Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/03/2015
Date assigned
26/03/2015
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The nutritional situation of children in Pakistan is one of the worst in the world with few improvements seen during the past decade. Wasting (thinness) is particularly high in Sindh Province, especially during the summer lean period. Sindh is also prone to natural disasters, especially flooding, and mitigation strategies are necessary to deal with the increased risk of wasting in children. Cash transfer programmes are an emerging strategy increasingly being used for the prevention of wasting, especially targeted at vulnerable households, who have children at risk of undernutrition, during periods of food insecurity or during emergencies. This study aims to (1) compare the nutrition status of children receiving a seasonal unconditional cash transfer (standard or double) or a food voucher with those receiving standard care only after 6 months and at 1 year; (2) assess the costs and cost-effectiveness of the different interventions; (3) understand the factors that determine the ways in which households use the different transfers; and (4) explore the role of the different processes involved in the study outcomes and how they interact with the context.

Who can participate?
All poor and very poor households with a child or children aged between 6-48 months at the beginning of the study.

What does the study involve?
You will be asked to answer a number of questions relating to your household, yourself and your children. Some of these questions will focus on household expenditures and incomes, some on nutrition, food security and water and sanitation and some on health. You will also be asked to participate in having your height measured and then to help the enumerators to measure your children's weight, height and arm circumference. These measurements will be done every month for 6 months. At 3 points in time (6 months apart) we will also ask you to participate in having a test for anaemia. This will involve a very quick and non-harmful procedure to take a small droplet of blood from your own and then your child/ren’s finger. The whole study takes place over 1 year. You will be visited once a month for the first 6 months and then once again 6 months later. The first visit will require more time, approximately 1 hour; follow-up visits will be shorter than this.

What are the possible benefits and risks of participating?
You (mothers) and you child/children will be regularly tested for the presence of anaemia. If anaemia is present then you will be referred to an ACF treatment centre. Furthermore your children will be assessed for severe wasting, and referred if necessary to the nearest ACF nutrition treatment centre.
For those households receiving a cash transfer (either cash or voucher) an improvement in your economic situation is expected, which could help to improve food security and reduce vulnerability, ultimately improving the nutritional status of you and your children.
The comparison area will continue to receive the same nutrition interventions under the current WINS programme as the intervention arms. Even though there is no additional intervention you will be providing vital information that we will use to support the government and donors to better understand the potential importance of emergency cash transfer programmes as part of the prevention of wasting and anaemia during periods where vulnerabilities are high. If we find that either the cash or the voucher transfer does have an impact on child wasting then this information will be used to direct ACF future cash transfer programming in Dadu.
This study would not just inform programming in Pakistan but also the current global debate around the ‘best’ modality of CTPs that impact nutrition status.
There are minimal risks from participation in this study.

Where is the study run from?
Action Contre la Faim (ACF) base in Dadu town, Dadu Disctrict, in Sindh Province, Pakistan.

When is the study starting and how long is it expected to run for?
From June 2014 to July 2016. Enrolment and data collection will start from April 2015.

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

Who is the main contact?
Bridget Fenn (Principle Investigator)

Trial website

http://www.actionagainsthunger.org/refani

Contact information

Type

Scientific

Primary contact

Ms Bridget Fenn

ORCID ID

Contact details

32 Leopold Street
Oxford
0X4 1TW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6-250215

Study information

Scientific title

A cluster randomised controlled trial of the effectiveness and cost-effectiveness of cash transfer programmes on child nutrition status in Sindh, Pakistan.

Acronym

REFANI-P (Research on Food Assistance for Nutritional Impact - Pakistan)

Study hypothesis

Cash transfer interventions reduce the prevalence of wasting and of anaemia in children less than five years of age from poor and very poor households.
This four-arm cluster randomised controlled trial (with integral economic evaluation and mixed-methods process evaluation) is set in Action Against Hunger | ACF International (ACF) EU-WINS programme villages in Dadu District, Sindh Province, Pakistan. All arms will have access to the ‘standard’ ACF Women and Children/Infant Improved Nutrition in Sindh (EU-WINS) programme. Villages will be randomised to one of four groups receiving either one of two seasonal unconditional cash transfers (intervention), a food voucher (intervention) or the ACF standard care (control).

