Breastfeeding Education Support Tool for Baby (BEST4Baby)

Thomas Jefferson University

Status: Completed

Conditions: Breastfeeding

Treatments: Other: Breastfeeding counseling and education services

Study type: Interventional

Funder types: Other

Identifiers

NCT03533725

17F.517

Details and patient eligibility

About

This study will compare data associated with breastfeeding experiences and outcomes--specifically, breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration--among 120 subjects recruited late in pregnancy and provided peer counseling and education services incorporating mobile health (mHealth) tools during a period of at least 6 months post-delivery with the data collected from a control group of approximately 120 mothers that did not receive the study intervention.

Full description

Approximately 24 women that are experienced in breastfeeding will be recruited to serve in the role of breastfeeding peer counselors. These women will assess usability and acceptability of mobile health (mHealth) education tools designed following a series of focus groups for the project, Breastfeeding Education Support Tool for Baby. The mHealth tools will be used during the training and education of the peer counselor subjects. Following appropriate modification, some of the mHealth tools will be used with a total of approximately 120 women recruited late in pregnancy for initial breastfeeding counseling before delivery and the subsequent provision, for at least 6 months post-delivery, of home visits for peer counseling and education that integrates use of mHealth tools. Peer counselors and research staff will gather data from mothers receiving the intervention about breastfeeding experiences and outcomes, including breastfeeding continuation after initiation, exclusivity for 6 months of an infant's life, and breastfeeding duration. This data will be compared to data obtained through surveys administered to a control group of approximately 120 maternal subjects that received standard pre- and post-delivery care but not the study intervention of peer counseling and education using mHealth tools.

Enrollment: 247 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

A. Peer counselors

Inclusion Criteria:

Personal experience with breastfeeding - Residence in an intervention cluster

Exclusion Criteria:

• Failing to participate in peer counselor education/training provided for the study

B. Intervention Pregnant women-mothers

Inclusion Criteria:

• Willingness to consent to assignment to a breastfeeding peer counselor and to participate in counseling and education visits
• Residence in an intervention cluster and intent to remain in the intervention area for a minimum of 6 months post-delivery

Exclusion Criteria:

• Pregnant women-mothers that indicate before delivery that they will not initiate breastfeeding

C. Control Subjects

Inclusion Criteria:

• Mothers delivering during the study period that live in a non-intervention area that has been designated for recruitment of control subjects
• Willingness to participate in a survey enabling collection of data for comparative purposes

Exclusion Criteria:

• None

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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247 participants in 2 patient groups

Intervention group

Experimental group

Description:

Breastfeeding counseling and education services using mHealth tools

Treatment:

Other: Breastfeeding counseling and education services

Comparative control group

No Intervention group

Description:

No intervention, only standard of care