Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/09/2006
Date assigned
13/10/2006
Last edited
11/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frances Aboud

ORCID ID

Contact details

Department of Psychology
1205 Dr Penfield Avenue
Montreal
H3A 1B1
Canada

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 measures

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

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

http://www.icddrb.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes