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. 2021 Feb 16;11(2):e045862.
doi: 10.1136/bmjopen-2020-045862.

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

Kalyanaraman Kumaran  1   2 , Ghattu V Krishnaveni  2 , Kumar Gavali Suryanarayana  3   4 , Manohar Prabhu Prasad  3 , Antonisamy Belavendra  5 , Stephanie Atkinson  6 , Ramaswamy Balasubramaniam  4 , Robert H J Bandsma  7   8 , Zulfiqar A Bhutta  9   10 , Giriraj Ratan Chandak  11 , Elena M Comelli  12   13 , Sandra T Davidge  14 , Cindy-Lee Dennis  15   16 , Geoffrey L Hammond  17 , Prabhat Jha  18 , K S Joseph  19   20 , Sadhana R Joshi  21 , Murali Krishna  22 , Kang Lee  23 , Stephen Lye  24   25 , Patrick McGowan  26 , Pablo Nepomnaschy  27 , Vivek Padvetnaya  28 , Saumyadipta Pyne  29   30 , Harshpal Singh Sachdev  31 , Sirazul Ameen Sahariah  32 , Nalini Singhal  33 , Jacquetta Trasler  34   35 , Chittaranjan S Yajnik  36 , Janis Baird  2   37 , Mary Barker  2   37 , Marie-Claude Martin  24 , Nusrat Husain  38 , Daniel Sellen  39   40 , Caroline H D Fall  2 , Prakesh S Shah  41   42 , Stephen G Matthews  24   25
Affiliations

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

Kalyanaraman Kumaran et al. BMJ Open. .

Abstract

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.

Keywords: epidemiology; preventive medicine; public health.

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Conflict of interest statement

Competing interests: None of the authors declare any conflict of interest. The HeLTI Council of funders and WHO have required all Principal Investigators to complete annual Declarations of Interest and to commit to having no direct or indirect relations with the tobacco, arms and infant food industries during the course of the study.

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