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Smoking CessationNCT03024606

Smoking Cessation Intervention in Pregnant Women

A study testing text messages focused on smoking cessation and pregnancy in people with Smoking Cessation, run by St. Louis University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change… Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
Smoking Cessation
What is being tested?
text messages focused on smoking cessation and pregnancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
No sites listed yet
Study dates
Mar 2014to 14 Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Have a confirmed pregnancy,
  • English speaking,
  • 18-55 years of age,
  • Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
  • Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
  • Willing and able to commit to the visit schedule

Who cannot join

  • Gestational age > 35 weeks at quit date
  • If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.

About this study

Official title: Smoking Cessation Following Text Message Intervention in Pregnant Women

The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.

Read the detailed description

Smoking during pregnancy has been shown to have detrimental effects on both the mother and the fetus. The perinatal period presents a critical opportunity to educate and support the mother as she attempts quit. Current studies suggest a median quit rate of only 4.9% in women receiving usual care (Cognitive Behavioral Therapy, CBT), but a number of studies have investigated new interventions in addition to usual care to help increase compliance with smoking cessation. Pharmacological aids such as nicotine replacement therapy (NRT) and bupropion are recommended as potential options by the American College of Obstetrics and Gynecology since they are considered safer than continued smoking during pregnancy. Studies thus far on smoking cessation with the help of electronic devices have demonstrated mixed results; however, the impact of texting in the pregnant population in combination with CBT and pharmacological therapy has yet to be assessed.

Smoking during pregnancy has been shown to have detrimental effects on both the mother and the fetus. Cigarettes contain over 3000 compounds many of which can cause risk to pregnancy. However, the nicotine and carbon monoxide components are of primary concern. Nicotine releases epinephrine, which results in a decrease in uterine blood flow and an increase in uterine resistance. There is also decreased production of fetal nitric oxide resulting in lower blood flow to the fetus and leading to decreased birth weight, length, and head circumference compared to non-smokers.

Studies have proven that exposure to tobacco can increase the risk for placental abruption, placental previa, preterm birth, antenatal death, sudden infant death syndromes, attention-deficit/hyperactivity disorder and asthma. Compared to children of non-smoking mothers, children of mothers who smoked during pregnancy had a higher BMI and increased odds for being overweight at 4-years of age; however, in the children whose mother quit smoking during pregnancy there was no increased risk of increased BMI or being overweight compared to the children of non-smoking mothers. According to the data from the 2009 Pregnancy Risk Assessment and Monitoring System (PRAMS) approximately 12.4% of pregnant women with live births reported smoking during the last three months of pregnancy (PRAMS). Of the 25% of women who smoked in the 3 months prior to pregnancy, 52% quit during pregnancy; of those, 44% relapsed within 6 months after delivery. The perinatal period presents a critical opportunity to educate and support the mother as she attempts quit.

Current studies evaluating rates of smoking cessation in pregnant women show less than ideal results. A primary analysis of 12 pooled trials found a median quit rate of 4.9% in women with usual care. This rate increased to 13.2% in patients that received tailored self-help intervention.12 To help increase compliance with cessation, studies have investigated new interventions as part of the usual care provided to pregnant patients that continue to smoke. One study looked at including a 15-minute video and provider prompting at baseline and one month. Although a higher percentage of patients in the intervention group had a higher 30-day abstinence rate at 2-months post baseline, the finding was not significant (26.1% vs 10.5%, p=0.12) although the study did not discuss if this was an appropriately powered sample size. Another study looking at the combination of smoking cessation education, physical activity counseling and supervised exercise found a 25% abstinence rate at 8-months gestation. The use of NRT has also been studied. One study found that CBT plus NRT verses CBT alone was effective at 7-weeks (24% vs 8%, p=0.02) and 38-weeks' gestation (18% vs 7%, p=0.04), unfortunately there was no benefit at 3-months post-partum (20% vs. 14%, p=0.55).

The use of pharmacological aids for smoking cessation is recommended as a potential option by the American College of Obstetrics and Gynecology. Currently, NRT products and bupropion are appropriate options during pregnancy and are the most utilized therapy for cessation during pregnancy. Although classified as pregnancy category-D medication, NRT patches are often used to assist the pregnant patient in smoking cessation when CBT is not successful. A review looking at 4-studies that examined pregnancy outcomes after NRT, found a significant decrease in the risk of preterm delivery and low-birth weight compared to active smokers. NRT is considered safer than continued smoking since it only provides nicotine whereas smoking provides nicotine plus over 3000 other chemicals. It has also improved cessation rates near the quit date compared to CBT in obstetric patients. Similarly, bupropion has improved cessation rates in non-obstetric patients and has not been associated with malformations or abnormal pregnancy outcomes.

