Evaluation of a Cash Transfer Program in Low-Income Families in Guinea-Bissau

February 27, 2018 updated by: Ministry of Finance, Guinea-Bissau
This pilot study will test the effect of a cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cash transfer (CT) programs in low-income countries that allow recipients to receive cash designated for specific household expenditures such as food and family health and education typically show significant program benefits. In particular, several programs have shown positive impacts on use of health care resources, nutrition status and self-reported health, along with significant improvements in the motor and cognitive development of young children.

Guinea-Bissau is currently the 11th poorest country and is thus an appropriate target for a cash transfer program. This project will pilot test the effect of a 2 year cash transfer program aiming to improve family food consumption patterns, family health and schooling, with resulting benefits for childhood growth and cognition. Family-wide assessment will be conducted to examine the impact in all family members. Baseline and 3 follow up assessments will be completed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Families (defined as groups of individuals who routinely eat together) in 3 regions of Guinea-Bissau.
  • Identified by developing scale based upon household characteristics and assets per capita. As well as access to services such as water, electricity and sanitation.
  • Families having the lowest score identified as lowest income were recruited.

Exclusion Criteria:

  • Families with high scores on asset scale.
  • Families uninterested in participating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Families assigned to this arm will be assessment only controls that do not receive the cash transfer.
Experimental: Intervention
Families assigned to this arm will recieve a cash transfer following an in-depth conversation with the head of household and the signing of a contract stating they understand the purpose of the study.
Behavioral: Cash Transfer
The heads of households will receive a cash transfer for up to 7 family members in the home every quarter. Head of households will be expected to attend meetings every 4 months at their local community health centers led by Community Health Workers (CHW). Meetings will have 2 components: 1) children under 5 will be measured to identify children at risk of malnutrition and 2) group education sessions. There will also be monthly growth monitoring and education sessions led by CHW for a subgroup of head of households with children identified as risk of malnutrition with rapid referrals to regional tertiary clinics for any children with health problems that cannot be addressed by CHW.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in per capita food expeditures
Time Frame: Baseline, year 1, year 2 and year 3
change in per capita food expenditure per family will be calculated.
Baseline, year 1, year 2 and year 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in family demographics
Time Frame: Baseline, year 1, year 2 and year 3
Changes in family demographics will be tracked.
Baseline, year 1, year 2 and year 3
Change in weight
Time Frame: Baseline, year 1, year 2 and year 3
Change in weight for all participants in the study and children born after cash transfer program starts.
Baseline, year 1, year 2 and year 3
Change in height
Time Frame: Baseline, year 1, year 2 and year 3
Change in height for all participants in the study and children born after cash transfer program starts.
Baseline, year 1, year 2 and year 3
Change in mid-upper arm circumference (MUAC)
Time Frame: Baseline, year 1, year 2 and year 3
Change in MUAC for all participants in the study and children born after cash transfer program starts.
Baseline, year 1, year 2 and year 3
Change in waist circumference
Time Frame: Baseline, year 1, year 2 and year 3
Change in waist circumference for all participants in the study and children born after cash transfer program starts.
Baseline, year 1, year 2 and year 3
Change in hemoglobin
Time Frame: Baseline, year 1, year 2 and year 3
Change in hemoglobin for pregnant women, children born after the program begins, older children born in 2003, 2010, 2014.
Baseline, year 1, year 2 and year 3
Change in blood pressure
Time Frame: Baseline, year 1, year 2 and year 3
Change in blood pressure will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Baseline, year 1, year 2 and year 3
Change in HbA1c
Time Frame: Baseline, year 1, year 2 and year 3
Change in HbA1c will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Baseline, year 1, year 2 and year 3
Food intake
Time Frame: Year 1, year 2 and year 3
Food intake assessment
Year 1, year 2 and year 3
Cognition function
Time Frame: When children are 18th months
Children born after the cash transfer progam will have a single cognitive function test at 18 months of age.
When children are 18th months
Change in school attendence
Time Frame: Each semester of school in year 1, 2 and 3 of study
School enrollment, attendance, drop out and grade graduation will be assessed for all children through data extraction from school records.
Each semester of school in year 1, 2 and 3 of study
Change in head circumference
Time Frame: After birth, year 1, year 2, year 3
Children born after the cash transfer progam will have head circumference taken.
After birth, year 1, year 2, year 3
Change in Literacy
Time Frame: Year 1, year 2, year 3
Children 7 and 14 will complete literacy testing.
Year 1, year 2, year 3
Change in Grip Strength
Time Frame: Baseline, year 1, year 2 and year 3
Change in grip strength will be measured in 100 randomly selected families in each region with a family size 2-4 and 5-8.
Baseline, year 1, year 2 and year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ministry of Finance, Guinea-Bissau

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Bank
International Partnership for Human Development (IPHD)
National Institute of Statistics (INE)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alfa U Jalo, MS, Ministry of Finance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1234 (Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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