NCT00983489

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 24, 2013

Completed
Last Updated

May 24, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

September 22, 2009

Results QC Date

April 5, 2013

Last Update Submit

April 5, 2013

Conditions

Keywords

breast feedingcounsellingvideo demonstration

Outcome Measures

Primary Outcomes (1)

  • Exclusive Breast Feeding Rate at Six Weeks Postnatal Age

    6 weeks

Study Arms (3)

counselling

ACTIVE COMPARATOR

counselling: Breast feeding counselling will be done to mothers

Behavioral: counselling

Video demonstration

ACTIVE COMPARATOR

Video demonstration to mothers on the advantages of exclusive breast feeding

Behavioral: video demonstration

Standard Care

NO INTERVENTION

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

Interventions

video will be shown to mothers

Video demonstration
counsellingBEHAVIORAL

breast feeding counselling

counselling

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Interventions

Counseling

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr Kanchan Sharma
Organization
Deen Dayal Upadhaya Hospital, New Delhi

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DNB resident

Study Record Dates

First Submitted

September 22, 2009

First Posted

September 24, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 24, 2013

Results First Posted

May 24, 2013

Record last verified: 2013-04