eHealth for Breastfeeding Support - the HOTSPOT Trial
- Conditions
- Breast Feeding
- Registration Number
- NCT06378320
- Lead Sponsor
- University Hospitals Cleveland Medical Center
- Brief Summary
This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD.
The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned.
Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Maternal participants
- Adult women who are expecting (pregnant) and between 24-34 weeks gestation
- Self-describe as African-American or Black (AA/B)
- Have a smart phone
- Receive prenatal care at either Ahuja Rainbow Center for Women and Children or MacDonald and Women's Suite 1200 at University Hospitals
- Either interested in or committed to breastfeeding for their infant
- Father/partner participants
- Father (mother/partner is expectant or delivered) or plan to become father
- Age 18 years or older
- Have a smart phone or a personal device or iPad
- Attending programming at Passages, Inc.
- Self-identified interest in how their own infant will be fed
- Self-describe as African-American or Black
- Age under 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maternal participants app usability score Up to 3 months postpartum Percentage of participants with System Usability Scale score of \>78.8
Father/partner participants app usability score Up to 4 months post-enrollment Percentage of participants with System Usability Scale score of \>78.8
Maternal participants app engagement score Up to 3 months postpartum Percentage of participants with an app interaction score of more than 1 on a 5 point scale with 1 meaning no engagement past week and 5 meaning more than daily engagement in the past week
Father/partner participants app engagement score Up to 4 months post-enrollment Percentage of participants with an app interaction score of more than 1 on a 5 point scale with 1 meaning no engagement past week and 5 meaning more than daily engagement in the past week
- Secondary Outcome Measures
Name Time Method Maternal participants breastfeeding knowledge at enrollment At enrollment Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Father/partner participants breastfeeding knowledge at enrollment At enrollment Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Father/partner participants breastfeeding knowledge after app exposure At 3 months post-enrollment Percentage of participants with 75% or more correct responses to 10 breastfeeding
Maternal participants breastfeeding knowledge after app exposure At 2 months postpartum Percentage of participants with 75% or more correct responses to 10 breastfeeding
Trial Locations
- Locations (3)
Ahuja Rainbow Center for Women and Children
🇺🇸Cleveland, Ohio, United States
Passages, Inc.
🇺🇸Cleveland, Ohio, United States
University Hospital MacDonald Women's Hospital
🇺🇸Cleveland, Ohio, United States
Ahuja Rainbow Center for Women and Children🇺🇸Cleveland, Ohio, United States