Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04835051 |
| Other study ID # |
20576 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 5, 2019 |
| Est. completion date |
July 17, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
RTI International |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study was to evaluate the effect of a breastfeeding promotion
intervention on breastfeeding intentions, early initiation of breastfeeding, and exclusive
breastfeeding among clients in private health facilities in Lagos, Nigeria.
Description:
This was a longitudinal cohort study designed to evaluate and measure the implementation
processes of a breastfeeding counseling and support intervention offered to pregnant and
postpartum women in private health facilities in Lagos State, Nigeria. This study was
conducted as part of the Alive & Thrive Nigeria program, implemented by FHI 360 and partners.
RTI led the design, implementation, and analysis for the study, with Datametrics Associates
Ltd. serving as the data collection partner in Nigeria. The study took place in 20 private
health facilities. Ten facilities were assigned to intervention and 10 to comparison based on
their location within the existing intervention and comparison local government areas (LGAs)
for our overall impact evaluation of the Alive & Thrive program in Nigeria (NCT02975063). To
be included in the study, facilities had to provide maternity and pediatric services, such as
antenatal care, postnatal care, and immunizations, and be registered with the Association of
General and Private Medical Practitioners of Nigeria and the Health Facility Monitoring and
Accreditation Agency. To ensure that the investigators would achieve their sample size,
selected facilities with a monthly average of ≥40 antenatal clients and ≥20 deliveries over 3
months. All eligible women attending antenatal care on the days of data collection were
invited to participate until the target enrollment at each facility was achieved. The
investigators collected survey data from a cohort of 1,200 women (600 per study arm) during
the third trimester of pregnancy and when their child was 6 weeks and 24 weeks. The purpose
of the surveys were to obtain data on the women's breastfeeding intentions (third trimester)
and practices (6 weeks and 24 weeks), their breastfeeding knowledge and attitudes, and their
exposure to the intervention. To measure implementation outcomes, the investigators conducted
180 observations of client-provider interactions among a subset of women enrolled in the
study and then completed a short exit interview with the women immediately after their
facility visit. In addition, the investigators conducted qualitative interviews with 20
health providers and facility managers/owners in the intervention facilities at the end of
the intervention to learn about the facilitators and barriers to implementation.
