Breast FeedingNCT06378320
eHealth for Breastfeeding Support - the HOTSPOT Trial
A study testing App access and Text message and App access only in people with Breast Feeding, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- App access and Text message and App access only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 May 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Age under 18 years
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ahuja Rainbow Center for Women and Children
Cleveland, Ohio, 44103
Passages, Inc.
Cleveland, Ohio, 44103
University Hospital MacDonald Women's Hospital
Cleveland, Ohio, 44106
About this study
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
- Being tested
- App access and Text message, App access only
- Keywords
- African American, Smartphone app, Milk, Human
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App access and Text messageOther
Also called App access and Text nudge
Access to App and Text messages with app related breastfeeding related question
App access onlyOther
Also called App access
Access to App without Text messages with app related breastfeeding related question
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: App access only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal participants app usability score
Percentage of participants with System Usability Scale score of >78.8
Measured: Up to 3 months postpartum
Father/partner participants app usability score
Percentage of participants with System Usability Scale score of >78.8
Measured: 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
Measured: 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
Measured: Up to 4 months post-enrollment
Secondary outcomes (4)
Maternal participants breastfeeding knowledge at enrollment
Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Measured: At enrollment
Maternal participants breastfeeding knowledge after app exposure
Percentage of participants with 75% or more correct responses to 10 breastfeeding
Measured: At 2 months postpartum
Father/partner participants breastfeeding knowledge at enrollment
Percentage of participants with 75% or more correct responses to 4 breastfeeding knowledge questions
Measured: At enrollment
Father/partner participants breastfeeding knowledge after app exposure
Percentage of participants with 75% or more correct responses to 10 breastfeeding
Measured: At 3 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 May 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Furman, University Hospitals Cleveland Medical Center
- Investigators
- Lydia Furman, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378320
- Sponsor's protocol ID
- STUDY20240287
- Status last verified
- May 2026
- First submitted
- 18 Apr 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eHealth for Breastfeeding Support - the HOTSPOT Trial
- ClinicalTrials.gov ID
- NCT06378320
- Acronym / sponsor ID
- STUDY20240287
- Conditions
- Breast Feeding
- Keywords
- African American, Smartphone app, Milk, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maternal participants nudge group | Experimental | Other: App access and Text messageParticipants 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. |
| Maternal participants no nudge group | Other | Other: App access onlyParticipants in the app "no nudge" group receive access to the app and no questions with app cues through 3 months postpartum. |
| Father/partner participants nudge group | Experimental | Other: App access and Text messageParticipants 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. |
| Father/partner participants no nudge group | Other | Other: App access onlyParticipants in the app "no nudge" group receive access to the app and no questions with app cues for 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App access and Text messageAlso: App access and Text nudgeAccess to App and Text messages with app related breastfeeding related question | Other | Father/partner participants nudge group, Maternal participants nudge group |
| App access onlyAlso: App accessAccess to App without Text messages with app related breastfeeding related question | Other | Father/partner participants no nudge group, Maternal participants no nudge group |
Primary outcome
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
4 secondary outcomes
Maternal participants breastfeeding knowledge at enrollment
Time frame: At enrollment
Maternal participants breastfeeding knowledge after app exposure
Time frame: At 2 months postpartum
Father/partner participants breastfeeding knowledge at enrollment
Time frame: At enrollment
Father/partner participants breastfeeding knowledge after app exposure
Time frame: At 3 months post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Furman, MD principal investigator
University Hospitals Cleveland Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App access and Text message and App access only in people with Breast Feeding, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal participants app usability score (time frame: Up to 3 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.