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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The investigators hypothesize that counseling of mothers will increase exclusive breast feeding rates at six weeks postnatal age. In developing countries like India,there is shortage of staff and the number of newborns cared is huge. So counseling of mothers for breast feeding becomes difficult. In such a situation using audio-visual aids may be a more practical option to increase breast feeding rates. Therefore the investigators will compare the use of video demonstration with counseling for exclusive breast feeding.

Condition or disease	Intervention/treatment	Phase
Exclusive Breast Feeding	Behavioral: video demonstration; Behavioral: counselling	Not Applicable

Detailed Description:

1. Study design - Randomized controlled trial.
2. Inclusion criteria- All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.

3. Exclusion criteria -

   1. Sick mother who is unable to communicate
   2. Congenital malformation
   3. Babies admitted in neonatal intensive care unit
   4. HIV positive mother
   5. Mother on chemotherapy/planned for chemotherapy.
4. Setting of the study - The study will be conducted at postnatal wards of DDUH, New Delhi
5. Period of study-January 2009 to December 2009.
6. Sample size- We did a pilot study to see the baseline exclusive breast feeding rates at six weeks in mothers who delivered at DDUH. The baseline exclusive breast feeding rates at six weeks is 60%. Expecting a 10% absolute increase in exclusive breast feeding rates and alpha=0.05 and power beta=80% our sample size is 376 per group. Taking into account the loss to follow up of 20% we plan to enroll 470 mothers per group. So our sample size is 1410 mothers.
7. Ethics and consent-Ethical clearance will be obtained from ethical committee of DDUH. Written and informed consent will be taken from the mothers before enrolment.
8. Randomization - It will be an open-label randomized controlled trial. Random numbers will be obtained from a computer generated table. Mothers will be grouped into three groups: counseling group, video group and control group. The codes will be kept in sealed opaque envelopes. There will be allocation concealment since the mothers and the principle investigator will be unaware of the group to which they will be randomized.
9. Methods- The principle investigator will visit the postnatal wards daily except on holidays and look for the eligible mothers who will be asked for written and informed consent. Those who give the consent will be enrolled and randomized to counseling group, video group and control groups. The mothers in the intervention group will be counseled along with the husband and mother/mother-in-law/female caretaker. The mothers in the video group will be shown a video on breast feeding. The baseline characteristics of the three groups will be recorded. The mothers in the control group will receive standard care.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1411 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Comparison of Impact of Breast Feeding Counseling of Mothers and Use of Audio-video Aids on Breast Feeding Rates at Six Weeks Postnatal Age
Study Start Date :	September 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	August 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: counselling; counselling: Breast feeding counselling will be done to mothers	Behavioral: counselling; breast feeding counselling
Active Comparator: Video demonstration; Video demonstration to mothers on the advantages of exclusive breast feeding	Behavioral: video demonstration; video will be shown to mothers
No Intervention: Standard Care; Standard care includes the routine care provided to the neonates as per hospital protocol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Exclusive Breast Feeding Rate at Six Weeks Postnatal Age [ Time Frame: 6 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 24 Hours (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• All mothers who deliver at term at Deen Dayal Upadhayay Hospital [DDUH ]whether booked or unbooked.

Exclusion Criteria:

• Sick mother who is unable to communicate
• Congenital malformation
• HIV positive mother
• Mother on chemotherapy/planned for chemotherapy.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Kanchan Sharma, DNB resident, Deen Dayal Upadhyay Hospital
ClinicalTrials.gov Identifier:	NCT00983489 History of Changes
Other Study ID Numbers:	ddu001
First Posted:	September 24, 2009
Results First Posted:	May 24, 2013
Last Update Posted:	May 24, 2013
Last Verified:	April 2013

Keywords provided by Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital:

breast feeding; counselling; video demonstration