Smoking Cessation Interventions for Pregnant Women

Overseen By Jan Blalock

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-Texas residence, Non-smoker, others

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

Compensation: Varies

Number of Visits: 9

Duration: Prenatal period and up to 4 months postpartum

54158 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 by making smoking cessation services more accessible. It offers various support options, such as counseling sessions (Tobacco Cessation Counseling), a wellness app, and resources to create a smoke-free home. The goal is to support healthy choices during pregnancy and the first months after childbirth. Pregnant women living in Texas who smoke or allow smoking at home and receive services at certain clinics may be a good fit for this study. As an unphased trial, this study provides a unique opportunity to access personalized support and resources to improve health outcomes for both mother and baby.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation for pregnant women, so it's best to discuss your medications with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that counseling offers a safe and effective method for pregnant women to quit smoking. Studies indicate that thorough counseling can significantly increase the number of pregnant women who stop smoking. Quitting during pregnancy reduces health risks for both mother and baby.

Various methods have been tested to aid pregnant women in quitting smoking. Some studies have focused on digital tools, such as smartphone apps, which safely support the quitting process. These tools provide information and tips on quitting smoking, serving as a useful complement to counseling.

Overall, both counseling and digital tools have proven safe and effective in helping pregnant women quit smoking. They offer a non-invasive way to promote healthier choices during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for smoking cessation in pregnant women because they integrate modern technology and personalized support, which are not commonly emphasized in standard treatments like nicotine replacement therapy or prescription medications. One of the standout features is the use of a Pregnancy and Wellness smartphone app, which offers wellness messages, smoking cessation information, and relapse prevention tips right at the user's fingertips. Additionally, the trial includes tailored telephone counseling sessions and tools for creating smoke-free homes, providing a comprehensive approach that addresses both behavioral change and environmental factors. This combination of tech-driven support and personalized counseling aims to make quitting smoking more accessible and effective for pregnant women, potentially leading to better outcomes for both mothers and babies.

What evidence suggests that this trial's treatments could be effective for smoking cessation in pregnant women?

This trial will evaluate different smoking cessation interventions for pregnant women. Participants may receive counseling, which studies have shown can significantly help pregnant women quit smoking, increasing the chances of quitting during pregnancy by 41%. Another group will use the Wellness app; research shows that smartphone tools can aid in quitting, though results may vary. Additionally, some participants will receive the Smoke-Free Homes kit, which has successfully made homes smoke-free, reducing secondhand smoke exposure—crucial for pregnant women. Overall, these methods hold promise for helping pregnant women stop smoking and create healthier environments for their babies. ^{6 7 8 9 10}

Who Is on the Research Team?

Jan Blalock

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for low-income pregnant women in Northeast Texas who smoke or allow smoking at home. It's also open to household members who smoke. Participants must be receiving services from WIC or FQHC clinics, consent to surveys, and speak English or Spanish.

Inclusion Criteria

PRE-TEST SURVEY FOR PREGNANT WOMEN: Consent to take surveys

PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently pregnant

PRE-TEST SURVEY FOR PREGNANT WOMEN: Reside in Texas

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telephone counseling sessions and use the Wellness app for smoking cessation and relapse prevention

Prenatal period and up to 4 months postpartum

6 sessions (prenatal), 4-6 sessions (postpartum)

Smoke-Free Homes Intervention

Participants receive the Smoke-Free Homes kit and coaching to establish a smoke-free home environment

6 weeks

3 mailings, 1 coaching call

Follow-up

Participants are monitored for effectiveness of smoking cessation and smoke-free home interventions

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Media Intervention
• Smoking Cessation Intervention
• Telephone-Based Intervention
• Tobacco Cessation Counseling

Trial Overview The study tests a program designed to help pregnant women quit smoking through counseling, telephone support, educational materials, and surveys. The goal is to reduce cancer risks associated with smoking and improve birth outcomes.

How Is the Trial Designed?

Group I: Goal 4 (counseling) Experimental Treatment 4 Interventions

Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.

