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

Malnutrition Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407224
• Other study ID #: 09-000076-AT10,EMI
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2011
• Last updated: July 31, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Eminence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 5 Months

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malnutrition

Intervention

Behavioral:
• Improve Early Breastfeeding
One arm got only training, another arm training and supervision and third arm without any intervention as control.

Locations

Country	Name	City	State
Bangladesh	Eminence	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Eminence	University of California, Davis

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased proportions of mothers who follow the recommended infant feeding behaviors	Practice related to early breastfeeding and cord clumping	six months intervention	Yes
Secondary	Improve practice on breastfeeding, early initiation and cord clumping .	Evaluation studies are carried out before and after six months of intervention	six months intervention	Yes
Secondary	Improved capacity of TBAs on breastfeeding counseling and knowledge.	Increase capacity of TBAs on breastfeeding counseling and knowledge.	Six months	Yes

External Links

•   RCT of early breastfeeding practices in Bangladesh