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

Primary Purpose

Malnutrition

Status

Completed

Phase

Phase 1

Locations

Bangladesh

Study Type

Interventional

Intervention

Improve Early Breastfeeding

About this trial

This is an interventional health services research trial for Malnutrition focused on measuring Exclusive Breastfeeding, Skin to skin contact, Cord Clumping, Prelactial feeding

Eligibility Criteria

1 Day - 5 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Eminence

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Only training

Training and supervision

Control

Arm Description

Training on Early Breastfeeding Practices to front line health workers

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

No intervention such as training or supervision

Outcomes

Primary Outcome Measures

Increased proportions of mothers who follow the recommended infant feeding behaviors

Practice related to early breastfeeding and cord clumping

Secondary Outcome Measures

Improve practice on breastfeeding, early initiation and cord clumping .

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

Improved capacity of TBAs on breastfeeding counseling and knowledge.

Increase capacity of TBAs on breastfeeding counseling and knowledge.

Full Information

NCT ID

NCT01407224

First Posted

June 30, 2011

Last Updated

July 31, 2011

Sponsor

Eminence

Collaborators

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT01407224

Brief Title

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

Acronym

iycfch

Official Title

Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eminence

Collaborators

University of California, Davis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition

Keywords

Exclusive Breastfeeding, Skin to skin contact, Cord Clumping, Prelactial feeding

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Only training

Arm Type

Experimental

Arm Description

Training on Early Breastfeeding Practices to front line health workers

Arm Title

Training and supervision

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention such as training or supervision

Intervention Type

Behavioral

Intervention Name(s)

Improve Early Breastfeeding

Other Intervention Name(s)

IYCFCH

Intervention Description

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

Primary Outcome Measure Information:

Title

Increased proportions of mothers who follow the recommended infant feeding behaviors

Description

Practice related to early breastfeeding and cord clumping

Time Frame

six months intervention

Secondary Outcome Measure Information:

Title

Improve practice on breastfeeding, early initiation and cord clumping .

Description

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

Time Frame

six months intervention

Title

Improved capacity of TBAs on breastfeeding counseling and knowledge.

Description

Increase capacity of TBAs on breastfeeding counseling and knowledge.

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

5 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Lactating women of children ages 0 to 5 months and pregnant women with second and third trimester Exclusion Criteria: First trimester women and lactating women of children ages 6 to 23 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

DR. Shamim Talukder, M.Phil

Organizational Affiliation

Eminence

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eminence

City

Dhaka

ZIP/Postal Code

1207

Country

Bangladesh

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

background

PubMed Identifier

36282618

Citation

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.

Results Reference

derived

Links:

URL

http://www.eminence-bd.org

Description

RCT of early breastfeeding practices in Bangladesh

Learn more about this trial

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

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