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CTRI Number  CTRI/2011/06/001822 [Registered on: 21/06/2011] Trial Registered Retrospectively
Last Modified On: 20/06/2011
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Breast Feeding Counselling 
Scientific Title of Study   “Effectiveness of cell phone counseling to improve breast feeding indicators.” 
Trial Acronym  BFC Study 
Secondary IDs if Any  
Secondary ID  Identifier 
LMRF/02  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Patel 
Designation  Vice President & CEO 
Affiliation  Professor & Head of Pediatrics Indira Gandhi Government Medical College Nagpur 
Address  Lata Medical Research Foundation Kinkine Kutir Opposite Hanuman Temple Vasant Nagar Colony Near Deeksha Bhoomi Square Nagpur 440022

Nagpur
MAHARASHTRA
440022
India 
Phone  7122249569  
Fax  7122249569  
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana Patel 
Designation  Vice President & CEO 
Affiliation  Professor & Head of Pediatrics Indira Gandhi Government Medical College Nagpur 
Address  Lata Medical Research Foundation Kinkine Kutir Opposite Hanuman Temple Vasant Nagar Colony Near Deeksha Bhoomi Square Nagpur 440022

Nagpur
MAHARASHTRA
440022
India 
Phone  7122249569  
Fax  7122249569  
Email  dr_apatel@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Patel 
Designation  Vice President & CEO 
Affiliation  Professor & Head of Pediatrics Indira Gandhi Government Medical College Nagpur 
Address  Lata Medical Research Foundation Kinkine Kutir Opposite Hanuman Temple Vasant Nagar Colony Near Deeksha Bhoomi Square Nagpur 440022

Nagpur
MAHARASHTRA
440022
India 
Phone  7122249569  
Fax  7122249569  
Email  dr_apatel@yahoo.com  
 
Source of Monetary or Material Support  
Alive AND Thrive Small Grants Program 
 
Primary Sponsor  
Name  Alive Thrive throgh Bill Melinda Gates Foundation 
Address  Department of Nutrition University of California Davis California 
Type of Sponsor  Other [University of California] 
 
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 
Dr Archana Patel  Lata Medical Research Founadation  Lata Medical Research Foundation Kinkine Kutir Opp Hanuman Temple Vasant Nagar Nr Deeksha Bhoomi Sq Nagpur 440022
Nagpur
MAHARASHTRA 
07122249569
07122249569
ceuiggmc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ICMR  Approved 
Lata Medical Research Foundation & Sir Gangadharrao Chitnavis Trust Ethics Review Committee (ERC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mothers registered at the antenatal clinic at 32- 36 weeks gestation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breast Feeding Counseling at hospital by health care staff  The existing staff of the hospitals will be provided training in Infant and Young Child Feeding(IYCF) by Breast Feeding Network of India(BPNI). They will be encouraged to set up their own systems to continue counseling during the ante natal period, at delivery and during the immunization visits. The participants will be asked to come for the same schedule of visits as in the intervention group where their data will be collected.  
Intervention  Breast Feeding counseling by cell phone   Intervention will be delivered to the women in the intervention cluster starting in pregnancy and until their child is 26 weeks to finally evaluate the Timely Initiation of Complementary Feeding (TICF)  
 
Inclusion Criteria  
Age From  8.00 Month(s)
Age To  9.00 Month(s)
Gender  Female 
Details  1. Women registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver and follow up in the same hospital and till 1 week after 6 months of infants age.

2.Absence of illness that will interfere with EBF like severe anemia (Hb 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated and HIV positivity

3. Those who consent

4. living in catchment area of 20 km from hospital.  
 
