- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407224
Assessing Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (iycfch)
July 31, 2011 updated by: Eminence
Assessing the Cost and Effectiveness of Training and Supervision of Front Line Workers on Early Breastfeeding Practices (Bangladesh)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dhaka, Bangladesh, 1207
- Eminence
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 5 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Only training
Training on Early Breastfeeding Practices to front line health workers
|
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Names:
|
|
Active Comparator: Training and supervision
Training as well as supervision by field supervisor for six months intervention
|
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Names:
|
|
No Intervention: Control
No intervention such as training or supervision
|
One arm got only training, another arm training and supervision and third arm without any intervention as control.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increased proportions of mothers who follow the recommended infant feeding behaviors
Time Frame: six months intervention
|
Practice related to early breastfeeding and cord clumping
|
six months intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve practice on breastfeeding, early initiation and cord clumping .
Time Frame: six months intervention
|
Evaluation studies are carried out before and after six months of intervention
|
six months intervention
|
|
Improved capacity of TBAs on breastfeeding counseling and knowledge.
Time Frame: Six months
|
Increase capacity of TBAs on breastfeeding counseling and knowledge.
|
Six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: DR. Shamim Talukder, M.Phil, Eminence
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 30, 2011
First Submitted That Met QC Criteria
July 31, 2011
First Posted (Estimate)
August 2, 2011
Study Record Updates
Last Update Posted (Estimate)
August 2, 2011
Last Update Submitted That Met QC Criteria
July 31, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-000076-AT10,EMI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malnutrition
-
HAN University of Applied SciencesFrieslandCampina; HAS Hogeschool; Centre of Expertise Food (CoE Food); SligroCompletedMalnutrition; Protein | Protein MalnutritionNetherlands
-
Mairaj NoorCompletedMalnutrition (Calorie) | Protein-energy MalnutritionPakistan
-
University of ExeterRecruitingMalnutrition Elderly | Protein MalnutritionUnited Kingdom
-
Centre hospitalier Henri Mondor d'AurillacNot yet recruitingMalnutrition Severe | Malnutrition; ModerateFrance
-
Erasmus Medical CenterNot yet recruitingMalnutrition or Risk of MalnutritionNetherlands
-
International Centre for Diarrhoeal Disease Research...GlaxoSmithKline; Stanford UniversityCompletedMalnutrition | Malnutrition in Children | Child MalnutritionBangladesh
-
University of Nove de JulhoUnknownMalnutrition, ChildBrazil
-
Aga Khan UniversityAction Contre la FaimCompletedEvaluation of the Effectiveness and Impact of Community Case Management of Severe Acute MalnutritionSevere MalnutritionPakistan
-
University of California, San FranciscoThrasher Research Fund; Centre de Recherche en Sante de Nouna, Burkina FasoRecruitingAnemia | Malnutrition, Child | Malnutrition, Infant | Hemoglobin Level Measurement | Malnutrition or Risk of MalnutritionBurkina Faso
-
UNICEFSave the ChildrenCompletedSevere MalnutritionCongo, The Democratic Republic of the
Clinical Trials on Improve Early Breastfeeding
-
University of Colorado, DenverCenters for Disease Control and PreventionCompleted
-
Boston UniversityBill and Melinda Gates Foundation; HE2RO, University of the WitwatersrandRecruiting
-
Qingdao Municipal HospitalCompletedNeonatal HypoglycemiaChina
-
Ana Maria LinaresCompletedBreast Feeding, Exclusive
-
Maastricht University Medical CenterRadboud University Medical Center; UMC Utrecht; Erasmus Medical Center; Albert... and other collaboratorsRecruitingStroke | Stroke (CVA) or TIA | Stroke Ischemic | Ischemic Cerebral Infarction | Carotid Artery Stenosis Symptomatic | Carotid Arteriosclerosis | TIA (Transient Ischemic Attack) | Atherosclerosis Cerebral Infarction | Intraplaque Hemorrhage | AtherosclerosesNetherlands
-
University Hospital, GrenobleRéseau Périnatal Alpes-IsereUnknownPregnancy Complications Nos | Labor/Delivery Problems Nos | Vitality; NewbornFrance
-
Burdur Mehmet Akif Ersoy UniversityCompletedPain Management | Newborn | Breastfeeding | Needlestick Injuries | Wounds, Penetrating | VibrationTurkey
-
Dokuz Eylul UniversityCompletedPain, Acute | ComfortTurkey
-
Taipei Medical UniversityCompletedPregnancy Related | Safety Issues | Breastfeeding | Newborn; FitTaiwan
-
University of VirginiaBoston University; Washington University School of Medicine; National Institute... and other collaboratorsRecruitingInfant Death | Breastfeeding | Sudden Infant Death Syndrome Without Mention of AutopsyUnited States