Evaluation of a responsive feeding and stimulation intervention
| ISRCTN | ISRCTN17580242 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17580242 |
| Secondary identifying numbers | ICDDR,B #2008-010 |
- 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
Scientific
Department of Psychology
1205 Dr Penfield Avenue
Montreal
H3A 1B1
Canada
Study information
| Study design | Cluster randomised, three-armed, single-blinded field trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2008 |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
H3A 1B1
Canada
Sponsor information
International Centre for Diarrhoeal Diseases Research (Bangladesh)
Research organisation
Research organisation
Mohakhali (or GPO 128)
Dhaka
1212
Bangladesh
| ACravioto@icddrb.org | |
| Website | http://www.icddrb.org/ |
"ROR" |
https://ror.org/04vsvr128 |
Funders
Funder type
Government
Social Science & Humanities Research Council (SSHRC) (Canada) (grant ref: 861-2006-0033)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
17/05/2019: Publication reference and total final enrolment added.
