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Early Interventions to Support Trajectories for Healthy Life in India

Healthy Life Trajectories Initiative (HeLTI): Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN). - EINSTEIN

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030134
Enrollment
6000
Registered
2020-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

None listed

Interventions

Intervention1: Arm 1: Multi-faceted complex intervention starting pre-conceptionally and continuing through pregnancy and post-natally.: The multi-faceted interventions comprise: a) measures to optimi
b) a group parenting programme integrated with cognitive behavior therapy
c) a lifestyle behavior change intervention to support women to achieve a diverse diet, exclusive breastfeeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foo
and d) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance. Intervention2: Arm 2: Multi-faceted complex intervention starting in pregnancy and continuing thro
and d) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance. Control Intervention1: Arm 3: Enhanced standard of care.: This group will receive an enhanced stan

Sponsors

CSI Holdsworth Memorial Hospital
Lead Sponsor
Vivekananda Memorial Hospital
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Married women over the age of 18 years with no children or one child and intend to have a child within the next two years.

Exclusion criteria

Exclusion criteria: Women with two or more children.

Design outcomes

Primary

MeasureTime frame
The primary outcome at age 5 years in the children (across all HeLTI cohorts) is adiposity as measured by fat mass index (fat mass/height2), using DXA (dual x-ray absorptiometry).Timepoint: 5 years of age in the child.

Secondary

MeasureTime frame
Other key outcomes at 5 years in the children include: • Overweight and obesity (OWO) as assessed by BMI and indicators of body composition and distribution (waist circumference, skinfold thickness) • Glucose metabolism as measured by fasting venous plasma glucose concentration • Resting systolic blood pressure • Child development as assessed using modified Kaufman battery, validated for Indian settings. Timepoint: 5 years of age.

Countries

India

Contacts

Public ContactKiran KN

Epidemiology Research Unit, CSI Holdsworth Memorial Hospital, Mysore.

kumarank@hotmail.com08212521651

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 16, 2026