Smoking Cessation Counseling for Pregnancy

Overseen By Sarah Hantzmon, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women quit smoking through text message support and training for their obstetricians. Women who smoke and are attending their first OB visit at Duke or Pitt may qualify. The trial will compare the effectiveness of personalized communication training for doctors (Clinician Communication Intervention) with standard smoking cessation lectures (5A's lecture). Participants will receive supportive text messages throughout their pregnancy to aid in quitting smoking. The study will evaluate how well these strategies improve smoking cessation rates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance support for pregnant women trying to quit smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for pregnant patients?

Research has shown that behavioral counseling is a safe and effective method to help pregnant women quit smoking. Studies indicate that counseling, especially when tailored for pregnant women, can assist them in stopping tobacco use with minimal risk.

The Clinician Communication Intervention under study is considered low risk, expected to be safe and manageable. This intervention trains healthcare providers to offer improved advice on quitting smoking, which has helped many pregnant women quit.

No evidence suggests harmful side effects from this type of intervention. In fact, similar counseling methods have been widely used and supported by numerous studies. These studies emphasize that counseling during pregnancy is not only safe but also crucial for the health of both the mother and baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to help pregnant individuals quit smoking through improved communication. Unlike standard smoking cessation methods that primarily focus on nicotine replacement or medication, this intervention enhances how clinicians communicate, providing them with specialized training. This tailored communication approach aims to make smoking cessation advice more relatable and effective for pregnant patients, potentially leading to better outcomes for both mother and child. By focusing on clinician-patient interactions, the trial could revolutionize how smoking cessation is approached during pregnancy, offering a fresh perspective beyond traditional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation during pregnancy?

Research shows that special communication training for doctors can significantly help pregnant women quit smoking. In this trial, clinicians in the intervention arm will receive tailored communication training on smoking cessation skills. Studies have shown that this training can increase quit rates by 30-70% for pregnant smokers. The 5As model—asking about smoking, advising to quit, assessing readiness, assisting with quitting, and arranging follow-up—has also proven effective. Clinicians in the control arm will attend a lecture on general information about smoking cessation for pregnant patients. Counseling specifically designed for pregnant women has shown even better results. While counseling and materials tailored for pregnant women have been helpful, some women may still find it challenging to quit. Overall, these methods have strong potential to help pregnant women stop smoking. ^{1 3 5 6 7}

Who Is on the Research Team?

Kathryn I Pollak, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 who smoke and are getting prenatal care from a participating OB clinician. They must have smoked tobacco at their first OB visit, be able to speak and read English, and have access to a cell phone that can send texts.

Inclusion Criteria

Receiving prenatal care from an enrolled OB clinician

Self-report smoking tobacco at their first OB visit

Access to a cell phone with texting capabilities

Exclusion Criteria

Unable to speak and read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention

Collection of pre-intervention audio-recorded initial OB visit encounters to assess clinician communication skills

3 weeks

Intervention

OB clinicians receive tailored training on smoking cessation skills; patients receive SMS smoking cessation messages

Throughout pregnancy

Post-Intervention

Assessment of the effect of the communication program by audio recording initial OB visits and surveying patients

Up to end-of-pregnancy

Follow-up

Participants are monitored for smoking cessation outcomes and surveyed at 6 weeks postpartum

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• 5A's lecture
• Clinician Communication Intervention

Trial Overview The study tests whether combining SMS smoking cessation messages with specialized training for OB clinicians improves quitting rates among pregnant smokers compared to just receiving the messages. Participants will be analyzed based on their quit rates and interactions with clinicians.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation.

Group II: Control Active Control 1 Intervention

Clinicians in the control arm will be asked to attend a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.

Clinician Communication Intervention is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Smoking Cessation Counseling for:

• Smoking cessation in pregnant women

Approved in European Union as 5 A's Intervention for:

• Smoking cessation in pregnant women
• General smoking cessation

Approved in Canada as Clinician Communication Intervention for:

• Smoking cessation in pregnant women

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

The percentage of pregnant individuals who smoke has decreased from 13.2% in 2006 to 7.2% in 2016, indicating progress in smoking cessation efforts during pregnancy.

Continued smoking during pregnancy is linked to serious risks for the fetus, such as low birth weight and developmental delays, highlighting the need for personalized treatment approaches that include behavioral counseling and pharmacotherapy to support cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine Use During Pregnancy: Cessation and Treatment Strategies. Shirwani, A., Kuller, JA., Dotters-Katz, SK., et al.[2023]

In a study of 269 resistant pregnant smokers, an intensified smoking cessation intervention showed modest effectiveness, with 43% of participants in the experimental group classified as non-smokers compared to 34% in the control group by the 34th week of pregnancy.

At 6 weeks postpartum, 27.1% of the experimental group reported being abstinent or light smokers, compared to 14.6% in the control group, indicating some short-term success of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-to-one: a motivational intervention for resistant pregnant smokers. Stotts, AL., Diclemente, CC., Dolan-Mullen, P.[2022]

Tobacco use during pregnancy poses significant health risks, but nurses can play a crucial role in helping pregnant women quit smoking by using specific tobacco control guidelines and tailored counseling.

