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临床试验/NCT02340624
NCT02340624Unknown不适用

Optimizing Technology-Delivered Interventions for Smoking in Pregnancy: The Mommy Check-Up Study.

Wayne State University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Abstinence from smoking

研究概览

简要总结

Tobacco smoking in pregnancy remains one of the most important and preventable cause of adverse pregnancy outcomes. Data from National Survey of Drug Use and Health (NSDUH) suggests, that the annual average rates of current cigarette use among women aged 15 to 44 who were not pregnant decreased from 30.7 percent in 2002-2003 to 24.0 percent in 2012-2013. However, the prevalence of cigarette use among pregnant women in this age range did not change significantly during the same time period (18.0 percent in 2002-2003 and 15.4 percent in 2012-2013)Smoking cigarettes during pregnancy and nursing causes considerable health damage to the fetus and to the infant during the initial growth phase. An estimated 19.8 million women in the United States smoke. Nationally, 23 percent of women report smoking in the 3 months before pregnancy, while 13 percent report smoking in the last 3 months of pregnancy. Overwhelming evidence suggests that maternal smoking during pregnancy is associated with an adverse pregnancy outcomes including IUGR, placenta previa, abruption placentae, preterm premature rupture of membranes, low birth weight, perinatal mortality, intrapartum stillbirth and ectopic pregnancy. Moreover, prenatal exposure to tobacco smoke also increases risk of attention deficit and hyperactivity disorder (ADHD) and sudden infant death syndrome (SIDS) in the offspring.Children born to mothers who smoke during pregnancy are at increased risk of asthma, infantile colic, and childhood obesity.

Brief interventions are shown to be associated with small but clear increases in smoking cessation in pregnancy, but are rarely used. Technology may fill this void. For the present study, pregnant women reporting smoking during pregnancy will be recruited and randomly assigned to one of eight combinations of three technology-delivered intervention approaches: Brief intervention, Quitline referral, and "SmokeFreeMoms" text messages (http://women.smokefree.gov/smokefreemom.aspx).

详细描述

The study will be introduced to pregnant smokers age 18-45 by clinic staff at the DMC prenatal care clinic located at the University Health Center, or at a UPG prenatal care clinic. Medical staff will give potential participants a flyer briefly describing the study and providing a link to a website (www.mommycheckup.net). Participants who meet all inclusions and exclusion criteria and pass the quiz will be randomized to one of the eight possible combinations of the three different interventions: Brief intervention, SmokeFreeMoms texting, or Quitline referral. This use of a factorial design to examine the relative efficacy of various intervention components is consistent with the Multiphase Optimization Strategy (the MOST) approach. Follow-up evaluation will take place at 4 weeks, and will have two elements, one computer- or mobile device-based and the other involving provision of a saliva/urine and breath sample. These will be done separately (if the participant does the online version remotely) or together (if the participant does the online component while providing the samples). Online follow-up: Participants will be sent a link to the online system, through which they will be asked about smoking. The clinic follow-up assessment will be performed at the next clinic visit. All participants will be asked to provide a urine sample (to be tested for cotinine, a biomarker of cigarette smoking) and a breath sample (to be tested for carbon monoxide level).

Data will be analyzed using a 2 (brief intervention yes vs. no)) X 2 (texting referral yes-no) X 2 (quitline referral yes-no) ANCOVA (controlling for baseline smoking) test with a power of 75%, α=0.05, and 200 patients will be required for this study. The information will be analyzed using SPSS. We will examine main effects for each of the three factors. Based on an incidence of tobacco smoke in pregnancy, the total recruitment will take 3-4 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant women age 18-45, at less than 30 weeks gestation, who smoke daily, have access to a mobile device and are willing to accept text messages.

排除标准

  • •not having access to a mobile device with a texting plan.

研究组 & 干预措施

Control group

No Intervention

No intervention(control group)

condition 2

Experimental

Intervention:Smokefreemoms texting

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 3

Experimental

Intervention: Quitline referral

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 4

Experimental

Intervention:Smokefreemoms texting and quitline referral

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 5

Experimental

Intervention: Brief intervention

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 6

Experimental

Intervention:Smokefreemoms texting and Brief intervention

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 7

Experimental

Intervention: Quitline referral and Brief intervention

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

condition 8

Experimental

Intervention:Smokefreemoms texting, Quitline referral and Brief intervention

干预措施: Referral to SmokeFreeMoms, Quitline or Brief intervention (Behavioral)

结局指标

主要结局

Abstinence from smoking

时间窗: Seven-day point-prevalence

To compare the effects on smoking of an online brief intervention to those of referral to a free online text messaging intervention, and to those of free phone counseling through the Michigan Quitline.

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

Elena Bronshtein

MFM Fellow

Wayne State University

研究点 (1)

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