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Effect of an integrated package of nutrition, health, responsive care, and early child stimulation interventions from 2 to 5 years of age on linear growth, cognitive development, and metabolic health in preterm or small-for-gestational-age children, compared with routine care, in Delhi, India

Impact of Integrated Interventions in the Next 1000 days to Promote Optimum Growth, Neurodevelopment and Metabolic Health in Small and Vulnerable Children (SAMPOORNA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093339
Enrollment
1600
Registered
2025-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Nutrition: - Counselling on optimal diet Dietary diversity, portion size, responsive feeding
based on ICMR 2024, WHO guidelines. - Micronutrient supplementation Iron?Folic Acid (IFA): Weekly dosing for 2?5 years Vitamin A: Every 6 months after
replenished every 2 weeks: 24 to 30 mo: Premix Supplementation (wheat, pulses, groundnuts) From 30 months onwards, In house prepared snack options biscuits, crunchy bites etc. Intervention3: Nutritio
WHO guidelines. Anemia screening and management- Annually and referral
based on Anemia Mukt Bharat (2.0). Immunization and deworming as per National Immunization Schedule
deworming every 6 months per GOI guidelines. Dental caries screening every 6 months. Vision and hearing screening at 24 months
referral if indicated. Intervention5: Responsive caregiving and early stimulation counselling: Positive parenting, play-based learning, screen time reduction
WHO, AAP. Frequency

Sponsors

Sunita Taneja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participant in either intervention or control group of the Small Babies Trial Child aged 24 months (?29 days) at enrollment Family intends to remain in study area for next 3 years Written informed consent from parent/caregiver

Exclusion criteria

Exclusion criteria: Any chronic diagnosed condition which impairs growth Diagnosed and documented neurodevelopmental impairment currently receiving specialized therapy

Design outcomes

Primary

MeasureTime frame
Linear Growth: Height-for-age z-score (HAZ) Neurodevelopment: IQ, Executive function, School readiness assessed using standardized toolsTimepoint: 5 years 5 years

Secondary

MeasureTime frame
Metabolic Health: Biomarkers (HOMA-IR, lipid profile, HbA1c, CRP, IL-6, adiponectin, leptin. HaemoglobinTimepoint: 5 years;Anthropometry (Wt, ht; head, waist ? circumference, MUAC)Timepoint: Every 6 months starting from 2 years;Morbidity & care-seekingTimepoint: Every 6 months starting from 2 years;Dietary intake/diversity (subsample)Timepoint: Baseline, 3, 4 & 5 years;Parental EmpowermentTimepoint: Baseline and 5 years;Body Composition (DXA)Timepoint: 5 years;Non-alcoholic fatty liver disease: Abdominal ultrasoundTimepoint: 5 years;Physical activityTimepoint: Baseline, 5 years

Countries

India

Contacts

Public ContactRavi Prakash Upadhyay

Society for Applied Studies

ranadip.chowdhury@sas.org.in7838870359

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026