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

Trial Summary

What is the purpose of this trial?

The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.

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 data supports the effectiveness of the 5A's treatment for smoking cessation during pregnancy?

Research shows that a structured office-based approach, like the 5A's treatment, which includes identifying pregnant women who smoke and providing counseling, can significantly increase quit rates. Specifically, a 5-15 minute counseling session with pregnancy-specific educational materials can boost cessation rates by 30-70% for women who smoke less than 20 cigarettes per day. ^{1 2 3 4 5}

Is smoking cessation counseling safe for pregnant women?

The research does not specifically mention any safety concerns related to smoking cessation counseling for pregnant women, suggesting it is generally considered safe. The focus is on the benefits of quitting smoking during pregnancy to prevent harm to both the mother and baby. ^{3 6 7 8 9}

How is the Clinician Communication Intervention treatment for smoking cessation during pregnancy different from other treatments?

The Clinician Communication Intervention is unique because it focuses on personalized counseling by healthcare providers using the 5 A's approach (Ask, Advise, Assess, Assist, Arrange), which is specifically tailored for pregnant women. This method emphasizes direct communication and support from clinicians, making it distinct from other treatments like telephone counseling or self-help materials. ^{6 8 10 11 12}

Research Team

Kathryn I Pollak, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

I am 18 years old or older.

Exclusion Criteria

Unable to speak and read English

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation in pregnant women. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation during pregnancy. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

One-to-one: a motivational intervention for resistant pregnant smokers. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Nicotine Use During Pregnancy: Cessation and Treatment Strategies. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Does government supervision improve stop-smoking counseling in midwifery practices? [2022]

9. France pubmed.ncbi.nlm.nih.gov

[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Smoke free families: a tobacco control program for pregnant women and their families. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

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