CTRI Number	CTRI/2015/02/005517 [Registered on: 10/02/2015] Trial Registered Retrospectively
Last Modified On:	28/01/2015
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Behavioral
Study Design	Other
Public Title of Study Modification(s)	A behavior change communication study to improve nutrition status of pregnant women in Varanasi
Scientific Title of Study Modification(s)	Study of Effectiveness of TIPs (Trials of Improved Practices) methodology against Maternal Anemia in Chiraigaon Block of Varanasi District
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Siddharudha Shivalli  Address  Previous address:Department of Community Medicine, Institute of Medical Sciences, Banaras Hindu University Current address: Department of Community Medicine, Yenepoya Medical College Yenepoya University, Mangalore-575018, Karnataka, India Varanasi UTTAR PRADESH 221005 India  Phone  8431532566   Fax     Email  shivalli.bhu@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Ratan Kumar Srivastava  Address  Department of Community Medicine, Institute of Medical Sciences,Banaras Hindu University, India Department of Community Medicine, Institute of Medical Sciences,Banaras Hindu University, India Varanasi UTTAR PRADESH 221005 India  Phone  9415543467   Fax     Email  ratanpsm@gmail.com
Details Contact Person Public Query Modification(s)	Name  siddharudha shivalli  Address  Previous address: Department of Community Medicine, Institute of Medical Sciences, Banaras Hindu University Current address: Department of Community Medicine, Yenepoya Medical College Yenepoya University, Mangalore-575018, Karnataka, India Varanasi UTTAR PRADESH 221005 India  Phone  8431532566   Fax     Email  shivalli.bhu@gmail.com
Source of Monetary or Material Support	Institute of Medical Sciences, Banaras Hindu University
Primary Sponsor Modification(s)	Name  Department of Community Medicine  Address  Institute of Medical Sciences Varanasi-221005 Uttar Preadesh India  Type of Sponsor  Government 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  Siddharudha Shivalli  Varanasi, India  Charaigaon Community Development block Varanasi Varanasi   8431532566 shivalli.bhu@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Institue of Medical Scieences,Banaras Hindu University  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  pregnancy
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  pregnant women in 2 villages  Only baseline and end line data collection was done without any behaviour change communication intervention.   Intervention  Trial of Improved Practices method of behavior change communication tools  Trial of Improved Practices method of behavior change communication tool was employed through 3 home visits, over a period of 5 to 7 days,to study participants. The effect was assessed after 12 weeks from the third visit. Baseline and endline weight, hemoglobin%, anemia prevalence, dietary calorie, protein, calcium and iron intakes were compared.
Inclusion Criteria	Age From  18.00 Year(s) Age To  45.00 Year(s) Gender  Female  Details  Pregnant women in 13 to 28 weeks of gestation and willing to participate
ExclusionCriteria	Details  Pregnant women with severe acute illness severe medical or obstetrical complications, multiple pregnancy, gestational diabetes not staying for a minimum period of 12 weeks in the study area were excluded
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Gestational weight gain dietary intake of calorie protein hemoglobin level prevalence of anemia  12 weeks
Secondary Outcome	Outcome  TimePoints  NA  NA
Target Sample Size	Total Sample Size="100" Sample Size from India="100"
Phase of Trial	N/A
Date of First Enrollment (India)	04/01/2010
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="1" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	no
Brief Summary	A quasi experimental study was conducted on rural pregnant women of Varanasi, India. We hypothesied that trials of Improved practices (TIPs) is an effective behaviour change communication tool to improve the nutrition status of PW in the study area. Interpersonal communication, endorsing active participation of family members and home based reminder materials with encouraging messages and pictures for visual reinforcement are the TIPs based BCC strategies.