Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/10/2013
Date assigned
09/12/2013
Last edited
09/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The SNACK (Santé Nutritionnelle à Assise Communautaire à Kayes [Community Nutrition and Health Program in Kayes]) program is piloted by the World Food Program (WFP) in three districts of the Kayes region in Mali. The goal is to improve nutrition of mothers and children through a package of activities in nutrition and health delivered through community workers and community health centers (CSCOM). WFP is planning to carry out a new component within the SNACK project (Cash for Nutrition Awareness - CNA) from January 2014 in the same area. This component will provide cash to women during the first 1000 days (pregnancy, lactation and the child’s first 2 years) and women will have to use health services during this period in return. The expected result of the CNA component is to optimize the growth of the baby during pregnancy and early childhood. In addition, the CNA component will test whether distributing supplements to children 6-24 months of age also results in better growth of children during early childhood. Our objective is to evaluate the impact of these treatments on children’s growth.

Who can participate?
Pregnant/lactating women and infants/young children in their first two years of age are the target group in the CNA program, because they are particularly vulnerable to poor nutrition and its long-term devastating consequences on survival, health, and well-being. Pregnant women will be recruited into the program when they come for prenatal consultation. Women with children less than 12 months of age will also be recruited. Once recruited, women (and their infant/child) will be included in the program until their child reaches 24 months old.
Only 12.0 to 41.9 month old children and their mothers will participate to the impact evaluation study.

What does the study involve?
Women and children will be randomly allocated to one of four groups:
Group A (control group): women and children receive SNACK activities only
Group B (intervention): women and children receive SNACK activities and cash
Group C (intervention): women and children receive SNACK activities and children receive supplements (Plumpy’doz®).
Group D (intervention): women and children receive SNACK activities, women receive the cash transfer over a maximum of 33 months and 6-24 month old children receive supplements (Plumpy’doz®)
For the evaluation study, samples of 12.0-41.9 month old children and their mothers will be surveyed right before the program starts (baseline) and at the end of the program (endline). Women will have to answer questions about what happened during their pregnancy, what they eat, their knowledge in nutrition, hygiene and health, their habits, as well as questions about their child’s health and nutrition. Height and weight of both mothers and children will be measured.

What are the possible benefits and risks of participating?
Participants will benefit from interventions which are expected to provide a better nutrition to 6-24 month old children and a better health monitoring during and after pregnancy. This should result in a reduction of illness and growth retardation in children. The whole community will also benefit from the program since the study aims to improve this particular intervention as well as this type of interventions in general. The control group will receive SNACK activities which aims to improve health and nutrition of mothers and children.
The study does not present any risk for participants, as there will be only questionnaires and painless and non-invasive measurements. There should be no side effects in any of the groups.

Where is the study run from?
The CNA component is being set up in all functioning health centers (CSCOM) in three districts of the Kayes region, Mali: Bafoulabe, Diema and Yelimane. The study will take place in almost all of these CSCOM (76) and associated villages.

When is study starting and how long is it expected to run for?
CNA component: duration of 4 years, starting in January 2014.
Baseline survey for the evaluation: duration of 40 days, starting early November 2013.
Endline survey for the evaluation: duration of 40 days, starting early November 2016.
The study is expected to last 3 years in total.

Who is funding the study?
World Food Program (Mali), International Food Policy Research Institute (USA), UNICEF (Mali), Research Institute for Development (France).

Who is the main contact?
Dr Mathilde Savy
mathilde.savy@ird.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mathilde Savy

ORCID ID

Contact details

IRD-LARTES
Camp Jérémy
IFAN
Dakar
BP 206
Senegal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized controlled trial to determine whether distribution of cash and/or nutritive supplements during pregnancy and infancy improves the nutritional status of mothers and young children

Acronym

CNA/SNACK

Study hypothesis

It is hypothesised that:
1. The cash transfers used to enhance utilization of preventive health care services during the first 1,000 days (from conception to the 2 years of the child) will optimize growth in utero and during infancy and early childhood.
2. The distribution of micronutrient-fortified lipid-based supplements to 6-24 month old (mo) children will optimize growth in early childhood.
3. The combination of cash transfers to women during the 1000 days and distribution of micronutrient-fortified lipid-based supplements to 6-24 mo children will further optimize growth in utero and during infancy/early childhood.

The null hypothesis is that there will be no difference in nutritional indicators between treatment groups. This may arise for hypotheses 1 and 3 if the quality of the preventive health care services is not good enough in the area. This may arise for hypothesis 2 if the supplement (or part of it) is not eaten by the target child (shared with other family members, sold to someone else, etc.)

Ethics approval

1. Ethics Committee of the Medicine Faculty of Bamako, Mali (Comité d’Ethique de la Faculté de Médecine, Bamako, Mali); study submitted on 8th October 2013; oral presentation of the study to the Ethics committee board on 26th October 2013
2. Consultative Committee of Deontology and Ethics (Comité Consultatif de Déontologie et d’Ethique) of Research Institute for Development [Institut de Recherche pour le Développement (IRD)]

Study design

Three-year cluster-randomised controlled trial, with repeated cross-sectional surveys (baseline, mid-term and endline)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Growth retardation

Intervention

CSCOMs (Centre de Santé Communautaire [Community Health Centres]) were randomized to treatment or control group.
Group A (control group): women and children receive SNACK activities only
Group B (intervention): in addition to SNACK activities, women receive a cash transfer worth 1500 FCFA (~3 US $) per month over a maximum of 33 months (=1000 days)
Group C (intervention): in addition to SNACK activities, 6-24 mo-old children receive supplements (Plumpy’doz®).
Group D (intervention): in addition to SNACK activities, women receive the cash transfer over a maximum of 33 months and 6-24 mo-old children receive supplements (Plumpy’doz®)

Joint sponsor:
International Food Policy Research Institute
2033 K St, NW
Washington, DC 20006-1002
USA
Phone:+1 202-862-5600
Fax:+1 202-467-4439
Email: ifpri@cgiar.org

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Children’s stature after 3 years of intervention, expressed in Height-for-Age Z score
2. Mean birth weight after 1, 2 and 3 years

Secondary outcome measures

1. Use of preventive health care services during pregnancy, for delivery and during early childhood (pregnancy and post-natal care)
2. Infant and Young Children Feeding practices (IYCF indicators including dietary diversity)
3. Weight-for-Height Z score
4. Child development and well being
5. Knowledge, attitude and practices towards nutrition, hygiene and health

Overall trial start date

07/11/2013

Overall trial end date

17/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

12.0-41.9 mo-old children and their mothers willing to participate in the study, living in the villages surrounding the CSCOMs (Health Centers)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

5016 children (12.0-41.9 mo old) and their mothers.

Participant exclusion criteria

Children and mothers having mental or physical disability that could affect growth and well-being.

Recruitment start date

07/11/2013

Recruitment end date

17/12/2016

Locations

Countries of recruitment

Mali

Trial participating centre

IRD-LARTES
Dakar
BP 206
Senegal

Sponsor information

Organisation

Research Institute for Development [Institut de Recherche pour le Développement (IRD)]

Sponsor details

Immeuble Le Sextant
CS 90009
44 Boulevard de Dunkerque
Marseille
13572
France

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

International Food Policy Research Institute, Washington DC (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Food Program (Mali)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UNICEF (Mali)

Alternative name(s)

United Nations Children's Emergency Fund

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United States of America

Funder name

Institut de recherche pour le développement (IRD) (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes