Overview: EINSTEIN is led by Dr K Kumaran, MRC LEC and CSI Holdsworth Memorial Hospital, Prof Stephen Matthews, University of Toronto, Canada, and Dr Kumar Gavali, Swami Vivekananda Youth Movement, Mysore. Other key investigators are Dr Prakesh Shah and Dr Daniel Sellen, University of Toronto, Canada; GV Krishnaveni, CSI Holdsworth Memorial Hospital, Mysore, India; Balasubramaniam Iyer, Swami Vivekananda Youth Movement, Mysore; Giriraj R Chandak, Centre for Cellular and Molecular Biology, Hyderabad; Prof Caroline Fall, Dr Sarah Kehoe and Prof Mary Barker, MRC LEC. The HeLTI programme is a joint initiative funded by the Canadian Institutes of Health Research (CIHR) and national research funding agencies in India, South Africa and China, in collaboration with the WHO. There are four separate but harmonised intervention studies being implemented in Mysore (India), Soweto (Johannesburg, South Africa), Shanghai (China), and three provinces in Canada. All are based on DOHaD concepts and focus on developing evidence-based multi-faceted interventions that span from preconception across pregnancy and into the postnatal period with the goal of improving maternal, infant and child body composition, cardiometabolic health and neurodevelopment. The Indian study is called EINSTEIN (Early Interventions to Support Trajectories for Healthy Life in India).
Objective: To test the hypothesis that integrated multi-faceted interventions administered pre-conceptionally and at appropriate points across the early life-course (fetal life, infancy and childhood) will reduce childhood adiposity, improve cardiometabolic health, and improve child development outcomes.
Methods: The Indian study, EINSTEIN, is a community-based, cluster randomised intervention set in rural Mysore, South India, with three arms (pre-conception, pregnancy and controls) with individual villages forming the basis for the clusters. Villages will be randomised to one of three groups:
- Group 1 (Pre-conception arm): 1) Daily maternal multiple micronutrient supplements (UNIMMAP) preconceptionally, throughout pregnancy, and during breast feeding; 2) Lifestyle behaviour change support, using Healthy Conversation Skills (HCS; developed in Southampton by Mary Barker and her team) to support behaviour change and to underpin all communication between CHWs and participants. The aim will be to promote a diverse diet, achievement of a normal body weight, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, handwashing, use of safe water for infant feeding after six months, full infant vaccination, avoidance of environmental pollutants including indoor cooking smoke; 3) Learning Through Play Plus (LTP Plus) a group parenting programme, integrated with a cognitive behaviour therapy intervention (Thinking Healthy Programme) designed to address maternal perinatal depression, improve parenting skills and enhance child development.
- Group 2 (Pregnancy arm): Women in this group will receive the same package of interventions described above, but starting only after they become pregnant, which in practice will mean from late in the first trimester.
- Group 3 (Control arm): Women in this group will receive standard care which includes encouraging vaccinations (two doses of tetanus toxoid) during pregnancy, provision of 100 tablets of iron and folate, and promoting institutional delivery. They will have a similar number of contact sessions with CHWs, but these will not be trained in our behaviour change or parenting interventions. Women will receive standard advice on healthy diet and lifestyle during pregnancy and postnatally, supported by information leaflets (mainly pictorial and using simple language); these will include advice on breast feeding, immunisations, and infant weaning foods.
Outcomes: The primary outcome is fat mass index at five years of age in the children. Major secondary outcomes include fasting glucose, systolic blood pressure and infant/child development outcomes. There will also be intermediate, process and economic outcomes.
The study is currently in the formative research phase and will be recruiting women in late 2019.