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

January 15, 2015 updated by: 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • DMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
No intervention(control group)
Experimental: condition 2
Intervention:Smokefreemoms texting
Behavioral: 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
Behavioral: 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
Behavioral: 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
Behavioral: 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
Behavioral: 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
Behavioral: 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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abstinence from smoking
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Sokol, MD, WSU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WayneSU

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