NCT04835051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

February 23, 2021

Last Update Submit

April 6, 2021

Conditions

Keywords

Exclusive breastfeedingEarly initiation of breastfeeding

Outcome Measures

Primary Outcomes (2)

  • Exclusive breastfeeding

    The proportion of infants exclusively breastfed on the previous day

    6 weeks

  • Exclusive breastfeeding

    The proportion of infants exclusively breastfed on the previous day

    24 weeks

Secondary Outcomes (1)

  • Early initiation of breastfeeding

    At birth

Study Arms (2)

Breastfeeding promotion

OTHER

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

Behavioral: Breastfeeding promotion

Comparison

NO INTERVENTION

Interventions

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.

Breastfeeding promotion

Eligibility Criteria

Age15 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Infant died
  • Infant unable to breastfeed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Albina Majeed Clinic

Lagos, Nigeria

Location

Ayodele Medical Centre

Lagos, Nigeria

Location

Crystal Specialist

Lagos, Nigeria

Location

Edmac Medical Centre

Lagos, Nigeria

Location

Eko Hospital

Lagos, Nigeria

Location

El-Dunamis Medical Centre

Lagos, Nigeria

Location

Faith City Hospital

Lagos, Nigeria

Location

Fuja Medical Centre

Lagos, Nigeria

Location

Ilogbo Central Hospital

Lagos, Nigeria

Location

Isalu Hospital

Lagos, Nigeria

Location

Matador Hospital

Lagos, Nigeria

Location

Mobonike Hospital

Lagos, Nigeria

Location

Modupeoluwa Mat.Home

Lagos, Nigeria

Location

Promise Medical Centre

Lagos, Nigeria

Location

R-Jolard Hospital

Lagos, Nigeria

Location

Rccg Ebute Metta

Lagos, Nigeria

Location

Rccg Oke Suna

Lagos, Nigeria

Location

Redeemed Maternity Amuwo

Lagos, Nigeria

Location

Regina Mundi Catholic Hospital

Lagos, Nigeria

Location

Uwemdimo Hospital

Lagos, Nigeria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Valerie Flax, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

April 8, 2021

Study Start

August 5, 2019

Primary Completion

July 17, 2020

Study Completion

July 17, 2020

Last Updated

April 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Data will be shared publicly through Harvard Dataverse.

Time Frame
January 31, 2022
Access Criteria
open

Locations