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Clinical Trials/NCT03533725
NCT03533725
Completed
N/A

Breastfeeding Education Support Tool for Baby

Thomas Jefferson University1 site in 1 country247 target enrollmentMarch 11, 2019
ConditionsBreastfeeding

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
Thomas Jefferson University
Enrollment
247
Locations
1
Primary Endpoint
Breastfeeding initiation soon after birth
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2019
End Date
June 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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