NCT01407224

Brief Summary

The aim of this operational research is to compare the cost-effectiveness of two methods for capacity building of existing TBAs/CVs to improve rates of delayed cord clamping, early skin to skin contact and infant-led initiation of breastfeeding, to reduce prelacteal feeding and increase early exclusive breastfeeding in research areas of rural Bangladesh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2011

Completed
Last Updated

August 2, 2011

Status Verified

July 1, 2011

Enrollment Period

1 year

First QC Date

June 30, 2011

Last Update Submit

July 31, 2011

Conditions

Keywords

Exclusive BreastfeedingSkin to skin contactCord ClumpingPrelactial feeding

Outcome Measures

Primary Outcomes (1)

  • Increased proportions of mothers who follow the recommended infant feeding behaviors

    Practice related to early breastfeeding and cord clumping

    six months intervention

Secondary Outcomes (2)

  • Improve practice on breastfeeding, early initiation and cord clumping .

    six months intervention

  • Improved capacity of TBAs on breastfeeding counseling and knowledge.

    Six months

Study Arms (3)

Only training

EXPERIMENTAL

Training on Early Breastfeeding Practices to front line health workers

Behavioral: Improve Early Breastfeeding

Training and supervision

ACTIVE COMPARATOR

Training as well as supervision by field supervisor for six months intervention

Behavioral: Improve Early Breastfeeding

Control

NO INTERVENTION

No intervention such as training or supervision

Behavioral: Improve Early Breastfeeding

Interventions

One arm got only training, another arm training and supervision and third arm without any intervention as control.

Also known as: IYCFCH
ControlOnly trainingTraining and supervision

Eligibility Criteria

Age1 Day - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester

You may not qualify if:

  • First trimester women and lactating women of children ages 6 to 23 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eminence

Dhaka, 1207, Bangladesh

Location

Related Publications (2)

  • Dewey KG,Talukder S, Greiner T, Farhana D, Shajedul H, Haider R. Assessing cost and effectiveness of training and supervision for front line health workers to improve breastfeeding practice The Lancet 330(13):913-919,2011

    BACKGROUND
  • Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.

Related Links

MeSH Terms

Conditions

MalnutritionBreast Feeding

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • DR. Shamim Talukder, M.Phil

    Eminence

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2011

First Posted

August 2, 2011

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 2, 2011

Record last verified: 2011-07

Locations