Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country

• Register: ISRCTN
• Last refreshed on: 6 January 2020
• Main ID: ISRCTN50930504
• Date of registration: 17/04/2015
• Prospective Registration: No
• Primary sponsor: University College London
• Public title: Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country
• Scientific title: Emotional stimulation as a cost-effective addition to emergency food intervention for malnutrition in a low income country: a randomised controlled trial
• Date of first enrolment: 01/02/2012
• Target sample size: 432
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN50930504
• Study type: Interventional
• Study design: Cluster randomised controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Ethiopia

Contacts

• Name: Peter Fonagy

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Severe acute malnutrition
Nutritional, Metabolic, Endocrine
Malnutrition

Intervention(s)

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

Primary Outcome(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

Secondary Outcome(s)

Secondary measures will be collected by data collectors at baseline and at 4, 6, 8 and 12 weeks until discharge:
1. Ages and Stages Questionnaire
2. General Health Questionnaire
3. Pearlin and Schoolers’ seven-item scale
4. Global Rating Scale
5. Coding Interactive Behaviour Scale
6. Quality of interaction between parent and child (Ainsworth Sensitivity Coding Scale)
7. Parents’ perception of the child (qualitative interview)
8. The Bayley Scales will be administered to a sub-sample of randomly identified cases by a supervisor trained in the assessment of infants

Secondary ID(s)

N/A

Source(s) of Monetary Support

Pulitzer Foundation

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 31/08/2012