Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICDDR,B #2006-007
Study information
Scientific title
Acronym
CRF
Study hypothesis
1. Mothers in the intervention will show more responsive feeding than the comparison group.
2. Children in the intervention will show more self-feeding, take more mouthfuls of food, and gain more weight (weight for age) than comparison children.
Ethics approval
From International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B) in February 2006.
Study design
Cluster randomised controlled trial, with villages being the clusters randomly assigned to intervention or control. Mothers are not blind; research assistants are blind.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Malnutrition
Intervention
Five weekly group sessions given by trained village peer educators to mothers and their children using a Manual for Responsive Feeding. Mothers observe a demonstration and then practice the behaviour with their child.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Mother responsive feeding. Child self-feeding
2. Number of mouthfuls of food taken by child
The time points for measurements are as follows: baseline, 2 weeks post intervention, 4 months post intervention.
Secondary outcome measures
Child's weight, measured at baseline, 2 weeks post intervention, 4 months post intervention.
Overall trial start date
01/04/2006
Overall trial end date
30/11/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Living in three unions in Gazipur district of Bangladesh
2. Mothers of children 12 to 24 months of age
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Children too ill or disabled to feed themselves
Recruitment start date
01/04/2006
Recruitment end date
30/11/2006
Locations
Countries of recruitment
Bangladesh
Trial participating centre
Department of Psychology
Montreal
H3A 1B1
Canada
Sponsor information
Organisation
International Centre for Diarrhoeal Diseases Research (Bangladesh)
Sponsor details
Mohakhali (or GPO 128)
Dhaka
1212
Bangladesh
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Department for International Development in Bangladesh (Bangladesh)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list