Clinical trial NCT03680235: Informational Intervention in Increasing Lactation Practices by African American Women
Official title: Novel Intervention to Increase Lactation Practices by African American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Pregnant
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-21
Enrollment: 296
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial studies how well an informational intervention works in increasing lactation practices by African American women. Giving additional information about breastfeeding and breast cancer risks to African American women may help doctors understand the factors that affect the decision to breast feed and to test whether providing useful information about breastfeeding will change breastfeeding behavior.

Detailed description: PRIMARY OBJECTIVES:

I. Develop appropriate intervention strategies about the "breastfeeding-breast cancer connection" appropriate for use by experienced Women, Infants and Children (WIC) Peer Counselors (PCs) to disseminate to African-American mothers through a community-based participatory research (CBPR) approach including social media..

II. Assess the comparative cognitive (e.g., knowledge, utility, cost-benefit), affective association (e.g., feelings), socioeconomic, familial and intent/outcome (e.g., breastfeeding) measures pre- and post-intervention to determine effectiveness of the content to impact cognitive and feeling measures and increase breastfeeding in young African-American mothers compared to an existing counseling program.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants receive standard information about pregnancy and breastfeeding. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.

GROUP II: Participants receive standard information about pregnancy and breastfeeding as well as information about breastfeeding and breast cancer. Participants may also participate in a focus group with their partner/spouse or family members after the baby's birth.

After completion of the information intervention, participants are followed for up to 1 year.

Eligibility criteria: Inclusion Criteria:

* Pregnant African American women participating in the Catholic Charities WIC Program
* INCLUSION - FOCUS GROUPS: Representative mothers, spouses/partners, influential family members (e.g., grandmothers, sisters) from the families served during the study.
* INCLUSION - FOCUS GROUPS: Partners/spouses may include men or women.

Exclusion Criteria:

* Unwilling or unable to follow protocol requirements.

Primary outcomes:
measure: Breastfeeding rates
timeFrame: Up to 1 year
measure: Behavioral intentions for breastfeeding
timeFrame: Up to 1 year
measure: Perceived risk for breast cancer
timeFrame: Up to 1 year
measure: Affective associations with breastfeeding
timeFrame: Up to 1 year
measure: Perceptions of benefits and barriers to breastfeeding
timeFrame: Up to 1 year
measure: Qualitative analysis of focus group and key informant interviews
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Deborah Erwin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dauphin C, Clark N, Cadzow R, Saad-Harfouche F, Rodriguez E, Glaser K, Kiviniemi M, Keller M, Erwin D. #BlackBreastsMatter: Process Evaluation of Recruitment and Engagement of Pregnant African American Women for a Social Media Intervention Study to Increase Breastfeeding. J Med Internet Res. 2020 Aug 10;22(8):e16239. doi: 10.2196/16239.