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
Introduction The 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...
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2021-02-01
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| author | Mary Barker Janis Baird K S Joseph Cindy-Lee Dennis Zulfiqar A Bhutta Prakesh S Shah Saumyadipta Pyne Nalini Singhal Murali Krishna Prabhat Jha Harshpal Singh Sachdev Kalyanaraman Kumaran Caroline H D Fall Stephanie Atkinson Stephen Lye Stephen G Matthews Daniel Sellen Ghattu V Krishnaveni Kumar Gavali Suryanarayana Manohar Prabhu Prasad Antonisamy Belavendra Ramaswamy Balasubramaniam Robert H J Bandsma Giriraj Ratan Chandak Elena M Comelli Sandra T Davidge Geoffrey L Hammond Sadhana R Joshi Kang Lee Patrick McGowan Pablo Nepomnaschy Vivek Padvetnaya Sirazul Ameen Sahariah Jacquetta Trasler Chittaranjan S Yajnik Marie-Claude Martin Nusrat Husain |
| author_facet | Mary Barker Janis Baird K S Joseph Cindy-Lee Dennis Zulfiqar A Bhutta Prakesh S Shah Saumyadipta Pyne Nalini Singhal Murali Krishna Prabhat Jha Harshpal Singh Sachdev Kalyanaraman Kumaran Caroline H D Fall Stephanie Atkinson Stephen Lye Stephen G Matthews Daniel Sellen Ghattu V Krishnaveni Kumar Gavali Suryanarayana Manohar Prabhu Prasad Antonisamy Belavendra Ramaswamy Balasubramaniam Robert H J Bandsma Giriraj Ratan Chandak Elena M Comelli Sandra T Davidge Geoffrey L Hammond Sadhana R Joshi Kang Lee Patrick McGowan Pablo Nepomnaschy Vivek Padvetnaya Sirazul Ameen Sahariah Jacquetta Trasler Chittaranjan S Yajnik Marie-Claude Martin Nusrat Husain |
| author_sort | Mary Barker |
| collection | DOAJ |
| description | Introduction The 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 analysis The 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 dissemination The 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 number ISRCTN20161479, CTRI/2020/12/030134; Pre-results. |
| format | Article |
| id | doaj-art-aba18a2583814c3daecf00ad26e09785 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-aba18a2583814c3daecf00ad26e097852024-11-17T09:45:13ZengBMJ Publishing GroupBMJ Open2044-60552021-02-0111210.1136/bmjopen-2020-045862Protocol 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) StudyMary Barker0Janis Baird1K S Joseph2Cindy-Lee Dennis3Zulfiqar A Bhutta4Prakesh S Shah5Saumyadipta Pyne6Nalini Singhal7Murali Krishna8Prabhat Jha9Harshpal Singh Sachdev10Kalyanaraman Kumaran11Caroline H D Fall12Stephanie Atkinson13Stephen Lye14Stephen G Matthews15Daniel Sellen16Ghattu V Krishnaveni17Kumar Gavali Suryanarayana18Manohar Prabhu Prasad19Antonisamy Belavendra20Ramaswamy Balasubramaniam21Robert H J Bandsma22Giriraj Ratan Chandak23Elena M Comelli24Sandra T Davidge25Geoffrey L Hammond26Sadhana R Joshi27Kang Lee28Patrick McGowan29Pablo Nepomnaschy30Vivek Padvetnaya31Sirazul Ameen Sahariah32Jacquetta Trasler33Chittaranjan S Yajnik34Marie-Claude Martin35Nusrat Husain36School of Health Sciences, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UKprofessor of public health and epidemiologyBC Children`s Hospital Research Institute, Vancouver, British Columbia, Canada3 Lawrence S. Bloomburg Faculty of Nursing, University of Toronto, Toronto, Ontario, CanadaCentre for Global Child Health, Hospital for Sick Children, Toronto, Canada2 Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada3University of Pittsburgh, Pittsburgh, USAPediatrics, University of Calgary, Calgary, Alberta, CanadaUrology, Post Graduate Institute of Medical Education and Research, Chandigarh, IndiaUniversity of Toronto Dalla Lana