ExclusionCriteria 
Details  Those ANCs who do not satisfy inclusion criteria 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 24 weeks.   At Base line (32nd - 36th week) and follow-up visits as under
1. One week after enrollment
2. 24hours after delivery
3. 6th week after delivery
4. 10th week after delivery
5. 14th week after delivery
6. 24th week after delivery
7. 26th week after delivery


 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in % of a)women with TIBF b)women bottle feeding at all visits c) children introduced solid, semi-solid or soft foods at 24 wks measured at 26 wks
2.Differences in % of children receiving prelacteal feeds after delivery
3.Growth velocity
4.Change in hospitalization or mortality of the infant due to any cause, after delivery to 26 wks. 5.Cost data
6.Adherence to scheduled visits & infant immunization
7. Discontinued participant
 
At Base line (32nd - 36th week) and follow-up visits as under
1. One week after enrollment
2. 24hours after delivery
3. 6th week after delivery
4. 10th week after delivery
5. 14th week after delivery
6. 24th week after delivery
7. 26th week after delivery


 
 
Target Sample Size   Total Sample Size="1036"
Sample Size from India="1036" 
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   N/A 
Date of First Enrollment (India)   17/08/2010 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Project Title: Evaluation of the effectiveness of cell phone technology as community based intervention to improve exclusive breast feeding & reduce infant morbidity rates

 

Project Objective/s:

To demonstrate  the efficacy feasibility, acceptance and cost effectiveness of  cell phones for personalized lactation consultation and support  to improve infant feeding indicators (timely initiation of Breast feeding(TIBF) , exclusive breast feeding(EBF), timely initiation of complimentary feeding (TICF)), understand their barriers,  reduce infant morbidity and improve maternal satisfaction  in 2 urban maternity hospitals catering to socio-economically disadvantaged women. 

 

Project Strategy:

 

Pre-implementation (duration 6 months): Baseline TIBF, EBF rates, rates of cell phone use and reasons for failure of EBF are being collected in structured data collection instruments by the Lactational Counselors (LCs).

Inclusion Criteria:

Women registered at the antenatal clinic at 32-36 weeks gestation and planning to deliver and follow up in the same hospital and till 1 week after 6 months of infant`s age.

Absence of illness that will interfere with EBF like severe anemia (Hb < 6); eclampsia, pre-eclampsia, mother needing medicine for which breastfeeding is contraindicated and HIV positivity

Pilot/Baseline data - collected in three stages  

First stage (Jan 2010): -30 subjects x 4 time points = 120, pre BFHI training

Second stage (Apr 2010): -30 subjects x 7 time points = 210, pre BFHI training

Third stage (Jul 2010) :-20 subjects x 7 time points = 140, post BFHI training

 

Implementation phase (duration 9 months):

LCs at both hospitals are retrained for BFHI in partnership with the Breast Feeding Promotion Network of India (BPNI).   Beneficiaries from two hospitals (Intervention site) receive free cell phone in implementation phase with incoming call facility and provision to send free SMS.  The data is being collected by trained LCs using structured questionnaires at visits by mother to health facility. The mother has to  visit health facility 2 times in 3rd trimester, at the time of delivery and in the postnatal period at 6, 10, 14 weeks for scheduled immunization visits, 6th month and a week after the 6th month visit.     

The tools for clinical data collection are as under-

 Post Implementation (duration 3 months):  Sustainability of BF rates, minimal expected diet , rates of wasting and stunting in the intervention and control group is being  measured after active counselling has ceased at 6 months.

 

Constraints during Implementation Phase

 

Providing patient with special breast feeding ringtones and caller tunes is not  possible as it  requires a polyphonic (supporting MP3 player) handset with additional activation charges which is costlier and exceeds the budget.

Electronic digital instruments needed for physical assessments of the participant was not budgeted, so instruments available at the sites are being used

 

Key Outcomes:

 

Primary outcome

Secondary outcomes:

Exploratory outcomes:  


Recruitment Status : 276 mothers recruited under intervention arm and  368 mothers recruited under control arm. Total 644 mothers enrolled in the study out of the sample size of 1036.

 

A separate data entry software has been designed for entering the collected data with the matching interface with Case Report Forms.


 
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