Optimizing Technology-Delivered Interventions for Smoking in Pregnancy: The Mommy Check-Up Study.
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | January 2015 |
| End Date: | May 2015 |
| Contact: | Elena Bronshtein, MD |
| Email: | ebronsht@med.wayne.edu |
| Phone: | 313-577-4021 |
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).
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).
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.
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.
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.
We found this trial at
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