Healthy Moms: Prenatal Counseling for Postpartum Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Duration of breastfeeding
研究概览
简要总结
See https://studypages.com/s/healthy-moms-study-765273
This individual-level randomized trial involves pregnant women followed for at least 6 months after delivery, to compare the effects of providing two "attention-control" counseling interventions designed to increase pregnant women's awareness of either:
- the maternal health benefits of breastfeeding, or
- the health benefits of smoke-free homes
详细描述
The investigators will conduct an individual-level randomized trial involving pregnant women to compare the effects on infant feeding practices of providing pregnant women information about the maternal health benefits of breastfeeding to usual prenatal counseling focused on the infant health benefits of breastfeeding. Participants will be randomly allocated to one of two equal sized groups by research assistants using a web-based random number generator that conceals allocation. Participants will be recruited online via UC Davis' StudyPages website. Screening will occur online at the participant's convenience. When screening criteria have been met, the research coordinator will be notified, and initiate contact with the participant by text and/or phone call to schedule a time to deliver the intervention. Due to social distancing measures that have been put into place as a result of the COVID-19 pandemic, informed consent will be collected digitally using the Qualtrics platform after potential participants complete a secondary screening survey. Consenting participants will use Qualtrics to complete a baseline/enrollment survey and be randomized and then scheduled for a time to receive their allocated counseling intervention using the Zoom platform. Follow-up surveys will be distributed to participants at 1, 3, 6, 9 and 12 months postpartum.
Comparators:
Participants randomized to the "intervention group" will receive information about the maternal health benefits of breastfeeding from a research assistant who also will provide information on resources designed to support prenatal and postpartum health, including breastfeeding support groups. Participants will be presented with a series of images to look at while listening to the scripted counseling, including an image developed in 2002 by the Ad Council designed to convey a link between bottle-feeding and insulin use, as well as images developed specifically for use when counseling women about the maternal benefits of breastfeeding.
The "attention control" group will receive "usual care" from their prenatal care provider that focuses on the infant health benefits of breastfeeding. To control for the potential effects of receiving additional attention from a counselor, pregnant women enrolled in the control arm of this study will receive information from a peer counselor on the health benefits of "smoke- and weed-free homes".
The investigators will thoroughly train all research staff on the critical importance of delivering only the allocated counseling intervention to each study participant. The investigators will monitor intervention delivery by audio-recording staff interactions with study participants, and providing prompt feedback to research staff, if needed.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women who are carrying a singleton pregnancy between 27-37 weeks gestation
- •Born in the United States
- •Aged 18-40 years
- •Able to read English
- •Have reliable access to a telephone that is able to send and receive text messages
- •Have reliable access to a smart phone, tablet, computer, or other device with access to the internet
排除标准
- •Women carrying multiple gestations
- •Diagnosed with HIV or are advised by a clinician not to breastfeed for any other reason
- •Have undergone mastectomy or breast reduction surgery
- •Unable to speak English, or who do not have a telephone or respond to text messages
- •Carrying a surrogate pregnancy or are not planning to parent after giving birth
- •Became pregnant through use of assisted reproductive technology such as in vitro fertilization (IVF)
结局指标
主要结局
Duration of breastfeeding
时间窗: at 6 months postpartum
Total number of weeks of breastfeeding
次要结局
- Duration of any breastfeeding or pumping at 24 months postpartum(24 months postpartum)
- Smoke-free home policy(1 month postpartum)
- Knowledge of the maternal health benefits of lactation(1 month postpartum)