To study Learn Eat and Develop Intervention for improving child development

Not yet recruiting

Conditions: Maternal care for fetal problem, unspecified,

Registration Number: CTRI/2025/03/083577

Lead Sponsor: DBT/Wellcome Trust India Alliance

Brief Summary: This is a community-based, cluster randomized trial for evaluation of effectiveness of the “The

Learn, Eat, And Develop” or LEAD intervention in 1,636 mother baby dyads in 60 cluster from

urban slums within Nagpur, Wardha and Belagavi cities of India. The primary outcome measures

are early childhood development and stunting at 18 months. Secondary outcomes include

measures related to antenatal/postnatal care, maternal nutrition, hygiene, fetal/baby indicators,

AWW/BalSakhi indicators, and process indicators at various timepoints.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 1636

Inclusion Criteria

i) Pregnant women more than 18 years of age, pregnancy confirmed by UPT and/or USG ii) Gestational age within 20 weeks confirmed by LMP and/or USG, iii) Planning to reside in the same cluster through delivery till their infant is 18 months of age iv) Willing to participate and provide informed consent.

Exclusion Criteria

i) HIV positive cases ii) Those who do not consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Early Childhood Development using ASQ and BSID	End point
scores and Stunting	End point

Secondary Outcome Measures

Name	Time	Method
reastfeeding (Timely Initiation and Exclusive Breastfeeding),	at birth, 3 months, 6 months 12 months, 15 months & 18 months of age
Knowledge and performance of AWW and BalSakhis,	At baseline and Endline
Antenatal and postnatal visits events (healthcare seeking behaviour, good ANC	practices, medication (Fe, Ca)& Immunization compliance etc)
Infant outcomes (Mortality, Morbidity, Hospitalization, Immunization status),	at 12 months of age
Nutrition, semi-solid or soft foods/ Nutrient adequacy,	at birth, 3 months, 6 months 12
Wasting,	at 18 months of age
Fetal loss	at end of pregnancy
Preterm birth, Low Birth Weight, Newborn complications	At delivery
Maternal nutrient	2nd & 3rd Trimester of pregnancy
Fidelity, dose(completeness of exposure) reach, satisfaction and contextual	assessment,

Trial Locations

Locations (3): Datta Meghe Institute of Higher Education and Research
🇮🇳
Wardha, MAHARASHTRA, India
KLE Academy of Higher Education and Research
🇮🇳
Belgaum, KARNATAKA, India
Lata Medical Research Foundation
🇮🇳
Nagpur, MAHARASHTRA, India
Datta Meghe Institute of Higher Education and Research
🇮🇳Wardha, MAHARASHTRA, India
Dr Zahiruddin Syed Qazi
Principal investigator
9765404065
zahirquazi@gmail.com