eHealth for Breastfeeding Support - the HOTSPOT Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Maternal participants app usability score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Age under 18 years
研究组 & 干预措施
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.
干预措施: App access and Text message (Other)
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.
干预措施: App access only (Other)
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.
干预措施: App access and Text message (Other)
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.
干预措施: App access only (Other)
结局指标
主要结局
Maternal participants app usability score
时间窗: Up to 3 months postpartum
Percentage of participants with System Usability Scale score of \>78.8
Father/partner participants app usability score
时间窗: Up to 4 months post-enrollment
Percentage of participants with System Usability Scale score of \>78.8
Maternal participants app engagement score
时间窗: 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
时间窗: 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
次要结局
- Maternal participants breastfeeding knowledge at enrollment(At enrollment)
- Father/partner participants breastfeeding knowledge at enrollment(At enrollment)
- Father/partner participants breastfeeding knowledge after app exposure(At 3 months post-enrollment)
- Maternal participants breastfeeding knowledge after app exposure(At 2 months postpartum)
研究者
Lydia Furman
Attending Physician
University Hospitals Cleveland Medical Center