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

15. Januar 2015 aktualisiert von: 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).

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 45 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control group
No intervention(control group)
Experimental: condition 2
Intervention:Smokefreemoms texting
Verhalten: 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.
Experimental: condition 3
Intervention: Quitline referral
Verhalten: 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.
Experimental: condition 4
Intervention:Smokefreemoms texting and quitline referral
Verhalten: 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.
Experimental: condition 5
Intervention: Brief intervention
Verhalten: 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.
Experimental: condition 6
Intervention:Smokefreemoms texting and Brief intervention
Verhalten: 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.
Experimental: condition 7
Intervention: Quitline referral and Brief intervention
Verhalten: 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.
Experimental: condition 8
Intervention:Smokefreemoms texting, Quitline referral and Brief intervention
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Abstinence from smoking
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wayne State University

Ermittler

  • Studienleiter: Robert Sokol, MD, WSU

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2015

Primärer Abschluss (Voraussichtlich)

1. April 2015

Studienabschluss (Voraussichtlich)

1. Mai 2015

Studienanmeldedaten

Zuerst eingereicht

13. Januar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Januar 2015

Zuerst gepostet (Schätzen)

16. Januar 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

16. Januar 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Januar 2015

Zuletzt verifiziert

1. Januar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • WayneSU

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