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CompletedNCT00983489Updated May 24, 2013Results posted

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

An interventional study of video demonstration and counselling in Exclusive Breast Feeding, sponsored by Deen Dayal Upadhyay Hospital. Completed. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Deen Dayal Upadhyay Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
1,411
Allocation
Randomized
Ages
Up to 24 Hours
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Exclusive Breast Feeding

Keywords

  • breast feeding
  • counselling
  • video demonstration
03

In context

Lead sponsor

This is the only study on the registry with Deen Dayal Upadhyay Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Sick mother who is unable to communicate
  • Congenital malformation
  • HIV positive mother
  • Mother on chemotherapy/planned for chemotherapy.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,411 participants (actual)

Study arms

  • Active comparator
    counselling

    counselling: Breast feeding counselling will be done to mothers

    Behavioral: counselling

  • Active comparator
    Video demonstration

    Video demonstration to mothers on the advantages of exclusive breast feeding

    Behavioral: video demonstration

  • No intervention
    Standard Care

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

Interventions

  • Behavioralvideo demonstration

    video will be shown to mothers

  • Behavioralcounselling

    breast feeding counselling

06

What researchers measure

Primary outcomes

  1. Exclusive Breast Feeding Rate at Six Weeks Postnatal Age

    Time frame: 6 weeks

07

Results

Posted May 24, 2013

Participant flow

January 2009 to June 2010 Tertiary care neonatal unit

Participant flow — Overall Study
MilestoneCounsellingVideo DemonstrationStandard Care
Started511453447
Completed326168135
Not completed185285312

Outcome measures

PrimaryExclusive Breast Feeding Rate at Six Weeks Postnatal Age
Time frame:
6 weeks
Reported as:
Number · Participants
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age
ParticipantsCounsellingVideo DemonstrationStandard Care
Exclusive Breast Feeding Rate at Six Weeks Postnatal Age27111797

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Counselling———
Video Demonstration———
Standard Care———

Baseline characteristics

Age Continuous
Age Continuous(years)CounsellingVideo DemonstrationStandard CareTotal
Mean23.7 ± 3.223.9 ± 3.824.3 ± 3.624.0 ± 3.5
Sex: Female, Male
Sex: Female, Male(Participants)CounsellingVideo DemonstrationStandard CareTotal
Female243215219677
Male268238228734
Region of Enrollment
Region of Enrollment(participants)CounsellingVideo DemonstrationStandard CareTotal
India5114534471411
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00983489
Lead sponsor
Deen Dayal Upadhyay Hospital
Responsible party
Dr Kanchan Sharma (DNB resident, Deen Dayal Upadhyay Hospital) — Principal investigator
First posted
Sep 24, 2009
Start date
Sep 2009
Primary completion
Aug 2010
Completion
Aug 2010
Results posted
May 24, 2013
Last update
May 24, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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