Informational Intervention in Increasing Lactation Practices by African American Women

Roswell Park Comprehensive Cancer Center

Status: Completed

Conditions: Healthy Subject; Pregnant

Treatments: Other: Interview; Other: Survey Administration; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03680235

I 270615 (Other Identifier)

R21CA202263 (U.S. NIH Grant/Contract)

NCI-2018-00854 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 296 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Group I: (standard information about pregnancy, breastfeeding)

Active Comparator group

Description:

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.

Treatment:

Other: Interview

Other: Survey Administration

Other: Informational Intervention

Other: Informational Intervention

Group II (information about breastfeeding and cancer)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Survey Administration

Other: Informational Intervention

Other: Informational Intervention