Informational Intervention in Increasing Lactation Practices by African American Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Intervention to Increase Lactation Practices by African American Women

Conditions
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Healthy Subject, Pregnant

Intervention / Treatment
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* Other: Informational Intervention
* Other: Informational Intervention
* Other: Interview
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I: (standard information about pregnancy, breastfeeding)<br>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. | Other: Informational Intervention<br>* Receive standard information about breastfeeding and pregnancy<br>Other: Interview<br>* Participate in focus groups<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Group II (information about breastfeeding and cancer)<br>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. | Other: Informational Intervention<br>* Receive standard information about breastfeeding and pregnancy<br>Other: Informational Intervention<br>* Receive information about breastfeeding and cancer<br>Other: Interview<br>* Participate in focus groups<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 1 year | 
| Behavioral intentions for breastfeeding | Linear regression analyses will be conducted with condition and necessary covariates as predictors. | 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. | 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. | 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. | 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. | Up to 1 year |