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CTRI Number  CTRI/2025/03/083577 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   To study Learn Eat and Develop Intervention for improving child development 
Scientific Title of Study   Evaluation Of LEAD (Learn, Eat And Develop) Intervention for Mothers to Improve Early Childhood Development and Reduce Stunting in Infants of Urban Slums of Nagpur, Wardha and Belagavi districts in India. 
Trial Acronym  LEAD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Research Department, Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S

Nagpur
MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Research Department, Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S


MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Patel 
Designation  Program Director 
Affiliation  Lata Medical Research Foundation 
Address  Research Department, Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S


MAHARASHTRA
440022
India 
Phone  07122249569  
Fax    
Email  dr_apatel@yahoo.com  
 
Source of Monetary or Material Support  
DBT/Wellcome Trust India Alliance, Nishant House, 8-2-351/N/1, 2nd floor, Road No. 2, Venkateshwara Hills, Banjara Hills, Hyderabad - 500034  
 
Primary Sponsor  
Name  DBT/Wellcome Trust India Alliance 
Address  8-2-351/N.1, Nishant House, 2nd Floor Rd. No. 2, Banjara Hills, Hyderabad, TS500034 
Type of Sponsor  Other [Charitable Foundation] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Zahiruddin Syed Qazi  Datta Meghe Institute of Higher Education and Research   JNMC department of R&D and Community Medicine, DMIHER, Sawangi, Wardha
Wardha
MAHARASHTRA 		 9765404065

zahirquazi@gmail.com 
Dr N S Mahantshetti   KLE Academy of Higher Education and Research   Department of Pediatrics, JN Medical College Campus, Belgavi
Belgaum
KARNATAKA 		 9448157237

niranjanasn@yahoo.com 
Dr Archana Patel  Lata Medical Research Foundation  Research Department 9/1, Kinkini Kutir, Vasant Nagar, Nagpur 22
Nagpur
MAHARASHTRA 		 07122249569

dr_apatel@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF DMIHER  Approved 
Institutional Ethics Committee of KLE Academy of Higher Education and REsearch   Approved 
Lata Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O369||Maternal care for fetal problem, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  Existing standard of care and routine health care services provided at the UPHCs and AWCs by the government. 
Intervention  LEAD intervention package   LEAD intervention package delivered to pregnant women (£ 20 weeks of gestation) through delivery till their infants are 12 months of age consisting of: (i) In-person counselling using android App embedded health awareness counselling messages and videos by Anganwadi Workers - Monthly home visits from enrolment through delivery till their infants are 12 months of age (ii) Telephonic counselling provided by ANM to mothers using mobile phones– Fortnightly basis from enrolment through delivery till their infants are 12 months of age (iii) In-person visits for Early Childhood Education and Care (ECEC) parenting curriculum by community peer mentors (BalSakhi) - Fortnightly home visits from enrolment through delivery till their infants are 12 months of age and Group meetings on monthly basis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  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 
 
ExclusionCriteria 
Details  i) HIV positive cases
ii) Those who do not consent 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Early Childhood Development using ASQ and BSID
scores and Stunting 		 End point 
 
Secondary Outcome  
Outcome  TimePoints 
Antenatal and postnatal visits events (healthcare seeking behaviour, good ANC
practices, medication (Fe, Ca)& Immunization compliance etc) 		 At enrolment, 2nd,
3rd Trimesters, Delivery; monthly for12 months, then at 15 and 18 months 
Maternal nutrient  2nd & 3rd Trimester of pregnancy 
Fetal loss  at end of pregnancy 
Preterm birth, Low Birth Weight, Newborn complications  At delivery 
Infant outcomes (Mortality, Morbidity, Hospitalization, Immunization status),  at 12 months of age 
reastfeeding (Timely Initiation and Exclusive Breastfeeding),  at birth, 3 months, 6 months 12 months, 15 months & 18 months of age 
Nutrition, semi-solid or soft foods/ Nutrient adequacy,  at birth, 3 months, 6 months 12
months, 15 months & 18 months of age 
Wasting,  at 18 months of age 
Knowledge and performance of AWW and BalSakhis,  At baseline and Endline 
Fidelity, dose(completeness of exposure) reach, satisfaction and contextual
assessment, 		 6 monthly 
 
Target Sample Size   Total Sample Size="1636"
Sample Size from India="1636" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  On signing Non disclosure agreement

  6. For how long will this data be available start date provided 01-03-2029 and end date provided 28-02-2034?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.
 
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