Ethics approval

1. National Bioethics Committee (NBC) Pakistan, 12/02/2015, ref: 4-87/14/NBC-170/RDC/2304
2. Western International Review Board, 11/03/2015

Study design

Single-centre trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Condition

Low weight-for-height: Wasting or thinness indicates in most cases a recent and severe process of weight loss, which is often associated with acute starvation and/or severe disease.

Intervention

Intervention 1: Seasonal unconditional cash transfer (UCT), with a value of approximately 1500PRs (GBP 9), distributed monthly over 6 months.
Intervention 2: Seasonal unconditional cash transfer (UCT), with a value of approximately 3000PRs (GBP 18), distributed monthly over 6 months.
Intervention 3: Seasonal Food vouchers, with an equivalent value to the smallest UCT 1500PRs (GBP 9), distributed monthly over 6 months.
Control group: Standard care whereby villages will receive the interventions delivered by the ACF WINS programme only.
All arms will get the same elements of the ACF WINS programme

Intervention type

Other

Phase

Drug names

Primary outcome measures

The primary outcome is prevalence of wasting (as measured by weight-for-height Z-score (WHZ) <-2 or the presence of bilateral pitting oedema) in children <5 years old. Wasting will be assessed at baseline and then monthly during the intervention period and then again at 1 year after baseline.

Secondary outcome measures

1. Severe wasting (defined as WHZ <-3 SD or oedema); mean WHZ
2. Low MUAC (children: <125mm & < 115mm, mothers: <230mm & <210mm)
3. Stunting (defined as height-for-age (HAZ) <2 SD; severe stunting <3 SD)
4. Anaemia (children and women); haemoglobin Hb g/dl(means)
5. Body Mass Index (BMI) (non PLW >19 years old) (<16, <17<18.5kg/m2)
6. Morbidity in children (diarrhoea, malaria and respiratory illness).
7. Individual Diet Diversity Score (children and mothers)
1-7 will be assessed at baseline and then monthly during the intervention period and then again at 1 year after baseline.
8. Cost effectiveness of the different cash transfer modalities - will be assessed at the end of the intervention

Overall trial start date

01/06/2014

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Households identified as poor and very poor (according to wealth index criteria) and with a child or children aged 6-48 months
2. Households with children born in the area during the study period

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

5680 children in 2580 households

Participant exclusion criteria

1. Poor and very poor households with no eligible child
2. Households with children who moved to the area within 6 months before the intervention (and may not be typical of households in the village e.g. those migrating due to drought in their area)
3. Households who do not give consent
4. Children who are chronically ill (with prescribed medical treatment)

Recruitment start date

15/04/2015

Recruitment end date

31/05/2015

Locations

Countries of recruitment

Pakistan

Trial participating centre

ACF base Dadu
Dadum Berhamani Housing Society Jamali Colony Behind General Bus stand Sehwan Road
Dadu
-
Pakistan

Sponsor information

Organisation

UK Department for International Development (DFID)

Sponsor details

22 Whitehall
London
SW1A 2EG
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department of International Development (DFID)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish in a variety of journals including open access. We will publish at least three papers; the protocol (August 2015), the main results from the study (April 2016) and the results from the CEA (April 2016). There will be the potential for other papers relating to the process evaluation and the qualitative work, though this is still to be decided. We have, as a consortium, a dedicated research uptake strategy team to organise a thorough dissemination of the research including (apart from journals) conferences, lectures, other relevant non-peer reviewed publications (e.g. Field Exchange), the ACF/REFANI website, and through the DFID R4D open access database.

Intention to publish date

01/08/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26459336

Publication citations

Additional files

Editorial Notes

16/10/2015: Publication reference added.