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Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks

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ClinicalTrials.gov Identifier: NCT00983489
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : May 24, 2013
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Exclusive Breast Feeding
Interventions Behavioral: video demonstration
Behavioral: counselling
Enrollment 1411
Recruitment Details January 2009 to June 2010 Tertiary care neonatal unit
Pre-assignment Details None excluded after enrolment. Those who did not follow up were not analysed.
Arm/Group Title Counselling Video Demonstration Standard Care
Hide Arm/Group Description counselling: Breast feeding counselling will be done to mothers Video demonstration to mothers on the advantages of exclusive breast feeding Standard care includes the routine care provided to the neonates as per hospital protocol
Period Title: Overall Study
Started 511 453 447
Completed 326 168 135
Not Completed 185 285 312
Arm/Group Title Counselling Video Demonstration Standard Care Total
Hide Arm/Group Description counselling: Breast feeding counselling will be done to mothers Video demonstration to mothers on the advantages of exclusive breast feeding Standard care includes the routine care provided to the neonates as per hospital protocol Total of all reporting groups
Overall Number of Baseline Participants 511 453 447 1411
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 511 participants 453 participants 447 participants 1411 participants
23.7  (3.2) 23.9  (3.8) 24.3  (3.6) 24.0  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 511 participants 453 participants 447 participants 1411 participants
Female
243
  47.6%
215
  47.5%
219
  49.0%
677
  48.0%
Male
268
  52.4%
238
  52.5%
228
  51.0%
734
  52.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 511 participants 453 participants 447 participants 1411 participants
511 453 447 1411
1.Primary Outcome
Title Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
Hide Description [Not Specified]
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Counselling Video Demonstration Standard Care
Hide Arm/Group Description:
counselling: Breast feeding counselling will be done to mothers
Video demonstration to mothers on the advantages of exclusive breast feeding
Standard care includes the routine care provided to the neonates as per hospital protocol
Overall Number of Participants Analyzed 326 168 135
Measure Type: Number
Unit of Measure: Participants
271 117 97
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Counselling Video Demonstration Standard Care
Hide Arm/Group Description counselling: Breast feeding counselling will be done to mothers Video demonstration to mothers on the advantages of exclusive breast feeding Standard care includes the routine care provided to the neonates as per hospital protocol
All-Cause Mortality
Counselling Video Demonstration Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Counselling Video Demonstration Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Counselling Video Demonstration Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Kanchan Sharma
Organization: Deen Dayal Upadhaya Hospital, New Delhi
Phone: 919417938224
Responsible Party: Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital
ClinicalTrials.gov Identifier: NCT00983489     History of Changes
Other Study ID Numbers: ddu001
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: April 5, 2013
Results First Posted: May 24, 2013
Last Update Posted: May 24, 2013