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Interventions in early life and through the lifecourse to prevent non-communicable diseases in later life in India

Early INterventions to Support Trajectories for healthy lifE in INdia (EINSTEIN) - a cluster randomized trial evaluating a multi-faceted intervention starting preconceptionally. A Healthy Life Trajectories Initiative (HeLTI) Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20161479
Enrollment
6000
Registered
2020-12-17
Start date
2021-03-15
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of non-communicable diseases in the next generation Other

Interventions

The study is a community-based, cluster-randomised intervention with three arms (preconception, pregnancy and control), with individual villages forming the basis for the cluster. Women in all three a

Sponsors

CSI Holdsworth Memorial Hospital
Lead Sponsor
Vivekananda Memorial Hospital
Collaborator
University of Toronto
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Women of childbearing age 2. Over the age of 18 years 3. Married 4. No children or one child 5. Planning to have a child within the next 2 years

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 18/12/2025: Those who are not planning pregnancy or have already completed their family or undergone sterilisation. Previous exclusion criteria: Those with two or more children

Design outcomes

Primary

MeasureTime frame
Adiposity measured by fat mass index (fat mass/height²) using dual x-ray absorptiometry (DXA) at age 5 years in the children across all HeLTI cohorts

Secondary

MeasureTime frame
Measured in the children at age 5 years: 1. Overweight and obesity (OWO) assessed by BMI and indicators of body composition and distribution (waist circumference, skinfold thickness) 2. Glucose metabolism measured by fasting venous plasma glucose concentration 3. Resting systolic blood pressure measured using an automated blood pressure monitor 4. Child development assessed using modified Kaufman battery, validated for Indian settings

Countries

India

Contacts

Public ContactKiran Nagaraj
eruhmh@gmail.com+91 (0)821 2521651

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026