Telephone Intervention for Pregnant Smokers: A Randomized Controlled Trial

doi:10.1016/j.amepre.2016.02.022

American Journal of Preventive Medicine

Volume 51, Issue 3, September 2016, Pages 318-326

https://doi.org/10.1016/j.amepre.2016.02.022 Get rights and content

Introduction

Pregnant smokers are advised to quit; however, many struggle to do so. Behavioral counseling can increase quitting success, but the efficacy of telephone counseling for pregnant smokers has not been established. This study tests the efficacy of pregnancy-specific counseling, embedded in the ongoing operations of a state quitline.

Design

In this two-group RCT, participants were randomly assigned to the intervention (telephone counseling plus self-help materials, n=584) or the control group (self-help materials only, n=589).

Setting/participants

Participants were pregnant smokers (N=1,173) in the first 27 weeks of gestation who called a state quitline between September 2000 and May 2003 for help with quitting.

Intervention

The primary component of the intervention was telephone counseling using a semi-structured protocol developed specifically for pregnant smokers. It drew its basic structure and clinical content from a previously tested counseling protocol for adult quitline callers, while including pregnancy-specific content and additional counseling sessions (nine rather than the standard five).

Main outcome measures

Subjects were evaluated on prolonged abstinence at the third trimester (about 29 weeks’ gestation) and at 2 and 6 months postpartum. Data were analyzed in 2015.

Results

Abstinence was higher for the intervention than the control group at the end of pregnancy (30-day abstinence, 29.6% vs 20.1%; p<0.001); 2 months postpartum (90-day abstinence, 22.1% vs 14.8%; p<0.001); and 6 months postpartum (180-day abstinence, 14.4% vs 8.2%; p<0.001). Cotinine-corrected (≤13 ng/mL) 7-day abstinence rates at the end of pregnancy supported the intervention effect (35.8% vs 22.5%, p<0.001).

Conclusions

A pregnancy-specific counseling protocol, embedded in a state quitline, was effective in helping pregnant smokers quit and stay quit postpartum. Wide adoption of this intervention could help reduce the rate of maternal smoking and prevent its devastating health consequences.

Trial Registration

This study is registered at www.clinicaltrials.gov NCT02144883.

Introduction

Pregnant women are advised to refrain from behaviors potentially harmful to their health or to the health of their baby, such as using alcohol, taking certain medications, and smoking.1, 2 The Surgeon General’s report states that smoking during pregnancy increases the risk of pregnancy complications, premature delivery, low birth weight infants, stillbirth, and sudden infant death syndrome.³ Many pregnant smokers heed the advice to quit and quit smoking as soon as they find out they are pregnant.⁴ Yet, more than half of pregnant smokers (52.5%–56.1%) continue to smoke throughout pregnancy.⁵ Many want to quit, but struggle to do so. Despite 20 years of research, ways to help pregnant smokers quit remain limited.6, 7 Nicotine-replacement therapy has been proposed as a possible approach,8, 9, 10 with some calling for higher dosing owing to faster nicotine metabolism during pregnancy.¹¹ However, pharmacotherapy is controversial because of its potential to harm the fetus12, 13, 14, 15 and lack of evidence of effectiveness for pregnant smokers.13, 16 Limitations on use of pharmacotherapy increase the importance of behavioral counseling for this population.

There have been many randomized trials of cessation interventions for pregnant women, most using behavioral counseling alone or in combination with incentives, support partners, videos, or hypnosis. Overall, participants who received interventions were more likely to be abstinent at the end of the pregnancy (risk ratio [RR]=1.44, 95% CI=1.19, 1.75) than those in the control groups.⁶ They were also less likely to have a low birth weight child (RR=0.83, 95% CI=0.73, 0.95) or preterm birth (RR=0.86, 95% CI=0.74, 0.98) than those in the control groups.⁷ The most effective behavioral intervention was offering financial incentives. Intensity and theoretic underpinnings of interventions did not lead to significant differences in efficacy. However, modality of behavioral intervention did play a role. In-person interventions, either one-on-one or group, were effective. Only two17, 18 of 11 studies of telephone intervention resulted in significant effects, one also offered financial incentives in the form of a lottery and the other was significant at the end of pregnancy, but not at 6 months postpartum.

