetta M. Trasler, Patrick O. McGowan, Ramaswamy Balasubramaniam, Saumyadipta Pyne, Stephen G. Matthews, K.S. Joseph, Janis Baird, Nalini Singhal, Marie-Claude Martin, Antonisamy Belavendra, Geoffrey L. Hammond, Sandra T. Davidge, Manohar Prabhu Prasad, Nusrat Husain, Prabhat Jha, Kumar Gavali Suryanarayana, Stephen J. Lye, Cindy-Lee Dennis, Kalyanaraman Kumaran, Giriraj R. Chandak, Daniel W. Sellen, Vivek Padvetnaya, Harshpal Singh Sachdev, Mary Barker, Robert H. J. Bandsma, Sadhana Joshi, Stephanie A. Atkinson, Zulfiqar A Bhutta, Kang Lee, Murali Krishna, Ghattu V. Krishnaveni, Prakesh S. Shah, Sirazul A. Sahariah, Caroline H.D. Fall, Chittaranjan S. Yajnik, Elena M. Comelli |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Adult
Rural Population medicine.medical_specialty Epidemiology Psychological intervention India Mothers Nutritional Status Environmental pollution preventive medicine 03 medical and health sciences 0302 clinical medicine Pregnancy Intervention (counseling) medicine Humans 030212 general & internal medicine Child Preventive healthcare Randomized Controlled Trials as Topic Community Health Workers business.industry Public health public health Infant General Medicine Middle Aged 3. Good health Local community Family medicine Child Preschool Medicine Female business Breast feeding 030217 neurology & neurosurgery |
Zdroj: | BMJ Open, Vol 11, Iss 2 (2021) BMJ Open |
ISSN: | 2044-6055 |
Popis: | 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. |
Databáze: | OpenAIRE |
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