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eHealth for Breastfeeding Support - the HOTSPOT Trial

eHealth for Breastfeeding Support - the HOTSPOT Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06378320
Enrollment
20
Registered
2024-04-22
Start date
2024-05-15
Completion date
2024-12-20
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding

Keywords

African American, Smartphone app, Milk, Human

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.

Interventions

OTHERApp access and Text message

Access to App and Text messages with app related breastfeeding related question

OTHERApp access only

Access to App without Text messages with app related breastfeeding related question

Sponsors

University Hospitals Cleveland Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

This will be a prospective randomized two arm study for expectant women and a prospective randomized two arm study for fathers/partners. All participants receive access to the wireframe app. Maternal participants will be randomized to nudge or no nudge via text with those in the app "nudge" group receiving questions weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum. The purpose of these "nudges" is to assess whether participants are more likely to access and benefit from the app if they are encouraged to explore it. Father/partner participants will also be randomized to either a nudge or no nudge group with those in the "nudge" group receiving questions weekly for the first two months and then biweekly (every 2 weeks) for another two months.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal participants app usability scoreUp to 3 months postpartumPercentage of participants with System Usability Scale score of \>78.8
Father/partner participants app usability scoreUp to 4 months post-enrollmentPercentage of participants with System Usability Scale score of \>78.8
Maternal participants app engagement scoreUp to 3 months postpartumPercentage 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 scoreUp to 4 months post-enrollmentPercentage 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

MeasureTime frameDescription
Maternal participants breastfeeding knowledge at enrollmentAt enrollmentPercentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Maternal participants breastfeeding knowledge after app exposureAt 2 months postpartumPercentage of participants with 75% or more correct responses to 10 breastfeeding
Father/partner participants breastfeeding knowledge at enrollmentAt enrollmentPercentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Father/partner participants breastfeeding knowledge after app exposureAt 3 months post-enrollmentPercentage of participants with 75% or more correct responses to 10 breastfeeding

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLydia Furman, MD

University Hospitals Cleveland Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026