Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03455257
Other study ID # 1234
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 21, 2018
Last updated February 27, 2018
Start date April 25, 2017
Est. completion date December 2020

Study information

Verified date February 2018
Source Ministry of Finance, Guinea-Bissau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34148
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Guinea-Bissau PDDC Bissau

Sponsors (4)

Lead Sponsor Collaborator
Ministry of Finance, Guinea-Bissau International Partnership for Human Development (IPHD), National Institute of Statistics (INE), World Bank

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes in family demographics Changes in family demographics will be tracked. Baseline, year 1, year 2 and year 3
Secondary Change in weight 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
Secondary Change in height 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
Secondary Change in mid-upper arm circumference (MUAC) 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
Secondary Change in waist circumference 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
Secondary Change in hemoglobin 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
Secondary Change in blood pressure 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
Secondary Change in HbA1c 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
Secondary Food intake Food intake assessment Year 1, year 2 and year 3
Secondary Cognition function Children born after the cash transfer progam will have a single cognitive function test at 18 months of age. When children are 18th months
Secondary Change in school attendence 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
Secondary Change in head circumference Children born after the cash transfer progam will have head circumference taken. After birth, year 1, year 2, year 3
Secondary Change in Literacy Children 7 and 14 will complete literacy testing. Year 1, year 2, year 3
Secondary Change in Grip Strength 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
See also
  Status Clinical Trial Phase
Completed NCT05594446 - Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
Completed NCT03975309 - DHS MIND Metabolomics
Completed NCT01855399 - Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes N/A
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Recruiting NCT05007990 - Caregiving Networks Across Disease Context and the Life Course
Active, not recruiting NCT04420936 - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program N/A
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Completed NCT04903496 - Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT03390179 - Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Recruiting NCT05294822 - Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes N/A
Completed NCT04427982 - Dance and Diabetes/Prediabetes Self-Management N/A
Completed NCT02356848 - STEP UP to Avert Amputation in Diabetes N/A
Completed NCT03292185 - A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects Phase 1
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4