Breastfeeding Education Support Tool for Baby
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 247
- Locations
- 2
- Primary Endpoint
- Breastfeeding initiation soon after birth
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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:
Outcomes
Primary Outcomes
Breastfeeding initiation soon after birth
Time Frame: Ideally within an hour following a normal delivery
Maternal subjects' compliance with the recommendation to initiate breastfeeding soon after delivery
Exclusivity of breastfeeding during the first 6 months following an infant's birth
Time Frame: First 6 months following an infant's birth
Maternal subjects' compliance with the recommendation to provide only breast milk
Breastfeeding continuation (along with supplemental feeding) after an infant reaches 6 months of age
Time Frame: As the study is time-limited, assessment will occur 6-9 months following an infant's birth
Maternal subjects' compliance with the recommendation for continued breastfeeding along with supplemental feeding after an infant reaches 6 months of age
Secondary Outcomes
- Usability rating of the mHealth tools by peer counselors post-training(At the end of counseling education/training (project months 8-9))
- Usability rating of the mHealth tools by peer counselors based on use with mothers(Once peer counselors complete delivery of services to assigned maternal subjects (by months 22-23 of the project))
- Acceptability rating of BEST4Baby program features by mothers(3 months post-delivery)
- Satisfaction rating of mothers with BEST4Baby counseling and education services as delivered(6-9 months post-delivery)