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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  
Grand Challenges Canada 
 
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  
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 
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  
Status 
Not Applicable 
 
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.

 
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