Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2014
Date assigned
09/09/2014
Last edited
09/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 child’s 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 children’s well-being and social protection. Our aim is to see if the giving cash to women have an impact on children’s 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 child’s 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

ClinicalTrials.gov number

Protocol/serial number

N/A

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 measures

Children’s stature after 2 years of intervention, expressed in Height-for-Age Z score

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

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-LARTES
Dakar
BP206
Senegal

Sponsor information

Organisation

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

Sponsor details

Immeuble Le Sextant
CS 90009
44 Boulevard Dunkerque
Marseille
13572
France

Sponsor type

Research organisation

Website

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

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

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