Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Concern Worldwide (also see has been implementing unconditional cash transfers (UCT) as part of their humanitarian intervention during the lean season for some years. The aim of this study is to assess the impact of two different UCT interventions on child under nutrition.

Who can participate?
Households defined as the most vulnerable by Concern Worldwide and targeted to receive cash transfers, with women aged 15-49 years and children aged 6-59 months. A small sample of non-recipients will also be investigated.

What does the study involve?
Households around about 20 distributions points will be randomly allocated to one of two groups.
One group will receive a standard seasonal UCT intervention that provides sufficient cash to households to cover 75% of the household food needs over the four-month period of the lean season (June – September). The other group will receive an earlier seasonal UCT intervention that provides the same total amount of cash but distributed over a longer period of six months, starting two months earlier (April – September). Between June and September, both groups will also receive a supplementary feeding intervention for children aged 6 to <24 months and pregnant and lactating women, and health, hygiene and nutrition education messages.

What are the possible benefits and risks of participating?
The population in Tahoua, as a whole, should benefit from the future improvement in the design of cash transfer programmes. Individual participants will get their haemoglobin results and will be referred to health facilities if identified as anaemic using local diagnostic cut-offs. They will also 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. A finger stick blood sample will be collected which may cause some minor discomfort.

Where is the study run from?
Tahoua region, Niger

When is the study starting and how long is it expected to run for?
June 2014 to December 2015

Who is funding the study?
Department for International Development (DFID), UK

Who is the main contact?
Dr Andrew Seal

Trial website

Contact information



Primary contact

Dr Andrew Seal


Contact details

UCL Institute for Global Health
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

Project ID 6543/001

Study information

Scientific title

A cluster randomised controlled trial of the effectiveness and cost effectiveness of
early initiation and longer duration of emergency/seasonal unconditional cash transfers on children’s nutritional status in Tahoua, Niger


REFANI-N (Research on Food Assistance for Nutritional Impact - Niger)

Study hypothesis

An earlier, extended emergency/seasonal unconditional cash transfer of equal value and longer duration than the standard intervention reduces the prevalence of acute malnutrition in children 6-59 months of age in the very poor, targeted households after six months / by the end of the lean season.

Ethics approval

1. Ministry of Public Health National Ethics Committee, Niamey, Niger, 27/11/2014, ref: 021/2014/CCNE
2. Research Ethics Committee of University College London, 30/01/2015, Project ID: 6543/001

Study design

Cluster randomised trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

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


Child undernutrition


Cash transfers to households classified as very poor.

Comparing standard seasonal UCT intervention (done over the four-month period of the lean season (June – September) to earlier seasonal UCT intervention (same amount of cash but distributed over a six-month period, starting two months earlier, April – September).

To evaluate the nutrition impact of these two interventions over the lean season we will recruit a study cohort, inviting participation from all beneficiary households with an expected population of 3,500 children, aged 6-59 months. This will be adequate to detect a difference in 5 percentage points in the prevalence of global acute malnutrition between interventions arms, which is our primary outcome measure.

In addition, we aim to measure whether this intervention has a nutritional impact on the wider community. To achieve this, we will randomly recruit a sample of non-beneficiary households. We will also undertake extra in-depth studies to assess changes in household expenditure, women’s well being and empowerment, food security, and the prevalence of anaemia as measured by haemoglobin concentration in blood. These quantitative and qualitative process evaluation studies will enhance our understanding of how the interventions work or fail to work. Data collection will involve anthropometric measurements such as weight, length or height, and mid-upper arm circumference in women and children using standard methods. Second, measuring haemoglobin concentration from peripheral blood in non-pregnant women and children using a portable photometer, HemoCue, following standard methods. Third, the use of standard questionnaire tools on socio-economic status, health, and health seeking behaviours that will be adapted to the local context, translated and piloted.

Intervention type



Drug names

Primary outcome measures

Prevalence of global acute malnutrition (weight-for-height <-2 z scores (WHO 2006 growth standards) and/or nutritional oedema) in children 6-59 months

Data collection will take place before and after the intervention (that is March/April and September/October for the baseline and end line data, respectively).

Secondary outcome measures

1. Prevalence of global acute malnutrition (mid upper arm circumference (MUAC) <11.5 cm and/or nutritional oedema) in children 6-59 months
2. Mean weight-for-height (WHO 2006 growth standards) in children 6-59 months
3. Mean MUAC in children 6-59 months
4. Mean haemoglobin in children aged 6-59 months
5. Prevalence of anaemia in children aged 6-59 months
6. Mean haemoglobin in women aged 15-49 years
7. Prevalence of anaemia in women aged 15-49 years
8. Household Diet Diversity Score
9. Individual Diet Diversity Score in children aged 6-59 months
10. Individual Diet Diversity Score in women aged 15-49 years
11. Household expenditure
12. Cost effectiveness of the modified cash transfer intervention

Data collection will take place before and after the intervention (that is March/April and September/October for the baseline and end line data, respectively).

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. The geographical inclusion criteria is settlements within the Affala and Takanamatt Communes of Tahoua district, Niger.
2. Within this geographical area settlements that have been previously targeted for inclusion within the Concern Worldwide humanitarian cash transfer programme, will be eligible for inclusion in the study. (Within eligible settlements, only households defined as the most vulnerable by Concern Worldwide are targeted to receive cash transfers.) Study clusters will include one or more settlements and will be randomly allocated to one of two study arms in a public randomisation event.
3. Within clusters, households receiving a cash transfer will be exhaustively sampled and a sub-sample of households not receiving the cast transfer will randomly selected.
4.Within these selected households, two groups of individuals will be exhaustively sampled::
4.1 Women aged 15-49 years
4.2 Children aged 6-59 months

Participant type


Age group




Target number of participants

All eligible women and children within the randomly selected clusters. 4000 children (6-59 months) and 3000 women (15-49 years); 7000 in total

Participant exclusion criteria

1. Households without children aged 6-59 months
2. Severely disabled individuals on which anthropometric measures cannot be taken
3. Individuals confined to bed due to illness

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre


Sponsor information


University College London

Sponsor details

Gower Street
United Kingdom
+44 (0)20 7679 2000

Sponsor type




Funder type


Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Publish the main trial results and any associated analysis within one year of the end of the data collection.

Intention to publish date


Participant level data

Stored in repository

Results - basic reporting

Publication summary

2015 protocol in:

Publication citations

Additional files

Editorial Notes

20/06/2016: Publication reference added.