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

Exclusive Breast Feeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983489
• Other study ID #: ddu001
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: April 5, 2013
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2013
• Source: Deen Dayal Upadhyay Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1411
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Exclusive Breast Feeding

Intervention

Behavioral:
• video demonstration
video will be shown to mothers
• counselling
breast feeding counselling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deen Dayal Upadhyay Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive Breast Feeding Rate at Six Weeks Postnatal Age		6 weeks	No