ISRCTN ISRCTN15000469
DOI https://doi.org/10.1186/ISRCTN15000469
Protocol serial number ICDDR,B #2006-007
Sponsor International Centre for Diarrhoeal Diseases Research (Bangladesh)
Funders Department for International Development in Bangladesh (Bangladesh) (grant no.: 00479), Social Science and Humanities Research Council of Canada (Canada) (grant no.: 861-2006-0033)
Submission date
10/07/2007
Registration date
04/09/2007
Last edited
17/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Frances Aboud
Scientific

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

Study information

Primary study designInterventional
Study designCluster randomised controlled trial, with villages being the clusters randomly assigned to intervention or control. Mothers are not blind; research assistants are blind.
Secondary study designRandomised controlled trial
Scientific titleResponsive Complementary Feeding in Bangladesh
Study acronymCRF
Study objectives1. 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(s)Received from the International Centre for Diarrhoeal Diseases Research Bangladesh ICDDR,B) in February 2006 (ref: #2006-007).
Health condition(s) or problem(s) studiedMalnutrition
InterventionFive 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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.

Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration200
Total final enrolment202
Key inclusion criteria1. 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
Key exclusion criteriaChildren too ill or disabled to feed themselves.
Date of first enrolment01/05/2007
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Bangladesh
  • Canada

Study participating centre

Department of Psychology
Montreal
H3A 1B1
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2008 17/05/2019 Yes No

Editorial Notes

17/05/2019: Publication reference and total final enrolment added.