eHealth for Breastfeeding Support - the HOTSPOT Trial

NCT06378320 | Completed

• 1 other identifier: STUDY20240287
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Feeding

Keywords

African American; Smartphone app; Milk, Human

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Maternal participants breastfeeding knowledge at enrollment

  At enrollment

• Maternal participants breastfeeding knowledge after app exposure

  At 2 months postpartum

• Father/partner participants breastfeeding knowledge at enrollment

  At enrollment

• Father/partner participants breastfeeding knowledge after app exposure

  At 3 months post-enrollment

Study Arms (4)

Maternal participants nudge group

EXPERIMENTAL

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

Maternal participants no nudge group

OTHER

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

Father/partner participants nudge group

EXPERIMENTAL

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

Father/partner participants no nudge group

OTHER

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

Interventions

App access and Text message OTHER

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

Also known as: App access and Text nudge

Father/partner participants nudge group; Maternal participants nudge group

App access only OTHER

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

Also known as: App access

Father/partner participants no nudge group; Maternal participants no nudge group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Potential participants may enroll as expectant women or as a father/partner. Gender is self-identified.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (3)

Ahuja Rainbow Center for Women and Children

Cleveland, Ohio, 44103, United States

Location

Passages, Inc.

Cleveland, Ohio, 44103, United States

Location

University Hospital MacDonald Women's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Lydia Furman, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 22, 2024
• Study Start: March 15, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)