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CompletedNCT01407224iycfchUpdated Aug 2, 2011

Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices

A Phase 1 interventional study of Improve Early Breastfeeding in Malnutrition, sponsored by Eminence. Completed at 1 site in Bangladesh. Open to participants aged 1 Day to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-02.

Sponsored by Eminence · Phase 1, Interventional, and Health services research

Phase
Phase 1
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
1 Day to 5 Months
Sex
All
01

Study 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.

Read the detailed description

Suboptimal early infant feeding practices are the norm in Bangladesh, and contribute to its poor infant health and nutrition. However, the modern health services are unable to help because approximately 85% of births take place at home. The Government has begun the huge process of training the informal community traditional birth attendants (TBAs) who, along with community volunteers (CVs), deliver the majority of babies, especially in the rural areas. The proposed operations research will take place in one of the poorest rural districts. It will compare the cost effectiveness of practical training of these relatively uneducated community members, with or without supportive supervision in improving early infant feeding practices, using a cluster-randomized study design. The practices to be measured before and after on probability samples include: 1) delayed cord clamping, 2) early skin to skin contact and 3) newborn-led initiation of breastfeeding within one hour of birth, 4) avoidance of the traditional prelacteal feeds, and 5) exclusive breastfeeding, at least for the early months. Costs will be carefully monitored so as to compare the cost per behavior improved per infant.

02

Conditions studied

  • Malnutrition

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Keywords

  • Exclusive Breastfeeding
  • Skin to skin contact
  • Cord Clumping
  • Prelactial feeding
03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's enrollment of 1,200 is above the median of 90 across 1,135 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

This is the only study on the registry with Eminence as lead sponsor.

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

04

Who can participate

Ages eligible
1 Day to 5 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • First trimester women and lactating women of children ages 6 to 23 months.
05

Study design

Phase
Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
1,200 participants (actual)

Study arms

  • Experimental
    Only training

    Training on Early Breastfeeding Practices to front line health workers

    Behavioral: Improve Early Breastfeeding

  • Active comparator
    Training and supervision

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

    Behavioral: Improve Early Breastfeeding

  • No intervention
    Control

    No intervention such as training or supervision

    Behavioral: Improve Early Breastfeeding

Interventions

  • BehavioralImprove Early Breastfeeding

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

    Also known as: IYCFCH

06

What researchers measure

Primary outcomes

  1. Increased proportions of mothers who follow the recommended infant feeding behaviors

    Practice related to early breastfeeding and cord clumping

    Time frame: six months intervention

Secondary outcomes

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

    Evaluation studies are carried out before and after six months of intervention

    Time frame: six months intervention

  2. Improved capacity of TBAs on breastfeeding counseling and knowledge.

    Increase capacity of TBAs on breastfeeding counseling and knowledge.

    Time frame: Six months

07

Study locations

1 site
  • Eminence
    Dhaka, 1207, Bangladesh
08

References and documents

Publications

  • 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
  • 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. PubMed 36282618 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01407224
Lead sponsor
Eminence
Collaborators
University of California, Davis
First posted
Aug 2, 2011
Start date
May 2010
Primary completion
May 2011
Completion
Jun 2011
Last update
Aug 2, 2011

Study contacts

DR. Shamim Talukder, M.Phil
principal investigator · Eminence

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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