| 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
|
|
|
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
|
|
|
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. |