Optimizing Technology-Delivered Interventions for Smoking in Pregnancy: The Mommy Check-Up Study.
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).
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Detroit、Michigan、アメリカ、48201
- DMC
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- not having access to a mobile device with a texting plan.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control group
No intervention(control group)
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実験的：condition 2
Intervention:Smokefreemoms texting
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実験的：condition 3
Intervention: Quitline referral
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実験的：condition 4
Intervention:Smokefreemoms texting and quitline referral
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実験的：condition 5
Intervention: Brief intervention
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実験的：condition 6
Intervention:Smokefreemoms texting and Brief intervention
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実験的：condition 7
Intervention: Quitline referral and Brief intervention
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実験的：condition 8
Intervention:Smokefreemoms texting, Quitline referral and Brief intervention
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Abstinence from smoking
時間枠：Seven-day point-prevalence
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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.
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Seven-day point-prevalence
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Robert Sokol, MD、WSU
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- WayneSU
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