Evaluation of a responsive feeding and stimulation intervention

ISRCTN	ISRCTN17580242
DOI	https://doi.org/10.1186/ISRCTN17580242
Protocol serial number	ICDDR,B #2008-010
Sponsor	International Centre for Diarrhoeal Diseases Research (Bangladesh)
Funder	Social Science & Humanities Research Council (SSHRC) (Canada) (grant ref: 861-2006-0033)

Submission date: 24/07/2008
Registration date: 05/09/2008
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 design	Interventional
Study design	Cluster randomised, three-armed, single-blinded field trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of a responsive feeding and stimulation intervention
Study acronym	CRF II
Study objectives	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(s)	Ethics approval received from the ethics committee of the International Centre for Diarrhoeal Diseases Research Bangladesh (ICDDR,B) in April 2008.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/12/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	300
Total final enrolment	302
Key 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
Key exclusion criteria	Children too ill or disabled to feed themselves.
Date of first enrolment	01/04/2008
Date of final enrolment	30/12/2008

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 share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011	17/05/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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