CTRI Number |
CTRI/2018/03/012840 [Registered on: 26/03/2018] Trial Registered Retrospectively |
Last Modified On: |
03/12/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Improved Child Nutrition and Intellectual Development through Technology, home visits and Father Involvement in India |
Scientific Title of Study
|
Improved Child Nutrition and Intellectual Development through Technology, home visits and Father Involvement in India |
Trial Acronym |
SB_IFMR |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sapna Nair |
Designation |
Research Fellow |
Affiliation |
Institute of Financial Management and Research |
Address |
#4, IFMR LEAD, Buhari Towers, Moores Road,
Nungambakkam Chennai 24, Kothari Road, Nungambakkam, Chennai Chennai TAMIL NADU 600006 India |
Phone |
9945774546 |
Fax |
|
Email |
sapna.nair@ifmr.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Sitanshu Kar |
Designation |
Additional Professor |
Affiliation |
JIPMER |
Address |
Dr. Sitanshu Sekhar Kar
Additional Professor of Preventive & Social Medicine, Associate Dean,
JIPMER, Puducherry 605006.
Pondicherry PONDICHERRY 605006 India |
Phone |
9487896550 |
Fax |
|
Email |
drsitanshukar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sapna Nair |
Designation |
Research Fellow |
Affiliation |
Institute of Financial Management and Research |
Address |
#4, IFMR LEAD, Buhari Towers, Moores Road,
Nungambakkam Chennai 24, Kothari Road, Nungambakkam, Chennai
TAMIL NADU 600006 India |
Phone |
9945774546 |
Fax |
|
Email |
sapna.nair@ifmr.ac.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Grand Challenges Canada |
Address |
MaRS Centre, West Tower
661 University Avenue, Suite 1720
Toronto, ON M5G 1M1 |
Type of Sponsor |
Other [International Funding Agency] |
|
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 |
Sapna Nair |
India |
#4, Buhari Towers, Moores Road, Nungambakkam, Chennai Madurai TAMIL NADU |
9945774546
sapna.nair@ifmr.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IFMR Human Subjects Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Young children between 0-3 years |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control |
Regular ICDS child development outreach activities |
Intervention |
Intervention arm |
1. Anganwadi workers use Tablets to give cognitive and nutrition development to parents during home visits. Messaging on phones will reinforce messaging. 2.Fathers meeting for encouraging paternal involvement in child care. 3. Use of mobile top-ups to encourage the participation of the fathers in the child development activities. |
|
Inclusion Criteria
|
Age From |
1.00 Month(s) |
Age To |
3.00 Year(s) |
Gender |
Both |
Details |
All children in selected age group in selected Anganwadis |
|
ExclusionCriteria |
Details |
Not in age group, parents unwilling to participate |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Improved child development, improved access to child development messages, Improved involvement in child care |
At the end of one year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improved knowledge on child care practices among parents |
1 year |
|
Target Sample Size
|
Total Sample Size="1400" Sample Size from India="1400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1370" |
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
19/03/2018 |
Date of Study Completion (India) |
30/06/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Early childhood is a period of extreme importance in a child’s developmental journey. Research evidence worldwide points out to the importance of early stimulation in the first three years of child’s life since this is the age when maximum brain development happens in a human. Deprivation of appropriate stimulation at this time has a lasting impact on a child’s physical, cognitive and emotional health. However, opportunities for cognitive development are unavailable to most children in India. Government programmes for children, especially in the 0-3 years age group, favour cure and prevention over promotive care and are not directed towards improving cognitive development. Their focus lies in preventing children in this age group from falling off the expected basic standards on physical development charts and on supplementation if found severely undernourished. Paternal involvement has also been found to have a positive psychological and social impact on a child that in turn has an impact on cognitive development of young children. Government programmes currently hinge entirely on the mother as the primary recipient of information and action and do not disseminate any information on the role of a father in child development. This study seeks to promote positive development of intellect and nutrition of children under three years of age by disseminating information and integrating gender approaches into the existing mother and child health framework. It will be built into the ongoing Integrated Child Development Services programme (ICDS) managed by the Department of Social Welfare. There are two major components to the intervention strategy. One, using information technology to disseminate information to parents through the network of Anganwadi workers. This will happen through door to door outreach as well as messages sent over phones giving out targeted information on early stimulation, parenting, and involvement of fathers in child care as well as nutritional information to parents. Two, increasing the involvement of the fathers in child care by conducting regular fathers group meetings which involve selected father role models, sending norm challenging messages and giving out incentives in the form of mobile phone credit. The study will be implemented within a Randomised Control Trial with a nested qualitative longitudinal case study in order to gain an in-depth understanding of the impact of the intervention and the path to change. The overall goal is be to integrate the learnings to scale up at the state level and promote policy advocacy at the Central Government level. The widespread presence of Anganwadis as a part of The Integrated Child Development Services (ICDS) all over India makes a large scale implementation of these interventions highly possible. |