Group II: Goal 3 (Smoke-free Homes) Experimental Treatment 5 Interventions

Participants receive the Smoke-Free Homes kit providing guidance for how to talk with household members and visitors about not smoking inside the home. Participants may also receive 3 separate Smoke-Free Homes mailings over 6 weeks, and a coaching call from a Baby Steps for Health counselor to help follow the steps described in the mailed materials in order to set up a smoke-free home.

Group III: Goal 2 (counseling, Wellness app, self-help) Experimental Treatment 6 Interventions

Participants receive telephone counseling sessions over 30-45 minutes for a minimum of 6 sessions in the prenatal period and about 4-6 postpartum period. Participants who start counseling after birth, may receive 6-8 sessions up to 4 months postpartum. Participants may also use the Pregnancy and Wellness smartphone app that provides wellness messages, smoking cessation information, relapse prevention tips, and tips to create a smoke-free home. Participants also receive tobacco cessation self-help materials including National Partnership for Smoke Free Families and Forever Free Baby and Me.

Group IV: Goal 1 (Wellness app) Experimental Treatment 4 Interventions

Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Pregnant women are more likely to quit smoking, making pregnancy a crucial time for healthcare providers to offer support for cessation, which benefits both maternal and fetal health.

Non-pharmacological support is the primary recommendation for helping pregnant smokers quit, with options like counseling and behavioral interventions, while nicotine replacement therapy can be used cautiously if necessary, focusing on oral formulations and shorter treatment durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical support of cessation for pregnant smokers]. Watti, J., Pócs, D., Tari, G., et al.[2023]

Episodic future thinking (EFT) shows promise as an intervention for reducing problematic substance use and substance use disorders, based on a systematic review of 16 studies that demonstrated benefits in self-reported and task-based outcomes.

The review highlights the need for further research to assess the feasibility, generalizability, and long-term effects of EFT, as well as to identify factors that influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. Collado, A., Stokes, A.[2023]

The combination of cognitive-behavioral treatment (CBT) and episodic future thinking (EFT) for smoking cessation in a group of 29 smokers with substance use disorders was found to be acceptable, with a high satisfaction rating of 8.83 out of 10.

Despite the positive reception, adherence to the EFT component was low, with only 15.8% of participants practicing it as recommended, indicating a need for adjustments in future studies to enhance compliance and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. Aonso-Diego, G., González-Roz, A., Martínez-Loredo, V., et al.[2021]

The clinic-based smoking cessation intervention was positively received by pregnant women, with five participants quitting smoking and five reducing their intake, highlighting its effectiveness in promoting behavioral change.

The intervention fostered a sense of competence and social support among participants, encouraging them to move from feelings of hopelessness to actively engaging in quitting smoking, suggesting it should be integrated into routine clinic services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnant women's responses to a tailored smoking cessation intervention: turning hopelessness into competence. Petersen, Z., Steyn, K., Everett-Murphy, K., et al.[2021]

Extended cognitive behavior therapy (CBT) significantly improved smoking abstinence rates at the 20-week follow-up, with 45% of participants achieving abstinence compared to 29% in the control group, indicating its effectiveness in promoting longer-term cessation.

While the difference in abstinence rates at 52 weeks was not significant (31% vs. 27%), the study suggests that CBT may help smokers maintain non-smoking status, especially for those with a history of depression who responded better to less intensive support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended cognitive behavior therapy for cigarette smoking cessation. Killen, JD., Fortmann, SP., Schatzberg, AF., et al.[2022]

Nicotine replacement therapy (NRT) is recommended as the safest and most effective option for helping pregnant women quit smoking, as other pharmacological treatments lack proven safety during pregnancy.

The review highlights the importance of assisting pregnant smokers in cessation efforts to reduce risks to both the mother and developing fetus, emphasizing the need for effective management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation in pregnancy. Rore, C., Brace, V., Danielian, P., et al.[2019]

Nurse-managed smoking cessation programs, which include a 15-minute personalized counseling session followed by a follow-up call, have shown to be one of the most effective interventions for helping pregnant women quit smoking, as measured by cotinine-validated abstinence.