It is somewhat surprising that telephone counseling was not more successful given that smoking-cessation “quitlines” have become a staple of tobacco control.19, 20 Quitlines are easy to access, have broad appeal, and a strong research basis.19, 20 The convenience of telephone-based counseling has long been a key factor in attracting smokers who seek behavioral treatment.¹⁹ Quitlines would seem to be an ideal way to reach pregnant smokers.21, 22, 23 More than 90% of U.S. quitlines reported that they provide specialized materials for pregnant smokers and additional training for counselors on how to help them quit.²⁴ However, no study has yet documented an empirically validated pregnancy-specific telephone counseling protocol, effective into postpartum.

This paper presents findings from an RCT testing the efficacy of a pregnancy-specific counseling protocol, embedded in the ongoing operations of a state quitline. The study tested two hypotheses: (1) that telephone counseling would increase the cessation rate during pregnancy and (2) that the difference between the intervention and control groups would be maintained postpartum.

Section snippets

Design and Allocation Strategy

The trial used a two-group design. Subjects were stratified by whether they were current smokers (97.4%) or recent quitters (2.6%) and randomly assigned (1:1) to the intervention (n=584) or control condition (n=589). A power calculation indicated that 602 subjects per group would provide power of 0.80 with an α-level of 0.05 to detect an increase in the continuous abstinence rate from 8% to 16% counting subjects not reached for evaluation as smokers. Random allocation to condition was done by

Results

Table 1 shows the equivalence of randomized conditions on individual characteristics at baseline. About 47% were aged 18–24 years and nearly two thirds had a high school education or less. There was considerable ethnic diversity: More than 40% were ethnic minorities with high representation of African Americans (21%) and Hispanic/Latinos (13%). Only 31% of women had private health insurance, another 53% had insurance through Medicaid, and 15% had no health insurance. Less than 50% of these

Discussion

This is the first RCT to demonstrate that a telephone-based, pregnancy-specific protocol without financial incentives can increase smoking cessation during pregnancy, with a sustained effect in the postpartum period. The protocol was designed to promote quit attempts and prevent relapse. The study indicated that the primary impact of the intervention was to prevent relapse. The effect was maintained up to 6 months postpartum.

At the end of pregnancy, women in the intervention condition were 1.5

Conclusions

This study is the first to establish that telephone counseling without the use of financial incentives can be effective in helping pregnant smokers quit and stay quit postpartum. These results should spur more studies to replicate, and perhaps extend, research in this area. In previous studies of telephone counseling, counseling impacted cessation through two mechanisms.29, 30 First, it increased the proportion of smokers who made a quit attempt. Second, it increased the proportion of smokers

Acknowledgments

The authors wish to thank Nicole Howard and Phyllis Hartigan for input on the protocol, Mary Burke and Jasmine Reyes-Nocon for managing data collection, Carrie Kirby for project management, and the counselors so dedicated to this effort.

This research was supported by the Tobacco-Related Disease Research Program (Grant 8RT-0103) and First 5 California (Contract CCFC-6810) and by funds received from the California Department of Health Services Tobacco Control Section (Contract 00–90605). The

References (36)

S. Wong et al.
Substance use in pregnancy
J Obstet Gynaecol Can
(2011)
K.I. Pollak et al.
Nicotine replacement and behavioral therapy for smoking cessation in pregnancy
Am J Prev Med
(2007)
L.S. Brose et al.
Association between nicotine replacement therapy use in pregnancy and smoking cessation
Drug Alcohol Depend
(2013)
T.A. Slotkin
If nicotine is a developmental neurotoxicant in animal studies, dare we recommend nicotine replacement therapy in pregnant women and adolescents?
Neurotoxicol Teratol
(2008)
E.A. Dornelas et al.
Efficacy and cost-effectiveness of a clinic-based counseling intervention tested in an ethnically diverse sample of pregnant smokers
Patient Educ Couns
(2006)
VA/DoD Clinical Practice Guideline for Management of Pregnancy
(2009)
U.S. Office of the Surgeon General, Office on Smoking and Health. The Health Consequences of Smoking: A Report of the...
L.J. Solomon et al.
Spontaneous quitting: self-initiated smoking cessation in early pregnancy
Nicotine Tob Res
(2004)
V.T. Tong et al.
CDC. Trends in smoking before, during, and after pregnancy—Pregnancy Risk Assessment Monitoring System (PRAMS), United States, 31 sites, 2000-2005
MMWR Surveill Summ
(2009)
C. Chamberlain et al.
Psychosocial interventions for supporting women to stop smoking in pregnancy
Cochrane Database Syst Rev
(2013)

J. Lumley et al.

Interventions for promoting smoking cessation during pregnancy

Cochrane Database Syst Rev

(2009)

N.L. Benowitz et al.

