Smoking Cessation Program During Pregnancy for Childhood Obesity Prevention

Overseen By Xiaozhong Wen, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Cancer, Heart disease, Depression, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it focuses on smoking cessation, so it might be best to discuss your medications with the trial coordinators.

Is the multicomponent behavioral intervention for smoking cessation safe for humans?

The multicomponent behavioral intervention for smoking cessation, which includes education, counseling, and financial incentives, has been used safely in pregnant women to help them quit smoking. Participants in these programs have reported positive experiences, and no safety concerns have been highlighted in the studies. ^{1 2 3 4 5}

How is the multicomponent behavioral intervention treatment for smoking cessation during pregnancy different from other treatments?

The multicomponent behavioral intervention for smoking cessation during pregnancy is unique because it combines various strategies like counseling, possibly with mobile technology support, to help pregnant women quit smoking, which is different from single-method approaches like nicotine replacement or hypnosis. ^{4 6 7 8 9}

What data supports the effectiveness of this treatment for smoking cessation during pregnancy?

Research shows that multicomponent interventions, which combine behavioral and pharmacological support, are more effective for quitting smoking than using just one type of therapy. Additionally, behavioral support has been found to help pregnant women stop smoking, although the specific techniques that work best are still being studied. ^{1 2 4 10 11}

Who Is on the Research Team?

Xiaozhong Wen, MD, PhD

Principal Investigator

State University of New York at Buffalo

Are You a Good Fit for This Trial?

This trial is for English-speaking pregnant women aged 18-39, who smoke cigarettes, are less than 20 weeks pregnant with a single baby, and have low income or education. They must live in Erie or Niagara County and be willing to quit smoking using behavioral interventions and provide samples to confirm their smoking status. Women with major chronic diseases, blood clotting disorders, depression or other mental health conditions that could interfere with the study are not eligible.

Inclusion Criteria

Singleton pregnancy

Currently smoking one or more cigarettes per day, based on self-report

Currently smoking biochemically verified by a level of 1 or higher in urine cotinine test (>100ng/mL cotinine concentration)

Exclusion Criteria

I have a history of major illnesses like cancer or heart disease.

I have been diagnosed with depression, including post-partum depression.

I am receiving treatment for a mental health disorder that makes it hard for me to quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Pregnancy

Participants receive a multicomponent intervention or education-only control during pregnancy to promote smoking cessation

35 weeks

Regular visits throughout pregnancy

Treatment - Lactation

Successful quitters from pregnancy phase receive continued intervention or education-only control during lactation

6 months postpartum

Follow-up visits during lactation period

Follow-up

Participants are monitored for smoking abstinence and infant weight-for-length z-score gain

6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Education only control
• Multicomponent behavioral intervention

Trial Overview The study tests if quitting smoking during pregnancy or lactation can prevent rapid weight gain in infants. It involves two phases: first comparing a multicomponent intervention (education, counseling, monitoring/feedback, financial incentives) against an education-only control during pregnancy; then among those who quit successfully by end of pregnancy further randomization into continuous intervention or control during lactation.

How Is the Trial Designed?

Group I: Multicomponent behavioral intervention Experimental Treatment 1 Intervention

The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support.

Group II: Control Active Control 1 Intervention

The control group will receive smoking cessation education only.

Multicomponent behavioral intervention is already approved in United States, European Union for the following indications:

Approved in United States as Multicomponent behavioral intervention for:

• Smoking cessation in pregnancy
• Prevention of pediatric obesity

Approved in European Union as Multicomponent behavioral intervention for:

• Smoking cessation in pregnancy
• Prevention of pediatric obesity

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Published Research Related to This Trial

In a residential smoking cessation program involving 43 smokers, 72% achieved abstinence by the time they were discharged, indicating high initial success rates.

At the two-month follow-up, 55% of participants remained abstinent, and 53% maintained abstinence at the six-month mark, suggesting that the program has lasting effects on smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description and evaluation of the smoking cessation component of a multiple risk factor intervention program. Malotte, CK., Fielding, JE., Danaher, BG.[2019]

Multicomponent interventions that combine behavioral and pharmacological strategies are more effective for smoking cessation than single-type therapies, leading to higher rates of abstinence.

The review presents flexible intervention models that can be adapted for different clinical settings and patient needs, allowing clinicians to tailor smoking cessation programs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation 3: multicomponent interventions. Cofta-Woerpel, L., Wright, KL., Wetter, DW.[2015]

A controlled smoking treatment case study showed an impressive 85% reduction in cigarette smoking over a 30-month follow-up period, indicating high efficacy of the multicomponent behavioral interventions used.

