eHealth for Breastfeeding Support - the HOTSPOT Trial
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.
Conditions:
🦠 Breast Feeding
🗓️ Study Start (Actual) 15 March 2024
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 April 2024
  • First Submitted that Met QC Criteria 18 April 2024
  • First Posted 22 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024