Pharmacotherapy for smoking cessation during pregnancy

Nicotine Tob Res

(2004)

D. Dempsey et al.

Accelerated metabolism of nicotine and cotinine in pregnant smokers

J Pharmacol Exp Ther

(2002)

J.E. Bruin et al.

Long-term consequences of fetal and neonatal nicotine exposure: a critical review

Toxicol Sci

(2010)

T. Coleman et al.

Pharmacological interventions for promoting smoking cessation during pregnancy

Cochrane Database Syst Rev

(2012)

D.R. Schroeder et al.

Nicotine patch use in pregnant smokers: smoking abstinence and delivery outcomes

J Matern Fetal Neonatal Med

(2002)

I. Berlin et al.

Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

BMJ

(2014)

P. Nowicki et al.

Effective smoking intervention during pregnancy

Birth

(1984)

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Breastfeeding duration is positively associated with decreased smoking relapse in the postpartum period
2022, Midwifery
A significant proportion of women quit smoking during pregnancy, creating a unique window of opportunity to encourage long-term smoking cessation. Efforts to prevent smoking relapse in the postpartum period, however, have largely been ineffective. We investigated the association between breastfeeding duration and smoking relapse to help inform postpartum smoking cessation strategies.
The Ulm SPATZ Health Study consists of 1006 newborns and their 970 mothers recruited from April 2012 to May 2013 in Ulm, Germany. For this analysis, only mothers who quit smoking during pregnancy, for whom breastfeeding and smoking data were available, were included. Kaplan-Meier plots were used to investigate the relationship between breastfeeding duration and postpartum smoking relapse within 2 years. Cox proportional hazards regression models were used to estimate hazard ratios, adjusted for factors reported to influence postpartum smoking outcomes.
A total of 115 mothers were included. They had a mean age of 32.0 (SD: 5.0) years and breastfed for 5.6 (SD: 4.4) months. Of those who remained in the study, 14 (12.2%) experienced smoking relapse by 6 weeks and 48 (51.1%) relapsed by 2 years. In an adjusted analysis which accounted for age, educational attainment, postpartum weight retention, and gestational weight gain, breastfeeding for at least 6 months was significantly associated with decreased smoking relapse within 2 years (HR: 0.18; 95% CI: 0.07 - 0.45).
Breastfeeding for at least 6 months was associated with decreased postpartum smoking relapse. Breastfeeding promotion should be considered to enhance smoking cessation strategies in the postpartum period.
A systematic review of behaviour change techniques within interventions to prevent return to smoking postpartum
2019, Addictive Behaviors
Citation Excerpt :
The number of BCTs identified in individual interventions ranged from one to 19, with an average of 7.7 BCTs per intervention. Focusing only on long-term effective interventions,(Brandon et al., 2012; Cummins et al., 2016; Hannover et al., 2009; McBride et al., 1999; Mullen et al., 2001; Reitzel et al., 2010) the number of BCTs identified ranged from five to 19 with an average of 11 BCTs per intervention. The most prevalent BCTs in all included trials (coded in ≥25% interventions) were: ‘problem solving’ (n=27); ‘information about social and environmental consequences' (n=27); ‘social support (unspecified)’ (n = 25); ‘information about health consequences' (n = 18); ‘credible source’ (n = 17); ‘instruction on how to perform a behaviour’ (n = 11); and ‘reduce negative emotions' (n = 9).
There is no routine support to prevent postpartum smoking relapse, due to lack of effective interventions. Previous reviews have identified behaviour change techniques (BCTs) within pregnancy cessation trials to specify which components might be incorporated into more effective interventions, but no reviews have identified BCTs for prevention of smoking relapse postpartum. We reviewed BCTs and potential delivery modes, to inform future interventions.
We searched Medline and EMBASE from January 2015–May 2017; and identified trials published before 2015 by handsearching systematic reviews. We included RCTs where: i) ≥1 intervention component aimed to maintain smoking abstinence versus a less intensive intervention; ii) participants included pregnant or postpartum smoking quitters; iii) smoking status was reported in the postpartum period. We extracted trial characteristics and used the Behaviour Change Technique Taxonomy v1 to extract BCTs. We aimed to identify ‘promising’ BCTs i.e. those frequently occurring and present in ≥2 trials that demonstrated long-term effectiveness (≥6 months postpartum). Data synthesis was narrative.
We included 32 trials, six of which demonstrated long-term effectiveness. These six trials used self-help, mainly in conjunction with counselling, and were largely delivered remotely. We identified six BCTs as promising: ‘problem solving’, ‘information about health consequences’, ‘information about social and environmental consequences’, ‘social support’, ‘reduce negative emotions’ and ‘instruction on how to perform a behaviour’.
Future interventions to prevent postpartum smoking relapse might include these six BCTs to maximise effectiveness. Tailored self-help approaches, with/without counselling, may be favourable modes of delivery of BCTs.
Registration: PROSPERO CRD42018075677.
Explaining school entry math and reading achievement in Canadian children using the Opportunity-Propensity framework
2019, Learning and Instruction
