Expecting to Quit: A Best Practices Review of Smoking Cessation Interventions for Pregnant and Postpartum Girls and Women

Results: Smoking Cessation Interventions and Programs for Pregnant/Postpartum Women and Girls

Smoking Cessation Interventions

A total of 58 studies were included in our review, of which 20 showed statistically significant differences in smoking cessation outcomes between treatment and control groups. Based on evidence of their effectiveness and methodological strength (see page 26), six interventions were recommended, and 14 interventions were classified as "showing promise." These interventions are listed in Tables 4.1 and 4.2 below. Program materials with no available evaluation data are considered separately in Section 4f (see page 38).

Of the interventions listed in Tables 4.1 and 4.2 below, approximately 14 interventions were tested in the 'general' pregnant smoking population and 10 were tested in pregnant sub-populations, including ethnic minorities, women of low socioeconomic status, and teenaged girls. Results for each of these pregnant groups are discussed separately in Sections 4c through 4f below. A summary of the details of our review of each intervention can be found in Appendices 8b and 8c. Please refer to Table 4.3 and Figure 4.1 for a detailed description of the numbers of studies that were inlcuded and eliminated from the review.

Table 4.1 Effective Interventions and Programs
Table 4.2 Ineffective Interventions and Programs

Methodological Limitations

There are several methodological limitations in the studies that have been reviewed so far. The studies often vary on the definitions of "smoker and nonsmoker" utilized, creating a lack of precision and lack of comparability among studies. There are also differences in the approaches taken to the issue of spontaneous quitting. Some studies measure spontaneous quitting, and some do not. Therefore, assessing whether the quit rates during pregnancy are due to the intervention or are independent of the intervention is sometimes difficult. Another issue concerns those women who drop out of the study. Are these women counted as smokers or not? We found that this aspect was not always clear in the studies we reviewed, but if such women are not counted as smokers, this could have a significant effect on the absolute rates of cessation reported in the studies.

Many tobacco cessation interventions for pregnant smokers are deliberately tailored to meet the perceived needs of pregnant women. A tailoring process is commonly used in many of the interventions, but is often not defined or explained in any useful detail and the criteria for tailoring components of interventions remain obscure. So while tailoring is clearly an important component of cessation interventions, the precise nature of the tailoring, and the theoretical context in which it is done, is often difficult to identify.

There is also the general issue of effectiveness and efficacy. Interventions may be valid and supported in research settings but fail the test of "real-world" applicability. This issue is difficult to assess in reviewing the literature on interventions at the best of times, but is exacerbated by little discussion of applicability issues and little description of how programs are applied or delivered. For example, some studies report assessments of clinical efficacy and adherence to clinical protocols, but the wider assessment of whether or not the intervention would pass the "real-world" test is often left undone.

Assessment of program materials is hampered by the general lack of evaluation data and, where available, inconsistent evaluation data. This is particularly troublesome when attempting to establish Better Practices as many programs and program materials exist or are adapted in real-life situations across Canada, but suffer from a lack of research and evaluation. In some cases, we found that components of an intervention study were such program materials, but again, the effects of the program material component were not often assessed separately from the whole intervention, contributing further to a lack of clarity about the effects of program materials. A final problem is the lack of an updated general registry of such programs for both clinical and research purposes.

The most significant overall methodological concern is over the specific roles of various components in the interventions, and how they are difficult to assess independently. Most interventions contain several elements or components. As the field of tobacco cessation for pregnant smokers has evolved and expanded, multi-component programs appear to have become the rule rather than the exception. However, the various components are often not tested independently, so their impact in these interventions is difficult to assess.

Interventions Aimed at the Pregnant Population, including Heavy Smokers and Teenaged Girls

Both successful and unsuccessful interventions targeted at pregnant smokers involved multiple components, but in most cases, the effectiveness of individual components was not tested. It is therefore not possible to recommend with certainty any particular intervention components as efficacious. However, some components appear repeatedly in successful interventions for pregnant smokers, notably tailored information in the form of a self-help guide. Self-help guides may be important for supporting cessation efforts in the "general" pregnant smoker population.

