Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study

NCT ID: NCT04835051

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-07-17

Brief Summary

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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

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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.

Conditions

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Breastfeeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Breastfeeding promotion

The breastfeeding promotion intervention included training for health workers, interpersonal communication (in person and digital) between providers and pregnant/breastfeeding women, and mass media.

Group Type OTHER

Breastfeeding promotion

Intervention Type BEHAVIORAL

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.

Comparison

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FHI 360

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Flax, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

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Albina Majeed Clinic

Lagos, , Nigeria

Site Status

Ayodele Medical Centre

Lagos, , Nigeria

Site Status

Crystal Specialist

Lagos, , Nigeria

Site Status

Edmac Medical Centre

Lagos, , Nigeria

Site Status

Eko Hospital

Lagos, , Nigeria

Site Status

El-Dunamis Medical Centre

Lagos, , Nigeria

Site Status

Faith City Hospital

Lagos, , Nigeria

Site Status

Fuja Medical Centre

Lagos, , Nigeria

Site Status

Ilogbo Central Hospital

Lagos, , Nigeria

Site Status

Isalu Hospital

Lagos, , Nigeria

Site Status

Matador Hospital

Lagos, , Nigeria

Site Status

Mobonike Hospital

Lagos, , Nigeria

Site Status

Modupeoluwa Mat.Home

Lagos, , Nigeria

Site Status

Promise Medical Centre

Lagos, , Nigeria

Site Status

R-Jolard Hospital

Lagos, , Nigeria

Site Status

Rccg Ebute Metta

Lagos, , Nigeria

Site Status

Rccg Oke Suna

Lagos, , Nigeria

Site Status

Redeemed Maternity Amuwo

Lagos, , Nigeria

Site Status

Regina Mundi Catholic Hospital

Lagos, , Nigeria

Site Status

Uwemdimo Hospital

Lagos, , Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type DERIVED
PMID: 35015869 (View on PubMed)

Other Identifiers

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20576

Identifier Type: -

Identifier Source: org_study_id

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