eHealth for Breastfeeding Support - the HOTSPOT Trial

Breast Feeding Clinical Trial

Official title:

eHealth for Breastfeeding Support - the HOTSPOT Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378320
• Other study ID #: STUDY20240287
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Lydia Furman
• Phone: 216-675-6691
• Email: lydia.furman[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Other:
• App access and Text message
Access to App and Text messages with app related breastfeeding related question
• App access only
Access to App without Text messages with app related breastfeeding related question

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal participants app usability score	Percentage of participants with System Usability Scale score of >78.8	Up to 3 months postpartum
Primary	Father/partner participants app usability score	Percentage of participants with System Usability Scale score of >78.8	Up to 4 months post-enrollment
Primary	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
Primary	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	Maternal participants breastfeeding knowledge at enrollment	Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions	At enrollment
Secondary	Maternal participants breastfeeding knowledge after app exposure	Percentage of participants with 75% or more correct responses to 10 breastfeeding	At 2 months postpartum
Secondary	Father/partner participants breastfeeding knowledge at enrollment	Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions	At enrollment
Secondary	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