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

NCT ID: NCT00983489

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-08-31

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.

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.

Conditions

Exclusive Breast Feeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

counselling

counselling: Breast feeding counselling will be done to mothers

Group Type: ACTIVE_COMPARATOR

counselling

Intervention Type: BEHAVIORAL

breast feeding counselling

Video demonstration

Video demonstration to mothers on the advantages of exclusive breast feeding

Group Type: ACTIVE_COMPARATOR

video demonstration

Intervention Type: BEHAVIORAL

video will be shown to mothers

Standard Care

Standard care includes the routine care provided to the neonates as per hospital protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

video demonstration

video will be shown to mothers

Intervention Type: BEHAVIORAL

counselling

breast feeding counselling

Intervention Type: BEHAVIORAL

Eligibility 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.

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deen Dayal Upadhyay Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Kanchan Sharma

DNB resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ddu001

Identifier Type: -

Identifier Source: org_study_id