NCT03455257

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34,148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 6, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

February 21, 2018

Last Update Submit

February 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in per capita food expeditures

    change in per capita food expenditure per family will be calculated.

    Baseline, year 1, year 2 and year 3

Secondary Outcomes (14)

  • Changes in family demographics

    Baseline, year 1, year 2 and year 3

  • Change in weight

    Baseline, year 1, year 2 and year 3

  • Change in height

    Baseline, year 1, year 2 and year 3

  • Change in mid-upper arm circumference (MUAC)

    Baseline, year 1, year 2 and year 3

  • Change in waist circumference

    Baseline, year 1, year 2 and year 3

  • +9 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Families assigned to this arm will be assessment only controls that do not receive the cash transfer.

Intervention

EXPERIMENTAL

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

Interventions

Cash TransferBEHAVIORAL

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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PDDC

Bissau, Guinea-Bissau

Location

MeSH Terms

Conditions

AnemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alfa U Jalo, MS

    Ministry of Finance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Clarify randomization and masking
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participating families are randomized into one of two groups, an assessment-only controls group or a cash transfer group.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

March 6, 2018

Study Start

April 25, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 6, 2018

Record last verified: 2018-02

Locations