The transtheoretical stages of change assessment is beneficial to help determine a patient's readiness to quit. Data has shown that the stages predict preparation for cessation and successful cessation. In the precontemplative stage, patients are not willing to consider smoking cessation. The contemplative stage is defined as patients considering smoking cessation but not ready to set a quit date. Preparation stage occurs when patient is ready to set a quit date within the next 30 days. In the action stage, patients have been smoke free for less than six months. Maintenance stage is cessation longer than 6 months. Relapse is when patients have starting smoking again after being in the action stage. In other obstetric smoking cessation literature, relapse has been defined as smoking more than 5 cigarettes or smoking more than 5 times since cessation.

Mobile technology is common place in today's society. According to the 2013 Nielsen report, 94% of all Americans 16 years of age or older use a cellular phone with more than half of those being smart phones. A total of 96% of phone owners have a data plan included. In 2012, the average monthly usage included 164.5 calls, 644.1 voice minutes, and 764.2 text messages. Ownership of cell phones and high tech devices extends to all socioeconomic classes, and the ease and affordability has made cell phone use common for all races and income brackets. When looking at text message specifically for race 79% of whites, 85% of Blacks and 87% of Hispanics report text messaging. When looking at household income 78% of those making < 30K, 80% of those making between 30k-50k, and 88% of those making greater than 50k are active texters. African Americans are more likely than the general population to own smart phones (71% vs. 62%) and are 44% more likely than the broader market to create a social media profile. Over a monthly basis, African Americans also spend 24% more time on their phone , 12% more time on email, and 10% more time on the internet. Hispanics text the greatest of all ethnic groups at 943 text messages per month. Based on this data, it is apparent that mobile phone messaging is a potential convenient and cost-effective way to interact with patients of all races and income levels.

Results of current studies looking at smoking cessation with the help of computer or other electronic device are mixed. Several trials have looked at the use of text-messaging based smoking cessation programs. One randomized controlled pilot trial of 151 daily smokers interested in quitting found a non-clinically significant difference in cessation rates at 3 months between the intervention and control groups (11% versus 4%), this study was not powered to detect a statistical difference. A small pilot study evaluating Text2Quit, an automated, personalized, and interactive program that sends texts and emails over the course of 3 months, reported liking the program at 2 and 4 weeks after enrollment (91% and 82%, respectively) and 75% of participants reported reading most or all of the messages sent. Unfortunately, the majority of participants admitted to smoking at the 4-week visit. The txt2stop study was a trial of 5800 smokers that were randomized to receive text messages that were comprised of motivational and behaviour-change support versus the control group who received text messages unrelated to quitting. At 6-months abstinence was significantly increased in the intervention group versus the control group (10.7% vs. 4.9%; p<0.0001).

Being tested
text messages focused on smoking cessation and pregnancy
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • text messages focused on smoking cessation and pregnancyBehavioural

    The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.

Study groups in NCT03024606
Study groupRoleWhat they receive
texting groupActive comparatortext messages focused on smoking cessation and pregnancy
Receives: Behavioral: text messages focused on smoking cessation and pregnancy
control groupNo interventionNo text messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exhaled Carbon Monoxide Levels

    self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2017 (estimated)
  2. Study startMar 2014
  3. Primary completion14 Jun 2017
  4. Study completion14 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024606
Sponsor's protocol ID
23943
Status last verified
Oct 2018
First submitted
13 Jan 2017
Last updated
24 Oct 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PubMed 32813276
  • Forinash AB, Yancey A, Chamness D, Koerner J, Inteso C, Miller C, Gross G, Mathews K. Smoking Cessation Following Text Message Intervention in Pregnant Women. Ann Pharmacother. 2018 Nov;52(11):1109-1116. doi: 10.1177/1060028018780448. Epub 2018 Jun 1.

    PubMed 29857773

Questions about this trial

What is this clinical trial studying?

A study testing text messages focused on smoking cessation and pregnancy in people with Smoking Cessation, run by St. Louis University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exhaled Carbon Monoxide Levels (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024606, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.

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