Clinical trial NCT04835051: Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study
Official title: Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Exclusive breastfeeding
Early initiation of breastfeeding
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: FHI 360
First posted: 2021-04-08
Enrollment: 1220
Sex: ALL
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion:

* Women ≥18 years old, third trimester
* Current Client of a private health facility
* Infant alive at 6 and 24 weeks postpartum

Exclusion:

* Infant died
* Infant unable to breastfeed

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: 6 weeks
measure: Exclusive breastfeeding
timeFrame: 24 weeks
Secondary outcomes:
measure: Early initiation of breastfeeding
timeFrame: At birth
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Albina Majeed Clinic
city: Lagos
country: Nigeria
facility: Ayodele Medical Centre
city: Lagos
country: Nigeria
facility: Crystal Specialist
city: Lagos
country: Nigeria
facility: Edmac Medical Centre
city: Lagos
country: Nigeria
facility: Eko Hospital
city: Lagos
country: Nigeria
facility: El-Dunamis Medical Centre
city: Lagos
country: Nigeria
facility: Faith City Hospital
city: Lagos
country: Nigeria
facility: Fuja Medical Centre
city: Lagos
country: Nigeria
facility: Ilogbo Central Hospital
city: Lagos
country: Nigeria
facility: Isalu Hospital
city: Lagos
country: Nigeria
facility: Matador Hospital
city: Lagos
country: Nigeria
facility: Mobonike Hospital
city: Lagos
country: Nigeria
facility: Modupeoluwa Mat.Home
city: Lagos
country: Nigeria
facility: Promise Medical Centre
city: Lagos
country: Nigeria
facility: R-Jolard Hospital
city: Lagos
country: Nigeria
facility: Rccg Ebute Metta
city: Lagos
country: Nigeria
facility: Rccg Oke Suna
city: Lagos
country: Nigeria
facility: Redeemed Maternity Amuwo
city: Lagos
country: Nigeria
facility: Regina Mundi Catholic Hospital
city: Lagos
country: Nigeria
facility: Uwemdimo Hospital
Study officials:
affiliation: RTI International
name: Valerie Flax, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flax VL, Ipadeola A, Schnefke CH, Ralph-Opara U, Adeola O, Edwards S, Bose S, Brower AO. Breastfeeding Interpersonal Communication, Mobile Phone Support, and Mass Media Messaging Increase Exclusive Breastfeeding at 6 and 24 Weeks Among Clients of Private Health Facilities in Lagos, Nigeria. J Nutr. 2022 May 5;152(5):1316-1326. doi: 10.1093/jn/nxab450.