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临床试验/NCT06375655
NCT06375655已完成不适用

A Proposed Randomized Clinical Trial of the Effectiveness of a New Breastfeeding- Supportive Texting Program Designed Specifically for African-American/Black Expectant Women, as Compared to a National Maternal Health Texting Program, on Rates of Exclusive Breastfeeding at 2 Months

Case Western Reserve University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Number of Participants Who do Not Opt Out of Receipt of Text Messages

研究概览

简要总结

The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Bright By Text), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC.

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
Female
接受健康志愿者
是

入选标准

  • •Expectant women initiating obstetrical care <34 weeks or at any prenatal visit up to 34 weeks gestation
  • •Daily access to a mobile phone with text message capabilities,
  • •Self-identify as African-American/Black,
  • •English speaking, and
  • •Infant feeding plan of "might or will breastfeed"
  • •Receive care at Ahuja Midtown or MAC1200

排除标准

  • •Committed to feeding formula only to their infant
  • •No mobile phone with text capability

研究组 & 干预措施

Team2BF

Experimental

Team2BF includes 3-4 breastfeeding-supportive messages per time interval, sent weekly from 28 weeks gestation through delivery, daily through 2 weeks postpartum, weekly from 2 to 10 weeks, and then monthly to one year. Other maternal health topics are not addressed.

干预措施: Team2BF (Behavioral)

Bright By Text

Active Comparator

Bright By Text sends 2-4 messages per week from the first trimester through and beyond one year postpartum about a wide range of maternal and child health topics as outlined on their website; 8 messages are specifically about breastfeeding.

干预措施: Bright By Text (Behavioral)

结局指标

主要结局

Number of Participants Who do Not Opt Out of Receipt of Text Messages

时间窗: Up to 6 months postpartum

Number of Participants Who Said Texts Were Helpful as Measured by Questionnaire

时间窗: Up to 6 months postpartum

Participants were asked if texts were helpful- yes or no. Reported on number of participants who said yes.

Number of Participants Who Would Refer a Friend/Family to the Texting Program

时间窗: Up to 6 months postpartum

This will be a yes/no answer

次要结局

  • Number of Participants Who Are Exclusively Breastfeeding at 2 Months Postpartum as Measured by Participant Report/Chart Review(Up to 2 months postpartum)
  • Change in the Number of Participants Who Are Exclusively Breastfeeding as Measured by Participant Report/Chart Review(1 month, 3 months, 6 months postpartum)
  • Change in the Number of Participants Who Are Partially Breastfeeding as Measured by Participant Report/Chart Review(1 month, 2 months, 3 months, 6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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