eHealth for Breastfeeding Support - the HOTSPOT Trial

NCT ID: NCT06378320

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-20

Brief Summary

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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

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Conditions

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Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

App access and Text message

Intervention Type OTHER

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

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.

Group Type OTHER

App access only

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

App access and Text message

Intervention Type OTHER

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

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.

Group Type OTHER

App access only

Intervention Type OTHER

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

Interventions

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App access and Text message

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

Intervention Type OTHER

App access only

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

Intervention Type OTHER

Other Intervention Names

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App access and Text nudge App access

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lydia Furman

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lydia Furman, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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Ahuja Rainbow Center for Women and Children

Cleveland, Ohio, United States

Site Status

Passages, Inc.

Cleveland, Ohio, United States

Site Status

University Hospital MacDonald Women's Hospital

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20240287

Identifier Type: -

Identifier Source: org_study_id

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