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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.


Recruitment information / eligibility

Status Completed
Enrollment 1220
Est. completion date July 17, 2020
Est. primary completion date July 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Breastfeeding promotion
The intervention included training of health workers in private health facilities to provide in-person breastfeeding counseling to pregnant women and women with a child <6 months during clinic visits. The health workers also offered a mobile phone support component for appointment reminders, breastfeeding SMS and WhatsApp messages, WhatsApp breastfeeding support groups, informational materials (posters and foldable pocket-sized cards), and family engagement activities. Breastfeeding-related mass media through television and radio spots was available state-wide, including to women in intervention and comparison facilities.

Locations

Country Name City State
Nigeria Albina Majeed Clinic Lagos
Nigeria Ayodele Medical Centre Lagos
Nigeria Crystal Specialist Lagos
Nigeria Edmac Medical Centre Lagos
Nigeria Eko Hospital Lagos
Nigeria El-Dunamis Medical Centre Lagos
Nigeria Faith City Hospital Lagos
Nigeria Fuja Medical Centre Lagos
Nigeria Ilogbo Central Hospital Lagos
Nigeria Isalu Hospital Lagos
Nigeria Matador Hospital Lagos
Nigeria Mobonike Hospital Lagos
Nigeria Modupeoluwa Mat.Home Lagos
Nigeria Promise Medical Centre Lagos
Nigeria R-Jolard Hospital Lagos
Nigeria Rccg Ebute Metta Lagos
Nigeria Rccg Oke Suna Lagos
Nigeria Redeemed Maternity Amuwo Lagos
Nigeria Regina Mundi Catholic Hospital Lagos
Nigeria Uwemdimo Hospital Lagos

Sponsors (2)

Lead Sponsor Collaborator
RTI International FHI 360

Country where clinical trial is conducted

Nigeria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding The proportion of infants exclusively breastfed on the previous day 6 weeks
Primary Exclusive breastfeeding The proportion of infants exclusively breastfed on the previous day 24 weeks
Secondary Early initiation of breastfeeding The proportion of infants who started breastfeeding within 1 hour of birth At birth
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