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

15. ledna 2015 aktualizováno: Elena Bronshtein, Wayne State University

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).

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

200

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Control group
No intervention(control group)
Experimentální: condition 2
Intervention:Smokefreemoms texting
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 3
Intervention: Quitline referral
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 4
Intervention:Smokefreemoms texting and quitline referral
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 5
Intervention: Brief intervention
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 6
Intervention:Smokefreemoms texting and Brief intervention
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 7
Intervention: Quitline referral and Brief intervention
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.
Experimentální: condition 8
Intervention:Smokefreemoms texting, Quitline referral and Brief intervention
Behaviorální: Referral to SmokeFreeMoms, Quitline or Brief intervention
  1. SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
  2. The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
  3. Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Abstinence from smoking
Časové okno: 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.
Seven-day point-prevalence

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Wayne State University

Vyšetřovatelé

  • Ředitel studie: Robert Sokol, MD, WSU

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. ledna 2015

Primární dokončení (Očekávaný)

1. dubna 2015

Dokončení studie (Očekávaný)

1. května 2015

Termíny zápisu do studia

První předloženo

13. ledna 2015

První předloženo, které splnilo kritéria kontroly kvality

15. ledna 2015

První zveřejněno (Odhad)

16. ledna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

16. ledna 2015

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. ledna 2015

Naposledy ověřeno

1. ledna 2015

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • WayneSU

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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