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

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by:
Eminence
ClinicalTrials.gov Identifier:
NCT01407224
First received: June 30, 2011
Last updated: July 31, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Malnutrition
Behavioral: Improve Early Breastfeeding
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)

Resource links provided by NLM:


Further study details as provided by Eminence:

Primary Outcome Measures:
  • Increased proportions of mothers who follow the recommended infant feeding behaviors [ Time Frame: six months intervention ] [ Designated as safety issue: Yes ]
    Practice related to early breastfeeding and cord clumping


Secondary Outcome Measures:
  • Improve practice on breastfeeding, early initiation and cord clumping . [ Time Frame: six months intervention ] [ Designated as safety issue: Yes ]
    Evaluation studies are carried out before and after six months of intervention

  • Improved capacity of TBAs on breastfeeding counseling and knowledge. [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    Increase capacity of TBAs on breastfeeding counseling and knowledge.


Enrollment: 1200
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Only training
Training on Early Breastfeeding Practices to front line health workers
Behavioral: Improve Early Breastfeeding
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Name: IYCFCH
Active Comparator: Training and supervision
Training as well as supervision by field supervisor for six months intervention
Behavioral: Improve Early Breastfeeding
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Name: IYCFCH
No Intervention: Control
No intervention such as training or supervision
Behavioral: Improve Early Breastfeeding
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Name: IYCFCH

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.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407224

Locations
Bangladesh
Eminence
Dhaka, Bangladesh, 1207
Sponsors and Collaborators
Eminence
University of California, Davis
Investigators
Principal Investigator: DR. Shamim Talukder, M.Phil Eminence
  More Information

Additional Information:
No publications provided

Responsible Party: Kathyrn Dewey and Shamim Hayder Talukder, UC Davis and Eminence
ClinicalTrials.gov Identifier: NCT01407224     History of Changes
Other Study ID Numbers: 09-000076-AT10,EMI
Study First Received: June 30, 2011
Last Updated: July 31, 2011
Health Authority: Bangladesh: Bangladesh Medical Research Council

Keywords provided by Eminence:
Exclusive Breastfeeding
Skin to skin contact
Cord Clumping
Prelactial feeding

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 28, 2014