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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding
• Intervention / Treatment: Other: App access and Text message; Other: App access only

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospital MacDonald Women's Hospital
    • Cleveland, Ohio, United States, 44103
      • Ahuja Rainbow Center for Women and Children
    • Cleveland, Ohio, United States, 44103
      • Passages, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal participants nudge group; Participants in the app "nudge" group receive access to the app and questions with app cues by text weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum.	Other: App access and Text message; Access to App and Text messages with app related breastfeeding related question; Other Names: App access and Text nudge
Other: Maternal participants no nudge group; Participants in the app "no nudge" group receive access to the app and no questions with app cues through 3 months postpartum.	Other: App access only; Access to App without Text messages with app related breastfeeding related question; Other Names: App access
Experimental: Father/partner participants nudge group; Participants in the app "nudge" group receive access to the app and questions with app cues by text weekly for the first 2 months and then biweekly (every 2 weeks) for another 2 months.	Other: App access and Text message; Access to App and Text messages with app related breastfeeding related question; Other Names: App access and Text nudge
Other: Father/partner participants no nudge group; Participants in the app "no nudge" group receive access to the app and no questions with app cues for 4 months.	Other: App access only; Access to App without Text messages with app related breastfeeding related question; Other Names: App access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal participants app usability score	Percentage of participants with System Usability Scale score of >78.8	Up to 3 months postpartum
Father/partner participants app usability score	Percentage of participants with System Usability Scale score of >78.8	Up to 4 months post-enrollment
Maternal participants app engagement score	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	Up to 3 months postpartum
Father/partner participants app engagement score	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	Up to 4 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal participants breastfeeding knowledge at enrollment	Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions	At enrollment
Maternal participants breastfeeding knowledge after app exposure	Percentage of participants with 75% or more correct responses to 10 breastfeeding	At 2 months postpartum
Father/partner participants breastfeeding knowledge at enrollment	Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions	At enrollment
Father/partner participants breastfeeding knowledge after app exposure	Percentage of participants with 75% or more correct responses to 10 breastfeeding	At 3 months post-enrollment

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Lydia Furman, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Milk, Human; African American; Smartphone app
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: STUDY20240287

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No