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临床试验/NCT02958475
NCT02958475已完成不适用

Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 346 人开始时间: 2017年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
346
试验地点
2
主要终点
Change in Breastfeeding exclusivity

研究概览

简要总结

This study is being conducted to evaluate the breastfeeding support program utilizing bilingual English-Spanish tailored text messages and online support to support exclusive and continuous breastfeeding for new mothers--comparing texting alone, texting with an online support group to those with usual care. The cost involved in moderating the online groups and providing bidirectional consultation when needed will be evaluated and qualitative feedback from a subset of mothers in both intervention groups will be evaluated to determine what was effective, as well as suggestions for improvement of the messaging program.

详细描述

Women of child-bearing age are in the generation most likely to use texting to communicate, and most own a cellular phone, and that cell phones have been demonstrated to be efficacious in increasing Human Immunodeficiency Virus (HIV) medication compliance and smoking cessation, and in improving diabetes management, the investigators consider this may be a promising strategy to increase breastfeeding. The investigators developed theoretically-based text message content along with breast feeding informational and video content designed for delivery via closed private groups on social media based on formative work and then conducted a pilot study to text the effects of interactive messaging sent over a 12 week period (i.e. 6 weeks prior and after birth) that targeted barriers (e.g. insufficient milk, pain/sore nipples, breastfeeding in public, among others) on exclusivity and continuation of breastfeeding. The investigators innovative approach, called Mother's Milk Messaging (MMM) specifically targets low-income and minority mothers and has the potential to reach unprecedented numbers of mothers, to be standardized for later scalability, and to be cost-effective.

While Text4Baby texting application uses a similar approach, the text messages are not interactive and they do not address specific issues with breastfeeding. The device's social media content facilitates private, peer and expert support for breastfeeding in real time on a channel preferred by first time mothers.

Applying a theoretically-based framework, the investigators developed content stemming from Dr. Maya Bunik's previous published Breastfeeding Telephone Triage and Advice. Content was adapted for delivery via a mobile application (App) with attention to an Integrated Theory of mobile Health (mHealth) using best practices for app design for health promotion using social and mobile technology. The content was modified to facilitate engagement with content using technology, utilizing communication theories such as Gain and Loss Framing and Elaboration theory, and theories to support social networking and social support, along with behavioral health theories such as the Theory of Planned Behavior and Social Cognitive Theory.

The MMM app has three main elements: text messages via push notification are stored and searchable on the app, access to a breastfeeding social support group on Facebook, and access to videos and written material to facilitate knowledge acquisition and skills building. The text messages are targeted at specific theoretical constructs such as outcome expectations/attitudes, barrier self-efficacy, reinforcing a message using peripheral (expert) opinion, eliciting a sense of social currency or providing a cue-to-action. The breastfeeding social support group on Facebook will be moderated to facilitate posting of shared experiences. Short videos, photographs, and written blurbs on related topics are posted on the Facebook page to reinforce the messaging and content of the texts. After a successful pilot study of MMM the investigators are ready to test the benefits of supporting new mothers with breastfeeding using the investigators bilingual mobile phone application (app) and online support program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are first time mothers
  • Women ages 18-40
  • Who can converse and write in English and/or Spanish
  • Who reside in the U.S.
  • Who are expecting a normal singleton birth
  • Who are pregnant
  • Have access to a computer connected to the Internet
  • Have access to a mobile device that can receive text messages and access the Internet (smart phone)

排除标准

  • Decisionally challenged

结局指标

主要结局

Change in Breastfeeding exclusivity

时间窗: Baseline, 3 and 6 months

Percent of exclusive feeds as a measured in the past 24 hrs (e.g. 80% breastmilk)

次要结局

  • Change in Breastfeeding Self-Efficacy Scale (BSES)(Baseline, 3 and 6 months)
  • Change in Iowa Infant Feeding Attitudes Scale (IIFAS)(Baseline, 3 and 6 months)
  • Change in Infant Feeding Intentions Scale (IFIS)(Baseline, 3 and 6 months)
  • Change in Social Support Questionnaire (SSQ6)(Baseline, 3 and 6 months)
  • Change in Perceived Breastfeeding Support Assessment Tool (PBSAT)(Baseline, 3 and 6 months)
  • The Bidirectional Acculturation Scale for Hispanic (BAS)(Baseline)
  • Change in Infant Feeding Practices Survey II (IFPS-II)(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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