Informational Intervention in Increasing Lactation Practices by African American Women

NCT03680235 | Completed DMC

• 3 other identifiers: I 270615NCI-2018-00854R21CA202263
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject; Pregnant

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group I: (standard information about pregnancy, breastfeeding)

ACTIVE COMPARATOR

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

Group II (information about breastfeeding and cancer)

EXPERIMENTAL

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

Interventions

Informational Intervention OTHER

Receive standard information about breastfeeding and pregnancy

Group I: (standard information about pregnancy, breastfeeding); Group II (information about breastfeeding and cancer)

Interview OTHER

Participate in focus groups

Group I: (standard information about pregnancy, breastfeeding); Group II (information about breastfeeding and cancer)

Survey Administration OTHER

Ancillary studies

Group I: (standard information about pregnancy, breastfeeding); Group II (information about breastfeeding and cancer)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant African American women participating in the Catholic Charities WIC Program

You may not qualify if:

• Unwilling or unable to follow protocol requirements.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• 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.

  PMID: 32773377 DERIVED

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Deborah Erwin

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: July 11, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

US (1)