eHealth for Breastfeeding Support - the HOTSPOT Trial (NCT06378320) | Clinical Trial Compass
CompletedNot Applicable
eHealth for Breastfeeding Support - the HOTSPOT Trial
United States20 participantsStarted 2024-05-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Age under 18 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal participants app usability score
Timeframe: Up to 3 months postpartum
2
Father/partner participants app usability score
Timeframe: Up to 4 months post-enrollment
3
Maternal participants app engagement score
Timeframe: Up to 3 months postpartum
4
Father/partner participants app engagement score
Timeframe: Up to 4 months post-enrollment
Trial details
NCT IDNCT06378320
SponsorUniversity Hospitals Cleveland Medical Center