The study found no compensatory changes in smoking behavior, suggesting that the treatment effectively maintained long-term smoking reduction without leading to other unhealthy habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled smoking: single case study with multicomponent intervention. Baldwin, S., Heather, N.[2019]

Effective behavioral support interventions for pregnant smokers included an average of 8 behavior change techniques (BCTs), with 11 techniques being common across multiple successful interventions.

Despite the identification of effective BCTs, only 15.4% of English Stop Smoking Services treatment manuals included all 11 techniques, indicating a gap between research and practice in smoking cessation support for pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specifying evidence-based behavior change techniques to aid smoking cessation in pregnancy. Lorencatto, F., West, R., Michie, S.[2022]

A hospital-based smoking cessation program that included behavioral counseling and support was effective, achieving a 32% abstinence rate at 12 months among participants who attended at least two sessions.

Factors such as self-belief in quitting, having a heart condition, and not growing up with smoking siblings were linked to higher chances of long-term abstinence, highlighting the importance of social and psychological influences in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of hospital-based smoking cessation. Fung, PR., Snape-Jenkinson, SL., Godfrey, MT., et al.[2019]

In a study involving 1402 pregnant smokers, the Loma Linda University Health Comprehensive Tobacco Treatment Program achieved an 8-week prolonged abstinence rate of 28.4%, indicating the program's effectiveness in helping pregnant women quit smoking.

Follow-up data revealed that 23.2% of participants maintained tobacco cessation at a median of 6.2 months after achieving initial abstinence, although there was a significant loss to follow-up (44%), highlighting challenges in sustaining engagement in cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Outcomes of a Maternal Smoking Cessation Program for a Multi-ethnic Cohort in California, USA, 2012-2019. Petersen, AB., Ogunrinu, T., Wallace, S., et al.[2023]

A pilot study involving 48 pregnant women who smoke showed that a multicomponent behavioral intervention, including financial incentives, education, and counseling, led to a 70% smoking cessation rate within two weeks and 63.3% by the end of the 8-week program.

The intervention was well-received, with 85.7% of participants meeting or exceeding their expectations, and 100% recommending the program, indicating its feasibility and acceptability for helping pregnant women quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral intervention for smoking cessation during pregnancy: a nonconcurrent multiple-baseline design. Wen, X., Eiden, RD., Justicia-Linde, FE., et al.[2020]

The high intensity smoking cessation intervention for pregnant women led to a significantly higher quit rate of 45.2% compared to 21.4% in the minimal contact control group, demonstrating its efficacy in promoting smoking cessation during pregnancy.

Participants in the high intensity group also showed significant reductions in urine cotinine and NNAL levels, indicating decreased exposure to tobacco-specific carcinogens, which is beneficial for fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. Loukopoulou, AN., Vardavas, CI., Farmakides, G., et al.[2023]

The Quit4baby text messaging program significantly improved short-term smoking cessation rates among pregnant women, with 28.80% of participants not smoking in the past week at 1 month compared to 15.79% in the control group.

While the intervention showed promise for older smokers and those in their second or third trimester, there were no significant differences in smoking status at the 6-month follow-up or postpartum, indicating limited long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Text Messaging for Smoking Cessation in Pregnant Women. Abroms, LC., Johnson, PR., Leavitt, LE., et al.[2018]

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]

There are currently only a few mHealth programs specifically designed for smoking cessation in pregnant women, with five SMS programs and two mobile apps identified, but they show low enrollment rates.

Evidence supporting the effectiveness of these mHealth programs is limited, highlighting the need for further research to evaluate their efficacy and improve participant engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation support for pregnant women: role of mobile technology. Heminger, CL., Schindler-Ruwisch, JM., Abroms, LC.[2022]

Citations

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

Description and evaluation of the smoking cessation component of a multiple risk factor intervention program. [2019]

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

Smoking cessation 3: multicomponent interventions. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Controlled smoking: single case study with multicomponent intervention. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Specifying evidence-based behavior change techniques to aid smoking cessation in pregnancy. [2022]

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

Effectiveness of hospital-based smoking cessation. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation and Outcomes of a Maternal Smoking Cessation Program for a Multi-ethnic Cohort in California, USA, 2012-2019. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral intervention for smoking cessation during pregnancy: a nonconcurrent multiple-baseline design. [2020]

8. Greece pubmed.ncbi.nlm.nih.gov

Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Text Messaging for Smoking Cessation in Pregnant Women. [2018]

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

Successful interventions for smoking cessation in pregnancy. [2019]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Smoking cessation support for pregnant women: role of mobile technology. [2022]