Plain English Summary
Background and study aims
The cash transfer program is tried by the PdC (Projet de Développement Communautaire), Government of Togo, in five districts of the Kara and Savanes regions in Togo. This program will provide cash to women during the first 1000 days of pregnancy, lactation and the childs first 2 years including attending prenatal visits, attending nutrition, health and hygiene education sessions, birth registration and children schooling. The expected result of the program is to improve growth of the baby during pregnancy and early childhood, and improve childrens well-being and social protection. Our aim is to see if the giving cash to women have an impact on childrens growth, well-being and social protection.
Who can participate?
Pregnant/lactating women and infants/young children under 2 years of age can take part.
What does the study involve?
Women and children will be randomly allocated to one of two groups:
Group A (control group): women and children attend education sessions
Group B (intervention): in addition to the education sessions, women receive a cash transfer worth 5000 FCFA (about 8 euros) per month over a maximum of 30 months (about 1000 days).
The children and their mothers will be seen right before the program starts (baseline) and at the end of the program. Women will have to answer questions about what happened during their pregnancy, what they eat, their knowledge of nutrition, hygiene and health, their habits, as well as questions about their childs health and nutrition. The height and weight of both mothers and children will be measured.
What are the possible benefits and risks of participating?
Participants will benefit from the intervention which is expected to promote better nutrition for children and 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 results of the study will be used to extend the program to other areas in Togo. The study does not present any risk for participants, as only questionnaires and painless and non-invasive measurements will be taken. There should be no side effects .
Where is the study run from?
The program is set up in 162 villages in five districts of the Kara and Savanes regions, Togo: Dankpen, Keran, Doufelgou, Oti, Kpendjal.
When is study starting and how long is it expected to run for?
The study started in June 2014 and will last 2 years.
Who is funding the study?
1. The World Bank (USA)
2. UNICEF (USA)
3. 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
Dakar
BP206
Senegal
-
mathilde.savy@ird.fr
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Impact evaluation of a cash transfer pilot program in the Kara and Savanes regions, Togo: a randomised controlled trial to determine whether cash transfers during the first 1,000 days from conception though to infancy improve the nutritional status of mothers and young children
Acronym
Study hypothesis
It is hypothesised that the cash transfers during the first 1,000 days (from conception to the child's first 2 years) will optimize growth in utero and during infancy and early childhood.
The null hypothesis is that there will be no difference in nutritional indicators between treatment groups; this may arise if the value of the transfer is insufficient or if the money received is not used properly.
Ethics approval
Comité de Bioéthique pour la Recherche en Santé, Ministère de la Santé, Lomé, Togo [Bioethics Committee for Research in Health, Health Ministry of Lomé, Togo]; 28/03/2014
Study design
Two-year cluster-randomised controlled trial, with repeated cross-sectional surveys (baseline and endline)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Growth retardation
Intervention
1. Group A (control group): women and children attend education sessions
2. Group B (intervention): in addition to education sessions, women receive a cash transfer worth 5000 FCFA (~8 euros) per month over a maximum of 30 months (~1000 days)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Children's stature after 2 years of intervention, expressed in Height-for-Age Z score
Secondary outcome measures
Current secondary outcome measures as of 28/08/2020:
1. Stunting
2. WHZ, wasting
3. Intermediary outcomes:
3.1. Child’s nutrition: IYCF practices (DDS7, MDD, MMF, MAD, iron-rich food), consumption of Animal source food (ASF)
3.2. Mother’s nutrition: MDD-W, DDS 10, number of meals, consumption of ASF
3.2. Household food insecurity: HFIAS (HHS)
3.3. Household food expenditures (as opposed to non-food expenditures)
3.4. Child’s health: morbidity on the previous 15 days, child’s health since birth as perceived by the mother, vaccination, vitamin A supplementation, deworming, regular medical follow-up and age at last medical follow-up, health-seeking behavior (children taken to a health center if sick)
3.5. Maternal health: prenatal and postnatal care (number of consultations, stage of pregnancy at first antenatal visit, TPI malaria, tetanus vaccine, iron supplementation) delivery in health facilities, delivery assisted by a skill birth attendant, birth weight and LBW of newborns
3.6. Child’s hygiene: hands, face, hair and clothes’ cleanliness
3.7. Mother’s hygiene: hands, face, hair and clothes’ cleanliness
3.8. Yard’s hygiene: animal feces, waste
3.9. Mother’s knowledge on nutrition, health and hygiene
3.10. Decision-making power of women
3.11. Intimate partner violence (IPV)
3.12. Child fostering
3.13. Enrollment in school
3.14 Birth registration
Previous secondary outcome measures:
1. Use of preventive healthcare 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 well-being and rights (birth registration, schooling)
5. Knowledge, attitudes and practices towards nutrition, hygiene and health
Overall trial start date
17/05/2014
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children and their mothers willing to participate in the study, living in the villages which have been randomly selected as the treatment or control group. There are two stages to the trial:
1. Cash transfers: Pregnant women and their children up until the child is 24 months old
2. Evaluation: 6-59 month old children and their mothers that have taken part in the trial having received cash transfers and education sessions (treatment group) or as controls (education sessions only)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
4208 child-mother pairs
Participant exclusion criteria
Children and mothers having a mental or physical handicap that could affect growth and well-being.
Recruitment start date
17/05/2014
Recruitment end date
30/06/2016
Locations
Countries of recruitment
Togo
Trial participating centre
IRD
911 av. Agropolis
Montpellier
34394
France
Funders
Funder type
Government
Funder name
The World Bank (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
UNICEF (Togo)
Alternative name(s)
United Nations Children's Emergency Fund
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United States of America
Funder name
Research Institute for Development [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
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository. All data files are available from the Zenodo repository: DOI 10.5281/zenodo.3925899 (https://zenodo.org/record/3925899#.XvzMkufgphG) and no accession number is required for access.
Intention to publish date
31/10/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN83330970_PROTOCOL_01Feb2014.pdf uploaded 04/09/2020