The article discusses the Smoke Free Families program, which is designed for pregnant women and includes support for managing second-hand smoke, highlighting effective strategies for integrating smoking cessation into prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoke free families: a tobacco control program for pregnant women and their families. Pletsch, PK., Morgan, S.[2019]

Active and passive tobacco smoke exposure during pregnancy is a major preventable cause of negative health outcomes for mothers and infants in France, highlighting the urgent need for effective smoking cessation strategies.

The article outlines low-intensity interventions, such as CO monitoring and the 5 A's approach, that can be easily integrated into routine prenatal care to support pregnant women in quitting smoking, emphasizing the importance of tailored support in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. Stoebner-Delbarre, A., Letourmy, F.[2017]

A systematic office-based protocol that identifies and treats pregnant women who smoke has been shown to significantly increase smoking cessation rates.

For light to moderate smokers, a brief counseling session using pregnancy-specific educational materials can effectively support quitting, highlighting the importance of tailored interventions in improving pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACOG committee opinion. Number 316, October 2005. Smoking cessation during pregnancy. [2022]

An office-based protocol that identifies and treats pregnant women who smoke can significantly increase quit rates, with a 30-70% increase in cessation for those smoking less than 20 cigarettes per day.

The intervention includes a brief five-step counseling session and pregnancy-specific educational materials, highlighting its effectiveness in promoting smoking cessation during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation during pregnancy. [2015]

Many maternity care providers are not effectively assisting pregnant women in quitting smoking, likely due to doubts about their effectiveness and lack of reimbursement for counseling services.

Midwives, who possess strong counseling skills, can implement brief counseling sessions (5-10 minutes) during prenatal visits, which could increase smoking cessation rates by 10%-20%, benefiting both maternal and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple, effective method that midwives can use to help pregnant women stop smoking. Klerman, LV., Rooks, JP.[2019]

Pregnant women who smoke often do not quit despite knowing the risks, highlighting the need for effective interventions from healthcare providers.

Regular and constructive discussions about smoking at each medical visit can significantly improve the chances of pregnant women successfully quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making the sale: communicating the importance of smoking cessation to pregnant patients. Anderson, RH.[2017]

Smoking during pregnancy is a major cause of negative health outcomes for mothers and infants, making cessation crucial for improving pregnancy results.

Implementing an office-based protocol, like the 5A's intervention, which includes counseling and referrals to quit lines, has been shown to effectively increase smoking cessation rates among pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee opinion no. 471: Smoking cessation during pregnancy. [2010]

A randomized controlled trial involving 442 pregnant smokers found that proactive telephone counseling did not significantly outperform brief counseling in overall cessation rates, with 10.0% abstinence in the intervention group compared to 7.5% in the control group at the end of pregnancy.

However, the telephone counseling was particularly effective for light smokers and those who had previously attempted to quit, showing higher cessation rates of 19.1% and 18.1% respectively, indicating potential benefits for these specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Rigotti, NA., Park, ER., Regan, S., et al.[2022]

Cigarette smoking is a major modifiable risk factor for adverse pregnancy outcomes, and quitting smoking during pregnancy significantly reduces risks like fetal growth retardation and preterm delivery.

Healthcare provider interventions, including screening and counseling, are effective in promoting smoking cessation among pregnant women, and additional resources and support systems are essential for maintaining long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation in pregnant women. Klesges, LM., Johnson, KC., Ward, KD., et al.[2019]

The implementation of an Inspectorate's supervision program led to a significant increase in smoking-cessation counseling provided by Dutch midwifery practices, with the use of a minimal-intervention strategy rising from 28% to 80%.

While the program's different assessment methods (questionnaire and site visits) showed varying levels of improvement, overall participation in counseling training increased across all practices after the program began, indicating a positive impact on smoking cessation efforts during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does government supervision improve stop-smoking counseling in midwifery practices? Oude Wesselink, SF., Lingsma, HF., Reulings, PG., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10259542/

Effectiveness of brief counseling (5As): Antenatal tobacco ... Our aim was to study the effectiveness of brief counseling (5As)—Antenatal Tobacco Cessation Support Program among pregnant women availing ...

2. withpower.com withpower.com/trial/phase-2022-aef6a

Smoking Cessation Counseling for Pregnancy An office-based protocol that identifies and treats pregnant women who smoke can significantly increase quit rates, with a 30-70% increase in cessation for ...

3. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/Factors-associated-with-the-implementation-of-the-5As-model-nof-smoking-cessation,169623,0,2.html

Factors associated with the implementation of the 5As ... In pregnant women, the 5As model seems to be effective if the intervention is context sensitive. This model is supported by a high level of ...

4. pneumon.org pneumon.org/pdf-136945-67269?filename=67269.pdf

Interventions for smoking cessation during pregnancy Smoking cessation has been found to contribute to a decrease in low birth weight and prematu- rity rates and reduced needs for health care in childhood.

5. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2020/05/tobacco-and-nicotine-cessation-during-pregnancy

Tobacco and Nicotine Cessation During Pregnancy Although counseling and pregnancy-specific materials are effective cessation aids for many pregnant women, some women continue to use tobacco products.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555596/

Interventions for Smoking Cessation and Treatments ... - NCBI A large number of high-quality studies continues to support the use of behavioral counseling, pharmacologic interventions, and combined counseling and ...

7. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions-september-2015

Tobacco Smoking Cessation in Adults, Including Pregnant ... Effective behavioral interventions in pregnant women who smoke include counseling, feedback, health education, incentives, and social support.