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CTRI Number  CTRI/2024/01/061979 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 30/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Other 
Public Title of Study   Creches for early childhood development in Odisha, India  
Scientific Title of Study   Implementation science for early childhood development in Odisha, India  
Trial Acronym  ISEC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shibanand Rath  
Designation  Principal Investigator - Programme Manager  
Affiliation  Ekjut 
Address  556B Potka Chakradharpur West Singhbhum

Pashchimi Singhbhum
JHARKHAND
833102
India 
Phone  9437229651  
Fax    
Email  Shibanand.ekjut@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shibanand Rath  
Designation  Principal Investigator - Programme Manager  
Affiliation  Ekjut 
Address  556B Potka Chakradharpur West Singhbhum


JHARKHAND
833102
India 
Phone  9437229651  
Fax    
Email  Shibanand.ekjut@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shibanand Rath  
Designation  Principal Investigator - Programme Manager  
Affiliation  Ekjut 
Address  556B Potka Chakradharpur West Singhbhum


JHARKHAND
833102
India 
Phone  9437229651  
Fax    
Email  Shibanand.ekjut@gmail.com  
 
Source of Monetary or Material Support  
UK Economic Social and Research Council  
 
Primary Sponsor  
Name  University College London  
Address  Gower St, Kings Cross, London WC1E 6BS, United Kingdom  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shibanand Rath  Ekjut   556B Potka Chakradharpur NB: This trial is community-based, not hospital-based. The trial will take place in rural Keonjhar, Odisha. The lead organisation, Ekjut, is based near Keonjhar, in West Singhbhum, Jharkhand, and runs creches in Keonjhar district. We have a letter of support from the Office of the Collector and District Magistrate, Keonjhar, for the study.
Kendujhar
ORISSA 
9437229651

Shibanand.ekjut@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of the National Institute of Science Education and Research, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Undernutrition Poor development  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Creches  The intervention is exposure to creches for early childhood development in rural Keonjhar, Odisha. Creches have clean water, serve two hot cooked meals per day, provide stimulating activities for children, and also serve as hubs for parents’ meetings where creche workers discuss good health, nutrition, protection, and stimulation practices for parents of children attending the creches and others in the community. 350 children aged 6-24 months attending 30 purposively selected creches run by the Indian civil society organisation Ekjut in Keonjhar District, along with their caregivers, will be selected as intervention participants.  
Comparator Agent  Usual care  Another 350 children aged 6-24 months and their caregivers will identified through a household survey in nearby comparable villages in Keonjhar, Odisha, and be approached to act as control participants. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  80.00 Year(s)
Gender  Both 
Details  700 children aged 6-24 months at the time of the study enrolment survey and in comparable villages, as well as their primary caregivers, to be followed-up and re-interviewed 12 months after enrolment. 
 
ExclusionCriteria 
Details  Children with severe congenital anomalies, including severe neural tube defects and Down’s Syndrome 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Global Scale of Early Development (GSED) score  Measured first when children are aged 6-24 months and then when they are 18-36 months 
 
Secondary Outcome  
Outcome  TimePoints 
Parental stress  12 months after recruitment 
Mean weight for age z scores for children  12 months after recruitment 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
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   Phase 3 
Date of First Enrollment (India)   01/02/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

In this study, we propose to research the effects of free creches (daycare centres) months on the development and nutrition of children aged 6 to 36 months living in the rural district of Keonjhar in Odisha, Eastern India. Ekjut manages over 50 creches for children aged 6 to 36 months in Keonjhar. The creches have clean water, are smoke-free, serve two hot cooked meals per day, provide stimulating activities for children, and also serve as hubs for parents’ meetings where creche workers discuss good health, nutrition, protection, and stimulation practices for parents of children attending the creches and others in the community.

 

We will select 30 of these creches and follow up 350 children aged 6-24 months enrolled in them for 12 months, along with a group of children the same age in nearby, comparable villages. We will conduct a questionnaire interview with parents of children in both groups (those in creches and those not in creches) to capture information on families’ socio-economic characteristics, access to health and nutrition services, and how stressed parents feel in meeting their caregiving obligations. We will also children’s development and nutritional status 12 months after recruitment to understand whether creches benefit children. 

 

 
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