An interventional study of Informational Intervention and Informational Intervention in Healthy Subject and Pregnant, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Health services research
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.
Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Interview · Other: Survey Administration
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 · Other: Interview · Other: Survey Administration
Receive standard information about breastfeeding and pregnancy
Receive information about breastfeeding and cancer
Participate in focus groups
Ancillary studies
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.
Time frame: Up to 1 year
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute