Early Interventions to Support Trajectories for healthy lifE in India:
The EINSTEIN Study
Principal Investigators: Kalyanaraman Kumaran and Stephen Matthews
The health and economic burden of non-communicable diseases (NCDs) is increasing rapidly globally and falls disproportionally on low- and middle-income countries (LMICs). In India, an estimated 65 million people have diabetes and a further 77 million are pre-diabetic. Unchecked, the population with diabetes is expected to reach 109 million by 2035. The rising burden of cardiometabolic disease is accompanied by a growing burden of mental health disorders; 13% of young people aged 1-16 years in India experience mental health disorders. Undernutrition remains a significant problem: in children under 5, the estimated prevalence of stunting is 48%; wasting 20%; underweight 43%; and anaemia 69%. In women aged 15-49 years, 33% are underweight while 55% are anaemic. These factors are reflected in a high prevalence of low birth weight (~25% of babies born in India each year). Low birth weight, poor infant nutrition, and rapid childhood weight gain and obesity are well-established risk factors for poor health trajectories and development of NCDs in later life. Rates of obesity in children and adults are also increasing in India; 19% of children and adolescents and 15% of women of reproductive age are overweight or obese.
The HeLTI research hypothesis is that integrated interventions administered pre-conceptionally and at appropriate points across the life-course (pregnancy, infancy and early childhood) will reduce childhood adiposity, improve cardiovascular and metabolic health, and improve child neurodevelopmental outcomes. The EINSTEIN study recruits women of reproductive age and offers a longitudinal multi-faceted intervention delivered by community health workers comprising of: a) multiple micronutrients; b) a group parenting program to address maternal depression and improve child development; c) hygiene and infection prevention measures; and d) reduction of environmental pollution exposure. Interventions are underpinned by a lifestyle behavior change strategy.
The primary outcome is adiposity in children at 5 years of age measured by fat mass index. Other key outcomes at 5 years include: overweight and obesity, glucose metabolism, blood pressure, and infant/child neurodevelopmental outcomes. In addition, the study will track a host of intermediate and process outcomes, as well as the efficacy, cost-effectiveness, and acceptability of the intervention package, compared with standard care. The study will also report on the relative costs and benefits of commencing the intervention in early pregnancy compared with the preconception period.
The study will benefit from outstanding intellectual and infrastructure resources in India and Canada, built over years of research and community engagement. The Indian and Canadian teams bring together researchers from 18 institutions with complementary expertise in DOHaD research, intervention cohorts, longitudinal studies, data management and knowledge translation/policy development. These strengths combined with strong collaborations with knowledge users and health policy experts will ultimately allow implementation and scale-up of the most effective interventions.
HeLTI India - The EINSTEIN Study
- Target Enrolment Size: 6,000
- Trial Formative Research Started: June 2018
- Date Enrolment Started (main trial): February 2021
- Target Recruitment Completion: March 2023
- Expected Completion of Trial: 2029
- Current Enrolment (as of April 2022): 2,044
- Live Births (as of April 2022): N/A