The Opportunity–Propensity framework predicts that academic success is a function of: (a) Antecedent; (b) Opportunity; and (c) Propensity factors. The aim of the present study was to replicate and expand the O-P framework model with a population-based representative sample of French-Canadian children. The sample consisted of 2120 children followed in the context of the Quebec Longitudinal Study of Child Development (QLSCD). Structural equation models revealed that the O-P framework provided a good fit to the Canadian data and predicted 55 and 51% of the variance in kindergarten math and verbal achievement, respectively. Furthermore, the addition of previously unexamined antecedent (i.e., gestational smoking), opportunity (i.e., home literacy activities), and propensity (i.e., motor skills) predictors contributed significant variance to the model. Similarities and differences between the Canadian findings and those obtained with American samples are discussed in terms of social policy and intervention programs.
Medi-Cal Incentives to Quit Smoking Program: Reach to Pregnant and Parenting Women
2018, American Journal of Preventive Medicine
Citation Excerpt :
In addition, an evaluation of the TIPS 2012 campaign found an association with increased smoking cessation among pregnant women.20 Specific to telephone counseling in California, results from an RCT showed that pregnant women who used Helpline counseling were 1.5 times more likely to quit smoking by the third trimester and 1.7 times more likely to be smoke free at 6 months postpartum, compared with a self-help materials group.19 The percentage of the population reached for women of reproductive age and pregnant women during the MIQS incentive period was slightly higher than the percentage before MIQS.
In California, half of pregnant women and children are on California's Medicaid (Medi-Cal). The Medi-Cal Incentives to Quit Smoking program provided incentives to adults on Medi-Cal to call the California Smokers Helpline (Helpline) from March 2012 to July 2015. This analysis examined reach of the Medi-Cal Incentives to Quit Smoking program among pregnant and parenting women.
This study examined caller data from the Helpline from 2010 to 2015 among women of reproductive age (18–45 years) enrolled in Medi-Cal (n=32,691; analyzed in 2017/2018). The authors calculated the annual percentage of the target population reached who called the Helpline by pregnancy status and used adjusted prevalence ratios to examine the associations between Medi-Cal Incentives to Quit Smoking incentive period, pregnancy/parenting status, Medi-Cal Incentives to Quit Smoking incentives ($20 gift card and nicotine patch), and counseling.
Over the study period, the percentage of the target population reached increased for women of reproductive age (2.1% in 2011 to 3.0% in 2014) and pregnant women (2.1% in 2011 to 3.3% in 2014). The percentage of women who asked for the $20 gift card (13.6%) was not substantially different by pregnancy status, and WIC and nonprofits were important referral sources. Pregnant women were less likely to receive nicotine patches, but there was a 3- to 4-fold increase during the Medi-Cal Incentives to Quit Smoking incentive period for both pregnant and nonpregnant women. Among nonpregnant women, counseling decreased 14% during the Medi-Cal Incentives to Quit Smoking incentive period.
Results suggest that the nicotine patch incentives motivated women to call the Helpline, even pregnant women who needed a physician's approval consistent with current American College of Obstetricians and Gynecologists cautions about the appropriateness of the patch during pregnancy.
This article is part of a supplement entitled Advancing Smoking Cessation in California's Medicaid Population, which is sponsored by the California Department of Public Health.
A Randomized Trial of Text Messaging for Smoking Cessation in Pregnant Women
2017, American Journal of Preventive Medicine
Citation Excerpt :
An additional strength of this study is the inclusion of biochemical confirmation of smoking status. The decision to confirm smoking status biochemically was made because of the high deception rate documented in previous studies of pregnant smokers.11,13,50 Indeed in this study, of those who returned the saliva samples, 35.29% were found to have discrepancies between their self-report on the 3-month survey and cotinine levels, though discrepancies resulted in similar reductions in quit rates in both groups.
There is a need for innovation in both the enrollment of pregnant smokers in smoking cessation treatment programs and in the types of treatments offered. The study tests whether an interactive and intensive text messaging program, Quit4baby, can promote smoking cessation for pregnant women already enrolled in a health text messaging program, Text4baby.
Between July 2015 and February 2016, a total of 35,957 recruitment text messages were sent to Text4baby subscribers. Eligible pregnant smokers were enrolled and randomized to receive Text4baby (control) or Text4baby and Quit4baby (intervention; N=497). Participants were surveyed at 1 month, 3 months, and 6 months post-enrollment, and saliva samples were collected at 3 months for biochemical verification of smoking status. Data were collected from 2015 to 2016 and analyzed in 2016.
Using an intention-to-treat analysis, 28.80% of the intervention group and 15.79% of the control group reported not smoking in the past 7 days at 1 month (p<0.01), and 35.20% of the intervention group and 22.67% of the control group reported not smoking in the past 7 days at 3 months (p<0.01). Biochemical verification of smoking status at 3 months indicated no significant differences between groups (15.60% in the intervention group and 10.93% in the control group [p=0.13]), although significant differences favoring the intervention were found for older smokers (p<0.05) and for those who enrolled in their second or third trimester of pregnancy (p<0.05). Self-report of late pregnancy 7- and 30-day point prevalence abstinence favored the intervention group (p<0.001, p<0.01). No significant differences were observed at the 6-month follow-up or in the postpartum period.
Results provide limited support of the efficacy of the Quit4baby text messaging program in the short term and late in pregnancy, but not in the postpartum period.
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Research ArticleTelephone Intervention for Pregnant Smokers: A Randomized Controlled Trial

