BreastfeedingNCT04835051
Alive & Thrive Nigeria Breastfeeding Promotion in Urban Private Facilities Study
A study testing Breastfeeding promotion in people with Breastfeeding, run by RTI International at 20 sites in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 20 sitesNigeria
- Study dates
- 5 Aug 2019to 17 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women ≥18 years old, third trimester
- Current Client of a private health facility
- Infant alive at 6 and 24 weeks postpartum
Who cannot join
- Infant died
- Infant unable to breastfeed
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Nigeria20 sites
Albina Majeed Clinic
Lagos
Ayodele Medical Centre
Lagos
Crystal Specialist
Lagos
Edmac Medical Centre
Lagos
Eko Hospital
Lagos
El-Dunamis Medical Centre
Lagos
Faith City Hospital
Lagos
Fuja Medical Centre
Lagos
Ilogbo Central Hospital
Lagos
Isalu Hospital
Lagos
Matador Hospital
Lagos
Mobonike Hospital
Lagos
Modupeoluwa Mat.Home
Lagos
Promise Medical Centre
Lagos
R-Jolard Hospital
Lagos
Rccg Ebute Metta
Lagos
Rccg Oke Suna
Lagos
Redeemed Maternity Amuwo
Lagos
Regina Mundi Catholic Hospital
Lagos
Uwemdimo Hospital
Lagos
About this study
Official title: Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State
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.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- Breastfeeding promotion
- Keywords
- Exclusive breastfeeding, Early initiation of breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding promotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Breastfeeding promotion |
| Comparison | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
The proportion of infants exclusively breastfed on the previous day
Measured: 6 weeks
Exclusive breastfeeding
The proportion of infants exclusively breastfed on the previous day
Measured: 24 weeks
Secondary outcomes (1)
Early initiation of breastfeeding
The proportion of infants who started breastfeeding within 1 hour of birth
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 Aug 2019
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- FHI 360
- Responsible party
- Sponsor
- Investigators
- Valerie Flax, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835051
- Sponsor's protocol ID
- 20576
- Status last verified
- Jan 2021
- First submitted
- 23 Feb 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared publicly through Harvard Dataverse.
Publications
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.
PubMed 35015869
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research on an Urban Private Sector Model of IYCF Counseling in Private Health Facilities in Lagos State
- ClinicalTrials.gov ID
- NCT04835051
- Acronym / sponsor ID
- 20576
- Conditions
- Breastfeeding
- Keywords
- Exclusive breastfeeding, Early initiation of breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- FHI 360
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding promotion | Other | Behavioral: Breastfeeding promotionThe breastfeeding promotion intervention included training for health workers, interpersonal communication (in person and digital) between providers and pregnant/breastfeeding women, and mass media. |
| Comparison | No intervention | – |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Women ≥18 years old, third trimester
- Current Client of a private health facility
- Infant alive at 6 and 24 weeks postpartum
Key exclusion criteria (2 listed)
- Infant died
- Infant unable to breastfeed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding promotionThe 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. | Behavioural | Breastfeeding promotion |
Primary outcome
Exclusive breastfeeding
Time frame: 6 weeks
The proportion of infants exclusively breastfed on the previous day
Exclusive breastfeeding
Time frame: 24 weeks
The proportion of infants exclusively breastfed on the previous day
1 secondary outcome
Early initiation of breastfeeding
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 35015869Flax 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.
- Individual participant dataSharing planned: Yes. Data will be shared publicly through Harvard Dataverse.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Flax, PhD principal investigator
RTI International
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding promotion in people with Breastfeeding, run by RTI International at 20 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04835051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.