Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/07/2008
Date assigned
05/09/2008
Last edited
09/10/2008
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 #2008-010

Study information

Scientific title

Acronym

CRF II

Study hypothesis

1. Mothers in the responsive program will show more verbal and nonverbal responsive behaviours in social and feeding interactions with their child, compared to mothers in the regular program. They will also provide more opportunities for stimulation as measured by the Home Observation for Measurement of the Environment (HOME) inventory.
2. Children in the responsive program will show more self-feeding behaviours, more gained weight and length, and better language development compared to the regular program children
3. Children in the responsive program plus iron supplementation will show more development and growth than those in the responsive program without iron

This trial is similar to a previously registered trial (see http://www.controlled-trials.com/ISRCTN15000469), but involves a different dataset, an extra arm to the trial and an extra outcome. Therefore this has been assigned to a different ISRCTN.

Ethics approval

Ethics approval received from the ethics committee of the International Centre for Diarrhoeal Diseases Research Bangladesh (ICDDR,B) in April 2008.

Study design

Cluster randomised, three-armed, single-blinded field trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malnutrition

Intervention

This is a cluster randomised field trial, with villages clusters randomly assigned to one of two interventions or a regular-program control. Mothers are not blinded; data collectors are blinded.

The Mothers in the Responsive Feeding intervention consisted of five weekly group sessions and a booster session given by trained village peer educators to mothers and their children using a Manual for Responsive Feeding and Play. 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.

The Mothers in the Responsive Feeding and Iron Supplement intervention group also received seven sachets of Sprinkles per week and were shown how to add this to the child's food. Iron supplements continued for 6 months.

The Control mothers received the usual behaviour change communication (BCC) knowledge-transfer sessions from a Manual.

All mothers receive a laminated picture to remind them of the messages they learned. The interventions and controls last for six weeks; follow-up data collections occur five months later.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mother: responsive feeding and responsive talking
2. Child:
2.1. Length and weight
2.2. Self-feeding
2.3. Mouthfuls eaten
2.4. Language development

Outcomes are measured at baseline, two weeks after the end of the intervention and five months after the end of the intervention.

Secondary outcome measures

1. Foods fed and messages recalled
2. Other maternal feeding behaviours such as forceful feeding and non-responsive encouragement

Outcomes are measured at baseline, two weeks after the end of the intervention and five months after the end of the intervention.

Overall trial start date

01/04/2008

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Living in four unions in Khansama, 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

Other

Gender

Both

Target number of participants

300

Participant exclusion criteria

Children too ill or disabled to feed themselves.

Recruitment start date

01/04/2008

Recruitment end date

30/12/2008

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
ACravioto@icddrb.org

Sponsor type

Research organisation

Website

http://www.icddrb.org/

Funders

Funder type

Government

Funder name

Social Science & Humanities Research Council (SSHRC) (Canada) (grant ref: 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