Exclusive Breast Feeding
Conditions
Keywords
breast feeding, counselling, video demonstration
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.
Interventions
BEHAVIORALvideo demonstration
video will be shown to mothers
BEHAVIORALcounselling
breast feeding counselling
Sponsors
Deen Dayal Upadhyay Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exclusive Breast Feeding Rate at Six Weeks Postnatal Age | 6 weeks |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Counselling counselling: Breast feeding counselling will be done to mothers | 511 |
| Video Demonstration Video demonstration to mothers on the advantages of exclusive breast feeding | 453 |
| Standard Care Standard care includes the routine care provided to the neonates as per hospital protocol | 447 |
| Total | 1,411 |
Baseline characteristics
| Characteristic | Total | Video Demonstration | Standard Care | Counselling |
|---|---|---|---|---|
| Age Continuous | 24.0 years STANDARD_DEVIATION 3.5 | 23.9 years STANDARD_DEVIATION 3.8 | 24.3 years STANDARD_DEVIATION 3.6 | 23.7 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment India | 1411 participants | 453 participants | 447 participants | 511 participants |
| Sex: Female, Male Female | 677 Participants | 215 Participants | 219 Participants | 243 Participants |
| Sex: Female, Male Male | 734 Participants | 238 Participants | 228 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counselling | Exclusive Breast Feeding Rate at Six Weeks Postnatal Age | 271 Participants |
| Video Demonstration | Exclusive Breast Feeding Rate at Six Weeks Postnatal Age | 117 Participants |
| Standard Care | Exclusive Breast Feeding Rate at Six Weeks Postnatal Age | 97 Participants |