Other approaches like nicotine replacement, hypnosis, and behavioral modifications were also evaluated, but more research is needed to determine their effectiveness in smoking cessation during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful interventions for smoking cessation in pregnancy. Barron, J., Petrilli, F., Strath, L., et al.[2019]

The addition of contingency management (CM) to cognitive behavioral treatment (CBT) with episodic future thinking (EFT) significantly increased 24-hour tobacco abstinence rates from 20% to 50% among 54 treatment-seeking participants, indicating a more effective approach for smoking cessation.

While not statistically significant, the CM group showed improved in-treatment behaviors such as higher retention rates and more sessions attended, suggesting that CM may enhance overall treatment engagement and adherence to nicotine reduction guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among individuals with substance use disorders: In-treatment and post-treatment effects. Aonso-Diego, G., González-Roz, A., Krotter, A., et al.[2021]

Cognitive-behavioral therapy for smoking cessation during pregnancy was effective, with 44% of the 74 participating women remaining abstinent until childbirth, and 93.1% of those abstinent maintained their status during the postpartum period.

Risk factors for treatment failure included having someone who smokes at home, a higher degree of nicotine dependence, and consuming more than three cups of coffee daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency and risk factors in the cognitive-behavioural treatment for smoking cessation in pregnancy]. Godá, T., Marcos, T., Corominas, J., et al.[2019]

Clinicians play a crucial role in identifying tobacco use and implementing effective behavioral interventions to assist patients in quitting, highlighting the importance of personalized quit plans.

The article discusses the latest pharmacotherapy options and the growing acceptance of e-cigarettes as potential tools for tobacco cessation, indicating a shift in strategies for helping patients quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: Identifying readiness to quit and designing a plan. Olenik, A., Mospan, CM.[2018]

Episodic future thinking (EFT) significantly reduces delay discounting and cigarette craving among smokers, suggesting it may help in smoking cessation efforts.

Imagining smoking-related illness (SRI) increased delay discounting but also reduced craving, indicating that while SRI can heighten the perceived value of immediate rewards, it may also help in managing cravings when combined with EFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. Ruhi-Williams, P., King, MJ., Stein, JS., et al.[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]

Citations

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Smoking cessation in pregnancy: An update for maternity ... This paper provides an up-to-date summary of the effects of smoking in pregnancy as well as challenges and best practices for supporting smoking cessation ...

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Effectiveness of smoking cessation interventions among ... Non-pharmacological interventions for smoking cessation are the most effective for pregnant women. The moderator analysis suggests that pregnant women of low ...

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Financial Rewards for Smoking Cessation by Low-Income ... The purpose of this study is to test in a clinical prenatal care setting the effectiveness of the Smoke-Free Moms intervention that provides pregnant women a ...

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Smoke-free homes: The final frontier SHS exposure during pregnancy can cause pregnancy complications, a modest reduction in birth weight, preterm delivery, stillbirths, and infant deaths. Level of ...

5. nature.com nature.com/articles/s41598-017-08922-x

mHealth Intervention is Effective in Creating Smoke-Free ... The primary outcomes of the study were self-reported smoking status among the fathers and self-reported SHS exposure at home among the mothers ...

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Smoking cessation interventions for pregnant women ... This updated review aimed to identify and measure the efficacy of smoking cessation interventions trialled among pregnant women in AOD treatment settings who ...

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Smoking cessation in pregnant women: A randomized ... Overall, the results of the current study imply that eHealth intervention was not effective in reducing smoking behavior and perceived stress. However, findings ...

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Smoking Cessation 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 ...

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Tobacco and Nicotine Cessation During Pregnancy Pregnancy influences many women to stop smoking, and approximately 54% of women who smoke before pregnancy quit smoking directly before or during pregnancy.

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Digitalizing Specialist Smoking Cessation Support in Pregnancy This study explored pregnant smokers' perceptions of barriers and facilitators to using digital cessation support, along with identifying modes of delivery and ...