Introduction

Design

Setting/participants

Intervention

Main outcome measures

Results

Conclusions

Trial Registration

Introduction

Section snippets

Design and Allocation Strategy

Results

Discussion

Conclusions

Acknowledgments

J Obstet Gynaecol Can

Am J Prev Med

Drug Alcohol Depend

Neurotoxicol Teratol

Patient Educ Couns

VA/DoD Clinical Practice Guideline for Management of Pregnancy

Spontaneous quitting: self-initiated smoking cessation in early pregnancy

Nicotine Tob Res

CDC. Trends in smoking before, during, and after pregnancy—Pregnancy Risk Assessment Monitoring System (PRAMS), United States, 31 sites, 2000-2005

MMWR Surveill Summ

Psychosocial interventions for supporting women to stop smoking in pregnancy

Cochrane Database Syst Rev

Interventions for promoting smoking cessation during pregnancy

Cochrane Database Syst Rev

Pharmacotherapy for smoking cessation during pregnancy

Nicotine Tob Res

Accelerated metabolism of nicotine and cotinine in pregnant smokers

J Pharmacol Exp Ther

Long-term consequences of fetal and neonatal nicotine exposure: a critical review

Toxicol Sci

Pharmacological interventions for promoting smoking cessation during pregnancy

Cochrane Database Syst Rev

Nicotine patch use in pregnant smokers: smoking abstinence and delivery outcomes

J Matern Fetal Neonatal Med

Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

BMJ

Effective smoking intervention during pregnancy

Birth

Research Article
Telephone Intervention for Pregnant Smokers: A Randomized Controlled Trial