Informational Intervention in Increasing Lactation Practices by African American Women

Roswell Park Cancer Institute296 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

296

Conditions

Healthy Subject Pregnant

Interventions

Informational InterventionOTHER

Receive standard information about breastfeeding and pregnancy

Informational InterventionOTHER

Receive information about breastfeeding and cancer

InterviewOTHER

Participate in focus groups

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

Breastfeeding rates

Will be assessed by estimating a logistic regression model with breastfeeding as the dichotomous outcome variable and intervention condition as a predictor variable.

Time frame: Up to 1 year

Behavioral intentions for breastfeeding

Linear regression analyses will be conducted with condition and necessary covariates as predictors.

Time frame: Up to 1 year

Perceived risk for breast cancer

Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceived risk for breast cancer mediate any intervention impact on breastfeeding behavior and behavioral intentions.

Time frame: Up to 1 year

Affective associations with breastfeeding

Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which affective associations with breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.

Time frame: Up to 1 year

Perceptions of benefits and barriers to breastfeeding

Linear regression analyses will be conducted with condition and necessary covariates as predictors. Will examine the degree to which perceptions of benefits and barriers to breastfeeding mediate any intervention impact on breastfeeding behavior and behavioral intentions.

Time frame: Up to 1 year

Qualitative analysis of focus group and key informant interviews

Will be recorded and transcribed. This text will be coded and categorized by Erwin following methods established in earlier research. The PEN-3 Model analysis will focus on the most salient factors as they apply to what will be considered the ?Positive, Existential, Negative? influences within the Cultural Empowerment domain in reference to breastfeeding and formula feeding topics. Will sort the responses into categories in a 3 x 3 table according to the Relationships and Expectations domain factors, ?Perceptions, Enablers, Nurturers,? on one axis, and the ?Positive, Existential, Negative? factors across the other axis. This categorical analysis will be reviewed and edited and the Women, Infants and Children (WIC) peer counselors (PCs) to increase validity of the process.

Data from ClinicalTrials.gov

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