Clinical trial NCT06378320: eHealth for Breastfeeding Support - the HOTSPOT Trial
Official title: eHealth for Breastfeeding Support - the HOTSPOT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: African American
Smartphone app
Milk, Human
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal participants app usability score
timeFrame: Up to 3 months postpartum
measure: Father/partner participants app usability score
timeFrame: Up to 4 months post-enrollment
measure: Maternal participants app engagement score
timeFrame: Up to 3 months postpartum
measure: Father/partner participants app engagement score
timeFrame: Up to 4 months post-enrollment
Secondary outcomes:
measure: Maternal participants breastfeeding knowledge at enrollment
timeFrame: At enrollment
measure: Maternal participants breastfeeding knowledge after app exposure
timeFrame: At 2 months postpartum
measure: Father/partner participants breastfeeding knowledge at enrollment
timeFrame: At enrollment
measure: Father/partner participants breastfeeding knowledge after app exposure
timeFrame: At 3 months post-enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ahuja Rainbow Center for Women and Children
state: Ohio
city: Cleveland
country: United States
facility: Passages, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospital MacDonald Women's Hospital
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lydia Furman, MD
role: PRINCIPAL_INVESTIGATOR
References: