CTRI Number	CTRI/2017/05/008553 [Registered on: 15/05/2017] Trial Registered Prospectively
Last Modified On:	15/11/2019
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Behavioral
Study Design	Cluster Randomized Trial
Public Title of Study	To study the effects of maternal nutrition and parenting program on cognitive development of children from rural India at 2 years of age.
Scientific Title of Study Modification(s)	Effectiveness of maternal nutrition and parenting program on cognitive development of children from rural India at 2 years of age: A Cluster RCT.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Quazi Syed Zahiruddin  Address  Professor, Dept. of Community Medicine, 2nd Floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha Doctors Enclave, Dreamland City, Sawangi (M, Wardha Wardha MAHARASHTRA 442001 India  Phone  9765404065   Fax     Email  zahirquazi@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Quazi Syed Zahiruddin  Address  Professor, Dept. of community Medicine, 2nd floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha Doctors Enclave, Dreamland City, Sawangi (M, Wardha Wardha MAHARASHTRA 442001 India  Phone  9765404065   Fax     Email  zahirquazi@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Abhay Gaidhane  Address  Head, Dept. of Community Medicine, 2nd Floor, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha Doctors Quarter-12, AVBRH Campus, Sawangi (M), Wardha Wardha MAHARASHTRA 442001 India  Phone  9765404075   Fax     Email  abhaygaidhane@gmail.com
Source of Monetary or Material Support Modification(s)	Grand Challenges, Canada, MaRS Centre, West Tower 661 University Avenue, Suite 1720 Toronto, Canada ON M5G 1M1
Primary Sponsor Modification(s)	Name  Datta Meghe Institute of Medical Sciences  Address  Jawaharlal Nehru Medical College Campus,Yawatmal Road, Sawangi (M), Wardha-442001  Type of Sponsor  Private medical college
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Quazi Syed Zahiruddin  Acharya Vinoba Bhave Rural Hospital, Sawangi (M),Wardha  Dept. of Community Medicine, 2nd Floor, JNMC Building, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha Wardha   9765404065 zahirquazi@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences (DU), Wardha  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Pregnant Women and Mother-Child dyads
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Pregnant Woman and mother-child dyads  The participants in control arm will receive only Routine Care of ICDS and Health Department.  Intervention  Pregnant women and mother-child dyads  The participants in intervention arm will receive intervention on Nutrition during pregnancy and also intervention on Positive Parenting along with Routine Care from ICDS and Health Department.
Inclusion Criteria Modification(s)	Age From  19.00 Year(s) Age To  45.00 Year(s) Gender  Female  Details  1. Pregnant Women and woman-child dyads
ExclusionCriteria	Details  1. Women refusing to participate in study. 2. Women with High Risk Pregnancies.
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Improvement in gross and fine motor development, cognitive, language and socio-emotional development of children at 1 year of age.   At 1 years of child age.
Secondary Outcome	Outcome  TimePoints  Improvement in parenting skills and knowledge of caregivers. Improvement in Home Environment of children at 2 years of age. Improvement in Parent Child interactions in intervention arm. Improvement in anthropometric measurements of children.  At 1 year of child age.
Target Sample Size	Total Sample Size="360" Sample Size from India="360"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	15/05/2017
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	None Yet
Brief Summary	This programme aims to study the impact on Child development parameters at 2 years of age through integrated intervention that will blend the nutrition intervention with parenting program and developing and promoting a social business plan. We will develop 1) ‘A Food Basket’ for pregnant women to ensure nutritional needs during pregnancy and 2) a parenting program aimed at enhancing knowledge and skills of caregiver for positive parenting. Intervention will be managed in close collaboration, support from the departments of public health and women and child development in Government. We intend to promote and support the Local Women Groups (LWGs) for creating a social franchise model in which women will be trained to develop Food Basket that will be purchased by pregnant women through voucher scheme of project. This social business model will be self sustainable and will help to enhance the motor, language and socio-emotional development of children in first 1000 days of life. Children will be assessed for physical, cognitive, motor, language and socio-emotional development at 12 months, 18 months and  24 months of age.