Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country
| ISRCTN | ISRCTN50930504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50930504 |
| Protocol serial number | N/A |
| Sponsor | University College London |
| Funder | Pulitzer Foundation |
- Submission date
- 31/03/2015
- Registration date
- 17/04/2015
- Last edited
- 27/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
East Africa is suffering from devastating droughts and, in Ethiopia, it is estimated that there are 652,000 malnourished children under the age of five in need of emergency food. Malnutrition prevents a child from developing normally and can often lead to death. It also has a negative effect on the relationship between a parent and child. We know that parental support of a child, such as playing with toys with them, has a positive effect on a childs’ development. However, in many developing countries only 10-40% of parents give stimulating materials such as toys to their child. Also, for varying reasons many parents don’t play with their children. We aim to improve this situation by using a simple intervention called Emotional Stimulation (ES). ES was developed by Play Therapy Africa to help mothers reconnect more fully with their malnourished child. Parents learn simple activities such as games that they can play with their children. In this study, youths and Health Extension Workers (HEW) who staff Health Posts attended by parents of malnourished children will be trained to teach parents ES and Nutritional Education (NE). NE teaches parents important information about their children, such as dietary needs and hygiene. Either ES or NE will be taught to parents alongside the provision of emergency food. The aim of this study is to see whether ES is better than NE at helping children to recover from malnutrition in Ethiopia.
Who can participate?
Children with severe acute malnutrition.
What does the study involve?
Health Posts (intervention sites) are randomly put into one of two groups and patients will receive either ES or NE depending on which Health Post they attend. Health Posts are staffed by a HEW and youths trained to give ES or NE to parents and/or caregivers. Each family participating in the study receives 12 weeks treatment with either ES or NE.
What are the possible benefits and risks of participating?
This study may benefit participants by improving nutrition and family bonding. The results will also be used to see whether ES could be used in the wider populations in East Africa that are severely affected by drought.
Where is the study run from?
Play Therapy Africa (Ethiopia)
When is the study starting and how long is it expected to run for?
February 2012 to August 2012
Who is funding the study?
Pulitzer Foundation (UK)
Who is the main contact?
Prof P Fonagy
p.fonagy@ucl.ac.uk
Contact information
Public
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
| Phone | +44 (0) 20 7679 1943 |
|---|---|
| p.fonagy@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country: a randomised controlled trial |
| Study objectives | An Emotional Stimulation (ES) designed to improve mother-child interaction will lead to a greater increase in weight gain in severely malnourished children than Nutritional Education (NE) alone. |
| Ethics approval(s) | 1. University College London Research Ethics Committee, 15/09/2011, ref: 3325/001 2. Federal Democratic Republic of Ethiopia Ministry of Science and Technology Ethics Review Committee, 15/11/2011, ref: 310/510/04 |
| Health condition(s) or problem(s) studied | Severe acute malnutrition |
| Intervention | 1. Emotional Stimulation (ES): a brief, structured, intense psychosocial bonding exercise taught to participating mothers 2. Nutritional Education (NE): participating mothers are given information about the link between good nutrition and health based on the Ethiopian Government’s information pack drawn up to support mothers with malnourished infants and young children |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Body Mass Index (BMI) of infants measured by health extension workers who will record height and weight measurements at weekly intervals for 12 weeks |
| Key secondary outcome measure(s) |
Secondary measures will be collected by data collectors at baseline and at 4, 6, 8 and 12 weeks until discharge: |
| Completion date | 31/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 432 |
| Key inclusion criteria | 1. Age between 6 months and 5 years 2. Severe acute malnutrition defined as 3 SD below WHO published norms of height or forearm skin-fold thickness less than 110mm 3. Pass appetite test 4. Sufficient family involvement to ensure intervention |
| Key exclusion criteria | 1. Serious medical complications requiring referral for inpatient treatment 2. Clinically apparent congenital abnormality 3. Preterm birth (<37 weeks gestation) or birth weight > 2SD below weight/gestation limit |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Ethiopia
Study participating centre
Ethiopia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/11/2019: Links to two theses have been added to the publication and dissemination plan.
