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临床试验/NCT04108533
NCT04108533已完成不适用

LATcH: Lactation Achievement With Texts at Home

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年1月6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
124
试验地点
1
主要终点
Exclusivity

研究概览

简要总结

The objective of this study is to determine if text-based breastfeeding support improves breastfeeding initiation, exclusivity, and duration when compared to usual postpartum care. All women without a contraindication to breastfeeding and access to a mobile phone with unlimited text messaging capability who deliver a healthy term neonate will be eligible for inclusion. Consented women will be randomized to either text-based breastfeeding support using the Way to Health platform or usual care.

详细描述

Breastfeeding is a public health priority. The CDC and WHO, among other professional organizations, have issued the following recommendations with respect to breastmilk. Infants should be exclusively breastfed through the first 6 months of life and continue to receive breastmilk through at least the first year of life. Many women, however, are not meeting these benchmarks even among those who desire to do so. Approximately one quarter of infants are exclusively breastfed at 6 months and a little over 1/3 are still receiving breastmilk at the time of their 1st birthday.1 What looking at these numbers alone miss is the number of women who attempt to breastfeed and do not continue to do so. 83% of women attempt breastfeeding indicating that there is a significant drop off that occurs between delivery and 6 and 12 months of life.

While the risk factors for this are vast, lack of education poor socioeconomic status and poor social support are important contributors to breastfeeding problems. Both professional and informal support through family or friends have a significant impact on breastfeeding outcomes. Not all patients, however, have the resources needed to obtain professional support or the family experience necessary to meet their breastfeeding goals.

Digital support in other medical specialties have shown success in health outcomes. Multiple international studies have also demonstrated the benefits of text-messaging on breastfeeding rates including improved rates and duration of exclusivity. Thus far, none of these studies have been performed in the United States.

Therefore, the aim of this study is to determine if text-based breastfeeding support improves breastfeeding initiation, duration, and exclusivity when compared to usual postpartum care.

All women without a contraindication to breastfeeding and access to a mobile phone with unlimited text messaging capability will be approached in the 34-36 week of pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • •>18 years of age
  • •English-speaking
  • •Own a cellular phone with unlimited text-messaging
  • •Singleton gestation consented at 34-36 weeks of pregnancy
  • •Willing and able to sign consent form

排除标准

  • •Contraindication to breastfeeding
  • •Delivery of infant requiring ICN admission
  • •Physician discretion that patient will be unable to comply with the protocol

研究组 & 干预措施

Text-Based Support

Experimental

Text-Based Support - Women randomized to this arm will receive text-based support via the Way to Health platform as described below.

Supportive texts - Encouraging text messages with prompts to ask questions will be sent twice weekly during the first four weeks postpartum and once weekly thereafter for the remaining two weeks of the program

Inquiry texts - Questions regarding infant feeding with prompts to answer will be sent three times weekly during the first two weeks postpartum and twice weekly thereafter for the remaining 4 weeks of the program.

PHQ2 text - Women will be sent the PHQ2 at 2 weeks and 6 weeks postpartum to assess mood symptoms.

Women in this group will also have the option to send a text with a question or concern at any time during the study. Weekdays from 8am to 5 pm these will be fielded by a trained obstetrician. If a text is received after-hours or on the weekend, women will be instructed to reach out to their primary OBGYN provider.

干预措施: Text-Based Support (Behavioral)

Usual Care

No Intervention

Usual care - Women randomized to this arm will receive usual postpartum care with the following exceptions:

Inquiry texts- Questions regarding infant feeding with prompts to answer will be sent once weekly for all 6 weeks of the program.

PHQ2 text - Women will be sent the PHQ2 at 2 weeks and 6 weeks postpartum to assess mood symptoms.

Women in this group will be directed to their physician with any questions or concerns during the study period.

结局指标

主要结局

Exclusivity

时间窗: 6 weeks postpartum

Exclusive breastfeeding

次要结局

  • Any Breastfeeding(6 weeks postpartum)
  • Mood(2 and 6 weeks postpartum)
  • Duration(6 weeks postpartum)
  • Formula(6 weeks postpartum)
  • Compliance(6 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celeste Durnwald

Principal Investigator

University of Pennsylvania

研究点 (1)

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