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Completed

NCT Number: NCT06378320

eHealth for Breastfeeding Support - the HOTSPOT Trial

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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahuja Rainbow Center for Women and Children, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App access and Text message

Other

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

Other names: App access and Text nudge

App access only

Other

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

Other names: App access

Primary outcomes

  1. Maternal participants app usability score

    Time frame: Up to 3 months postpartum

    Percentage of participants with System Usability Scale score of >78.8

  2. Father/partner participants app usability score

    Time frame: Up to 4 months post-enrollment

    Percentage of participants with System Usability Scale score of >78.8

  3. Maternal participants app engagement score

    Time frame: Up to 3 months postpartum

    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

  4. Father/partner participants app engagement score

    Time frame: Up to 4 months post-enrollment

    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

Secondary outcomes

  1. Maternal participants breastfeeding knowledge at enrollment

    Time frame: At enrollment

    Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions

  2. Maternal participants breastfeeding knowledge after app exposure

    Time frame: At 2 months postpartum

    Percentage of participants with 75% or more correct responses to 10 breastfeeding

  3. Father/partner participants breastfeeding knowledge at enrollment

    Time frame: At enrollment

    Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions

  4. Father/partner participants breastfeeding knowledge after app exposure

    Time frame: At 3 months post-enrollment

    Percentage of participants with 75% or more correct responses to 10 breastfeeding

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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