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 childs 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 childrens 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 (Plumpydoz®).
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 (Plumpydoz®)
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 childs 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
Study website
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
1. Ethics Committee of the Medicine Faculty of Bamako, Mali (Comité dEthique 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 dEthique) 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
Study setting(s)
Other
Study 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 (Plumpydoz®).
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 (Plumpydoz®)
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
Primary outcome measure
1. Childrens 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 study start date
07/11/2013
Overall study end date
17/12/2016
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Child
Lower age limit
12 Months
Upper age limit
41 Months
Sex
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, Senegal
Study 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
ROR
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 Fund, United Nations Children's Emergency Fund, Fonds des Nations Unies pour l'enfance, Fondo de las Naciones Unidas para la Infancia, صندوق الأمم المتحدة للطفولة, 联合国儿童基金会
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/01/2019 | Yes | No | |
| Results article | results | 01/12/2019 | 01/10/2019 | Yes | No |