Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-22 @ 8:36 PM
Study NCT ID:
NCT04835051
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study
Sponsor:
RTI International
Organization:
Study Overview
Official Title:
Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: