eHealth for Breastfeeding Support - the HOTSPOT Trial

University Hospitals (UH)

Status: Completed

Conditions: Breast Feeding

Treatments: Other: App access only; Other: App access and Text message

Study type: Interventional

Funder types: Other

Identifiers

NCT06378320

STUDY20240287

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Maternal participants nudge group

Experimental group

Description:

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.

Treatment:

Other: App access and Text message

Maternal participants no nudge group

Other group

Description:

Participants in the app "no nudge" group receive access to the app and no questions with app cues through 3 months postpartum.

Treatment:

Other: App access only

Father/partner participants nudge group

Experimental group

Description:

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.

Treatment:

Other: App access and Text message

Father/partner participants no nudge group

Other group

Description:

Participants in the app "no nudge" group receive access to the app and no questions with app cues for 4 months.

Treatment:

Other: App access only