Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/01/2016
Date assigned
22/01/2016
Last edited
22/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hunger Is the World’s biggest health problem. More people are killed by hunger every year than AIDS, malaria and tuberculosis combined. Concern Worldwide is an international charity which aims to tackle hunger and transform the lives of the world’s poorest people (also see http://www.actionagainsthunger.org/). It has been running unconditional cash transfers (UCT) (assisting by giving cash to the poor) as part of their humanitarian work in Somalia for some years. The aim of this study is to assess the impact of UCT interventions (or programmes) on child under nutrition.

Who can participate?
Households living in camps for internally displaced people (IDP) on the outskirts of Mogadishu, Somalia who have been assessed to be particularly vulnerable by Concern Worldwide and targeted to receive cash transfers, will be invited to take part. A sample of non-recipients from IDP camps that are not currently receiving cash transfers will also be invited to participate.

What does the study involve?
Households that agree to take part are asked to answer a questionnaire on risk factors for children developing under nutrition. This will cover topics such as household expenditure on food, access to water and sanitation, dietary intake (what they eat), and illness. Children and their mothers are also weighed and their height and mid-upper arm circumference measured so their nutritional status can be assessed. What people think regarding malnutrition, who is most at risk of malnutrition and how useful cash transfers are at tackling malnutrition is collected through interviews and group discussions. The study also collects data to monitor how well the cash transfer programme is running and to monitor factors that may affect the impact that the cash transfer may have. These factors include what other humanitarian interventions are carried out in the study areas.

What are the possible benefits and risks of participating?
The population in Somalia, as a whole, should benefit from the future improvement in the design of cash transfer programmes. Individual participants will benefit from nutritional screening and will be referred to a therapeutic feeding programme if found to be severely malnourished according to anthropometric criteria. Participants will be asked to allocate time to answering the study questionnaires and no material incentives or rewards will be provided.

Where is the study run from?
The study is run by Concern Worldwide Somalia. It takes place in camps for IDP on the outskirts of Mogadishu, Somalia.

When is the study starting and how long is it expected to run for?
October 2013 to December 2016

Who is funding the study?
Department for International Development, UK Government

Who is the main contact?
Dr Andrew Seal

Trial website

Contact information

Type

Public

Primary contact

Dr Andrew Seal

ORCID ID

http://orcid.org/0000-0003-3656-4054

Contact details

UCL Institute for Global Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Project ID 1822/003

Study information

Scientific title

Assessing the role of cash transfer programmes in reducing the risk of acute malnutrition in Somalia

Acronym

REFANI-S (Research on Food Assistance for Nutritional Impact - Somalia)

Study hypothesis

Distribution of cash reduces the risk of IDP (internally displaced people) children, aged 6-59 months, developing acute malnutrition in a peri-urban area of Mogadishu, Somalia

Ethics approval

1. Research Ethics Committee of University College London, 10/12/2015, ref: 1822/003
2. Ministry of Health, Mogadishu,11/08/2015, refs MOH & HS /DGO/0469/August/2015

Study design

Non-randomised cluster controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Child undernutrition

Intervention

This study involves cash transfers to households classified as in need of humanitarian assistance. The Concern unconditional cash transfer (UCT) programme that will be received by the beneficiaries in this study is funded by ECHO. The intervention is a part of normal Concern humanitarian programming and will be separately designed, funded, and implemented from this study. Concern plans to provide a UCT of approximately US$ 90 per household per month to approximately 2,000 households with the aim of providing the most vulnerable families access to food and basic non-food. Concern is running an integrated emergency programme in the Mogadishu area and engaging with local partners and communities to provide piped water for 3,200 IDP households, supporting and equipping Maternal and Child Health and Nutrition (MCHN) centres in the area and two OTPs in Daynile District, Mogadishu.

The clusters being studied comprise camps for internally displaced people within the Afgooye Corridor area of peri-urban Mogadishu. The camps vary in size and contain makeshift, temporary, houses. Some camps are supplied with water and sanitation facilities by the Concern programme. Within this geographical area camps that have been previously targeted for inclusion within the Concern Worldwide humanitarian cash transfer programme will be eligible for inclusion in the intervention arm of the study. A selection of camps from adjacent areas, that are not targeted for cash transfers, will be selected for inclusion in the study as control/comparison clusters. These camps will be selected after the intervention camps are selected for the cash transfer programme.

Households that agree to take part will be asked to answer a questionnaire on risk factors for children developing under nutrition. This will cover topics such as household expenditure on food, access to water and sanitation, dietary intake, and illness. Children and their mothers will also be weighed and their height and mid-upper arm circumference measured so their nutritional status can be assessed. Qualitative information on people's perceptions of malnutrition, risk factors, and the impact of cash transfers will also be collected using interviews and group discussions. The study will also collect data to monitor how well the cash transfer programme is running compared to the planned implementation, and to monitor factors that may affect the impact that the cash transfer may have. These factors will include what other humanitarian interventions are carried out in the study areas.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Individual diet diversity scores of children aged 6-59 months, measured during the baseline survey and during end-line survey after 3 months of intervention
2. Incidence of acute malnutrition in children aged 6-59 months (defined as a mid-upper arm circumference (MUAC) < 12.5 cm and/or nutritional oedema), measured over 6 months of follow-up following the start of the intervention

Secondary outcome measures

1. Prevalence of global acute malnutrition (weight-for-height <-2 z scores (WHO 2006 growth standards) and/or nutritional oedema) in children 6-59 months
2. Mean weight-for-height (WHO 2006 growth standards) in children 6-59 months
3. Household expenditure
4. Household Dietary Diversity Score (24 hour recall)
5. Household Food Insecurity Access Scale score (one month recall)
6. Coping Strategies Index (7 day recall)
7. Access to water and sanitation
8. Infant and Young Child Feeding practices in the under twos
9. Two week retrospective morbidity
10. Treatment sought and received
11. Mean Maternal MUAC
12. Mean Maternal BMI

All measured during the baseline survey before the intervention begins and during the end-line survey after 3 months of intervention.

Overall trial start date

22/10/2013

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. The geographical inclusion criteria is camps for internally displaced people within the Afgooye Corridor area of peri-urban Mogadishu
2. Within this geographical area camps that have been previously targeted for inclusion within the Concern Worldwide humanitarian cash transfer programme will be eligible for inclusion in the study. A selection of camps form adjacent areas, that are not targeted for cash transfers, will also be selected for inclusion in the study as control/comparison clusters
3. Within clusters, a sample of households will be randomly selected for inclusion in the baseline and end-line surveys. Within these selected households, two groups of individuals will be exhaustively sampled: children aged 6-59 months and women aged 15-49 years
4. Children from all households within the clusters will be included in the nutrition surveillance part of the study, which will involve monthly nutritional assessment using MUAC

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

We aim to recruit a total of 1,200 subjects from 20 clusters (10 intervention and 10 control).

Participant exclusion criteria

1. Children with a disability that prevents taking weight or height measures
2. Children with a medical condition that prevents them eating a normal diet
3. Children confined to bed due to illness
4. Children living in a household in which the mother/carer is unable to respond to questions due to a speech or hearing impairment

Recruitment start date

10/02/2016

Recruitment end date

31/08/2016

Locations

Countries of recruitment

Somalia

Trial participating centre

Concern Worldwide Somalia
Mogadishu
N/A
Somalia

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
London
WC1N 1EH
United Kingdom
+44 (0)20 7679 2000
ighadmin@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

Department for International Development, UK Government

Alternative name(s)

Department for International Development, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date

30/01/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes