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The effect of a comprehensive intervention package given before conception, during pregnancy, and in early childhood on the body fat and metabolic markers of pre-school children.

Long-term impact of an integrated intervention package delivered during preconception, pregnancy and early childhood on body fat and metabolic health in children aged 5-6 years - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/063819
Enrollment
640
Registered
2024-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil Control Intervention2: Nil: Nil

Sponsors

Dr Sunita Taneja
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participant in either the intervention or control group of the WINGS study. 2. Completed 5 years of age 3. Plan to stay within the study area for the next 1 month 4. No history of ongoing major illness or medical condition requiring prolonged treatment or hospitalization or frequent blood transfusions. 5. No record of any immunosuppressive condition (e.g., on steroids tuberculosis, Malignancies or any other immunosuppressive disease)

Exclusion criteria

Exclusion criteria: 1. Any ongoing fever or medical condition persisting for more thanlast 14 days or requires hospitalization. 2. Receiving concurrent treatment for an illness. 3. Any congenital or acquired disorder affecting growth. 4. Failure to obtain informed written consent from parents or guardians. 5. Any other condition that in the opinion of the study investigator serves as an exclusion. Note: Points 1 and 3 will be temporary exclusion criterion, children will be eligible for inclusion if they are not having any medical conditions, or any concurrent

Design outcomes

Primary

MeasureTime frame
Body fat mass Length for age Z score (LAZ)Timepoint: Once between 5 to 6 years of child age

Secondary

MeasureTime frame
Biomarkers related to growth (e.g. Insulin-like Growth Factor 1), metabolism (Serum Glutamic Pyruvic Transaminase, Thyroid Stimulating Hormone) and inflammation (C-Reactive Protein)Timepoint: Once between 5-6 years of child age;Fat-free mass, Fat Mass Index (FMI), Fat-Free Mass Index(FFMI)Timepoint: Once between 5-6 years of child age;Markers of metabolic health - Triglycerides, Total cholesterol, High-Density Lipoprotein, Low-Density Lipoprotein - Complete blood count - Adiponectin - Homeostasis model assessment insulin resistance (HOMA2-IR) - HOMA2-beta cell function - Carotid intima–media thickness - Resting systolic and diastolic blood pressure, mean arterial pressure - Weight-for-height Z (WHZ) score - Waist circumference - Body Mass IndexTimepoint: Once between 5-6 years of child age;Stunting (LAZ = 2SD)Timepoint: Once between 5-6 years of child age

Countries

India

Contacts

Public ContactDr Bireshwar Sinha

Society for Applied Studies, Centre for Health Research and Development

bireshwar.sinha@sas.org.in01146043751

Outcome results

None listed

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