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临床试验/NCT04670822
NCT04670822已完成不适用

Postpartum Smoking Relapse Prevention by Breastfeeding Promotion

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月31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
60
试验地点
2
主要终点
Number of Participants Reporting to Breastfeed

研究概览

简要总结

This is a randomized controlled trial to prevent postpartum smoking relapse by breastfeeding promotion. The intervention group (N=30) will receive multicomponent breastfeeding intervention from late pregnancy to 6 months postpartum, while the attention placebo control group (N=30) will receive general infant care counseling and support. The key outcome is the rate of postpartum smoking relapse.

详细描述

The investigators propose the first randomized controlled trial to reduce postpartum smoking relapse by breastfeeding promotion from late pregnancy to 6 months postpartum. The investigators will enroll 60 pregnant women who successfully quit smoking within 3 months before or during this pregnancy (<28 weeks). All participants will receive breastfeeding education during late pregnancy. Right after delivery, participants who are still smoking abstinent will be randomized into either the breastfeeding intervention group (N=30) or the attention placebo control group (N=30). The intervention group will receive multicomponent interventions consisting of postnatal lactation counseling, family/peer/employer support, contingent financial incentives, and early limited formula milk via syringe (optional for at-risk infants). The control group will receive counseling and support focusing on general infant care with attention and compensation similar to the intervention group. The primary outcomes are rates of postpartum smoking relapse verified by urine cotinine test.

Specific Aim 1 is to examine the efficacy of breastfeeding promotion intervention on postpartum smoking relapse. Specific Aim 2 is to collect preliminary data regarding potential mediating mechanisms: increases in lactation hormones (plasma oxytocin and prolactin), reductions in stress and negative affect, and enhancing mother-infant bonding and maternal motivation to protect the infant from secondhand smoke exposure. This innovative and feasible pilot study can yield promising preliminary data to strongly support our future application of a NIH R01 grant proposal that has the potential to reduce smoking-related harms to both the mother and the infant, and maximize the protective effects of breastfeeding on infant health and development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Be pregnant or in the first 1 month postpartum
  • Be 18 years or older
  • Have quit smoking cigarettes during or before this pregnancy
  • Be willing to receive infant care and breastfeeding education
  • Be able to read, listen, and talk in English

排除标准

  • Medical conditions contraindicating breastfeeding such as HIV infection, active tuberculosis, and breast removal
  • Current heavy drinking (more than 2 drinks a day)
  • Current use of illicit substances
  • Being strongly against breastfeeding

研究组 & 干预措施

Breastfeeding intervention group

Experimental

A multicomponent behavioral intervention to promote breastfeeding

干预措施: Breastfeeding promotion (Behavioral)

Attention placebo control group

Placebo Comparator

General infant care counseling and support

干预措施: Attention placebo control (Behavioral)

结局指标

主要结局

Number of Participants Reporting to Breastfeed

时间窗: 9 months postpartum

During postpartum, mothers report their breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 9 months postpartum. Any breastfeeding is defined as exclusive breastfeeding or mixed-feeding breast milk and formula.

次要结局

未报告次要终点

研究者

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

Xiaozhong Wen

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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