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eHealth for Breastfeeding Support - the HOTSPOT Trial

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ClinicalTrials.gov Identifier: NCT06378320
Recruitment Status : Not yet recruiting
First Posted : April 22, 2024
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Lydia Furman, University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE April 18, 2024
First Posted Date  ICMJE April 22, 2024
Last Update Posted Date April 22, 2024
Estimated Study Start Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2024)
  • Maternal participants app usability score [ Time Frame: Up to 3 months postpartum ]
    Percentage of participants with System Usability Scale score of >78.8
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2024)
  • Maternal participants breastfeeding knowledge at enrollment [ Time Frame: At enrollment ]
    Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eHealth for Breastfeeding Support - the HOTSPOT Trial
Official Title  ICMJE eHealth for Breastfeeding Support - the HOTSPOT Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Feeding
Intervention  ICMJE
  • Other: App access and Text message
    Access to App and Text messages with app related breastfeeding related question
    Other Name: App access and Text nudge
  • Other: App access only
    Access to App without Text messages with app related breastfeeding related question
    Other Name: App access
Study Arms  ICMJE
  • Experimental: Maternal participants nudge group
    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.
    Intervention: Other: App access and Text message
  • Maternal participants no nudge group
    Participants in the app "no nudge" group receive access to the app and no questions with app cues through 3 months postpartum.
    Intervention: Other: App access only
  • Experimental: Father/partner participants nudge group
    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.
    Intervention: Other: App access and Text message
  • Father/partner participants no nudge group
    Participants in the app "no nudge" group receive access to the app and no questions with app cues for 4 months.
    Intervention: Other: App access only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2024)		 24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2025
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Potential participants may enroll as expectant women or as a father/partner. Gender is self-identified.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lydia Furman 216-675-6691 lydia.furman@uhhospitals.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06378320
Other Study ID Numbers  ICMJE STUDY20240287
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lydia Furman, University Hospitals Cleveland Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP