Informational Intervention in Increasing Lactation Practices by African American Women

NCT ID: NCT03680235

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subject Pregnant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I: (standard information about pregnancy, breastfeeding)

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 Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive standard information about breastfeeding and pregnancy

Interview

Intervention Type OTHER

Participate in focus groups

Survey Administration

Intervention Type OTHER

Ancillary studies

Group II (information about breastfeeding and cancer)

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.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive standard information about breastfeeding and pregnancy

Informational Intervention

Intervention Type OTHER

Receive information about breastfeeding and cancer

Interview

Intervention Type OTHER

Participate in focus groups

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Informational Intervention

Receive standard information about breastfeeding and pregnancy

Intervention Type OTHER

Informational Intervention

Receive information about breastfeeding and cancer

Intervention Type OTHER

Interview

Participate in focus groups

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah Erwin

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32773377 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2018-00854

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 270615

Identifier Type: OTHER

Identifier Source: secondary_id

R21CA202263

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 270615

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.