School of Public Health, Toronto, Toronto, ON M5T 3M7, CanadaPediatrics and Clinical Epidemiology, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, IndiaMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, Hampshire, UKMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UKPaediatrics, McMaster University, Hamilton, Ontario, CanadaSAMRC Developmental Pathways for Health Research Unit, Department of Paediatrics, University of the Witwatersrand, Johannesburg-Braamfontein, South AfricaLunenfeld-Tanenbaum Research Institute, Toronto, Ontario, CanadaDepartment of Nutritional Sciences, University of Toronto, Toronto, Ontario, CanadaMRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UKDepartment of Academics and Research, Vivekananda Memorial Hospital, Saragur, Karnataka, IndiaDepartment of Academics and Research, Vivekananda Memorial Hospital, Saragur, Karnataka, IndiaDepartment of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, IndiaDevelopment Support, Swami Vivekananda Youth Movement, Mysore, IndiaDepartment of Nutritional Sciences, University of Toronto, Toronto, Ontario, CanadaGenomic Research on Complex Diseases, CSIR - Centre for Cellular and Molecular Biology, Hyderabad, Telangana, IndiaDepartment of Nutritional Sciences, University of Toronto, Toronto, Ontario, CanadaDepartment of Obstetrics & Gynecology, University of Alberta, Edmonton, Alberta, CanadaDepartment of Cellular & Physiological Sciences, University of British Columbia, Vancouver, British Columbia, CanadaNutritional Medicine Division, Interactive Research School for Health Affairs, Bharati Vidyapeeth, Pune, IndiaDepartment of Applied Psychology and Human Development, OISE/University of Toronto, Toronto, Ontario, CanadaDepartment of Biological Sciences, University of Toronto Scarborough, Toronto, Ontario, CanadaFaculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, CanadaJindal School of Government and Public Policy, O.P. Jindal Global University, Sonipat, Haryana, IndiaReproductive Maternal Newborn Child and Adolescent Health and Nutrition, MAMTA Health Institute for Mother and Child, New Delhi, Delhi, IndiaDepartments of Pediatrics, Human Genetics, and Pharmacology and Therapeutics, McGill University, Montreal, Quebec, CanadaDiabetes Unit, King Edward Memorial Hospital and Research Centre, Pune, IndiaLunenfeld-Tanenbaum Research Institute, Toronto, Ontario, CanadaSchool of Medicine, The University of Manchester, Manchester, UKIntroduction The 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 analysis The 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 dissemination The 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 number ISRCTN20161479, CTRI/2020/12/030134; Pre-results.https://bmjopen.bmj.com/content/11/2/e045862.full |
| spellingShingle | Mary Barker Janis Baird K S Joseph Cindy-Lee Dennis Zulfiqar A Bhutta Prakesh S Shah Saumyadipta Pyne Nalini Singhal Murali Krishna Prabhat Jha Harshpal Singh Sachdev Kalyanaraman Kumaran Caroline H D Fall Stephanie Atkinson Stephen Lye Stephen G Matthews Daniel Sellen Ghattu V Krishnaveni Kumar Gavali Suryanarayana Manohar Prabhu Prasad Antonisamy Belavendra Ramaswamy Balasubramaniam Robert H J Bandsma Giriraj Ratan Chandak Elena M Comelli Sandra T Davidge Geoffrey L Hammond Sadhana R Joshi Kang Lee Patrick McGowan Pablo Nepomnaschy Vivek Padvetnaya Sirazul Ameen Sahariah Jacquetta Trasler Chittaranjan S Yajnik Marie-Claude Martin Nusrat Husain 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/2/e045862.full |
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