Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/07/2007
Date assigned
04/09/2007
Last edited
04/09/2007
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 than comparison children

Ethics approval

Received from the International Centre for Diarrhoeal Diseases Research Bangladesh ICDDR,B) in February 2006 (ref: #2006-007).

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

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Malnutrition

Intervention

Five weekly group sessions and booster session 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. Group discussions on how to handle feeding problems, such as refusals, without forceful feeding. Control mothers will receive a reminder of their nutrition education on foods to feed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mother responsive feeding
2. Child weight, self-feeding, and number of mouthfuls eaten

The time points for measurements are as follows: baseline, 2 weeks post intervention, 4 months post intervention.

Secondary outcome measures

1. Foods fed and messages recalled
2. Possibly other maternal feeding behaviours such as non-responsive encouragement and speech

The time points for measurements are as follows: baseline, 2 weeks post intervention, 4 months post intervention.

Overall trial start date

01/05/2007

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Living in three unions in Jaldhaka, in the north of Bangladesh
2. Mothers and their children 8 to 20 months of age
3. Must have started complementary food

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

01/05/2007

Recruitment end date

30/11/2007

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) (grant no.: 00479)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Social Science and Humanities Research Council of Canada (Canada) (grant no.: 861-2006-0033)

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