protocolSection identificationModule nctId: NCT06378320, orgStudyIdInfo id: STUDY20240287, briefTitle: eHealth for Breastfeeding Support - the HOTSPOT Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospitals Cleveland Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Breast Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: App access and Text message, interventions name: App access only, outcomesModule primaryOutcomes measure: Maternal participants app usability score, primaryOutcomes measure: Father/partner participants app usability score, primaryOutcomes measure: Maternal participants app engagement score, primaryOutcomes measure: Father/partner participants app engagement score, secondaryOutcomes measure: Maternal participants breastfeeding knowledge at enrollment, secondaryOutcomes measure: Maternal participants breastfeeding knowledge after app exposure, secondaryOutcomes measure: Father/partner participants breastfeeding knowledge at enrollment, secondaryOutcomes measure: Father/partner participants breastfeeding knowledge after app exposure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ahuja Rainbow Center for Women and Children, city: Cleveland, state: Ohio, zip: 44103, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Passages, Inc., city: Cleveland, state: Ohio, zip: 44103, country: United States, contacts name: Lydia Furman MD, role: CONTACT, phone: 216-675-6691, email: lydia.furman@uhhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, locations facility: University Hospital MacDonald Women's Hospital, city: Cleveland, state: Ohio, zip: 44106, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False