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

April 5, 2013 updated by: Dr Kanchan Sharma, Deen Dayal Upadhyay Hospital

Comparison of Impact of Breast Feeding Counseling of Mothers and Use of Audio-video Aids on Breast Feeding Rates at Six Weeks Postnatal Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1411

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deen Dayal Upadhyay Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ddu001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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