The pregnant population is not a uniform target group. In addition to socio-economic and cultural differences among pregnant smokers, considered in Section 4e, women vary considerably in the amount of nicotine they use. Heavy smokers, defined as those women who smoke 10 or more cigarettes per day during their pregnancies, and women who quit spontaneously early in their pregnancies obviously require different types of clinical support during cessation/maintenance attempts. Yet each group is often subsumed under the general heading of pregnant smoker. Although in many studies they are treated separately in statistical analyses, the degree to which interventions are tailored to meet their specific needs is unknown.

Comparatively little attention has been directed exclusively towards spontaneous quitters; and none of the six studies we reviewed which provided an intervention to this population showed any significant effects. Various combinations of standard health information, tailored information, counselling, social support, and tailored biological feedback were tested (Ershoff, Quinn, & Mullen, 1995; Lowe, Windsor, Balanda, & Woodby, 1997; McBride et al., 1999; Hajek et al., 2001; Secker-Walker, Mead et al., 1995; Secker-Walker, Solomon, Flynn, Skelly, & Mead, 1998). Based on our methodology and the evidence to date, it is possible to say that a combination of social support and counselling, as tested by Lowe et al (1997) is ineffective in helping women who had quit in early pregnancy maintain their abstinence. Further exploration in this area is desperately needed, given that a significant proportion of women who quit during their pregnancies are smoking again soon thereafter (Lowe et al., 1997).

Women smoking more than 10 cigarettes per day, even late into their pregnancies, also represent a distinct target for tailored smoking cessation interventions. Again, interventions specifically targeting women in this group are lacking, but several strategies have been tested in this area. One intervention, using a self-help guide (Valbo and Schioldborg,1994) shows promise. Nicotine replacement therapies have been tested almost exclusively in this population (see Section 4d), but to date no studies allow us to comment definitively on their utility. From a harm reduction perspective, the use of NRT to facilitate smoking cessation late in pregnancy in heavy smokers may be especially advantageous.

Very few studies exist that specifically target smoking cessation among pregnant teens, and no studies met our methodological and outcome criteria upon which a recommendation could be based. Indeed, few cessation programs exist for adolescents in general, the majority of smoking interventions for this age group being school-based initiatives to prevent initiation. It is unlikely that cessation strategies for pregnant women can be applied directly to pregnant teens, given their vastly different contextual environments and life circumstances. Components of teen cessation interventions have included group information sessions, one to one counselling from a nurse, and buddy support from a non-smoking female peer. However, there is no indication that they are more effective than usual care in achieving cessation. Given the abundance of literature to suggest that peer influence is a major predictor of smoking behavior among teenaged girls, strategies that incorporate a peer support component may warrant further investigation.

Pharmacological Interventions for Pregnant Smokers

While the efficacy of pharmacological interventions including the use of NRTs and other drugs such as Bupropion (Zyban) is well established in adult populations, there is no clear evidence of the efficacy of these interventions to assist pregnant women who smoke. In non-pregnant smokers, when used as directed, NRTs in any form and Bupropion are generally safe. Studies have demonstrated that the use of pharmacological interventions can increase successful quit rates as much as twofold (Benowitz et al., 2000). These drugs are used to help minimize withdrawal symptoms, although the mechanism of Bupropion's effect is not well understood. While men and women appear to quit smoking at similar rates, women may experience more withdrawal symptoms than men do. There has been some suggestion that NRT is more effective in men than in women (Okuyemi, Ahluwalia, & Harris, 2000).

There is beginning research that examines the use of pharmacological interventions during pregnancy. Almost no efficacy research related to the use of NRT by pregnant women has been conducted. The research that has been conducted suggests that, while fetal growth is not adversely affected by the use of the nicotine patch (Schroeder et al., 2002; Wisborg, Henriksen, Jespersen, & Secher, 2000), its use does not appear to improve cessation rates (Ogburn et al., 1999; Wisborg, et al., 2000; Wright et al., 1997). The level of nicotine to which the fetus is exposed with the patch or gum has been demonstrated to be lower than that from cigarettes (Benowitz et al., 2000; Oncken, Pbert, Ockene, Zapka, & Stoddard, 2000). There is a clear need for efficacy trials of NRT as adjuvant therapy for smoking cessation during pregnancy. Based on the state of research in the field the following recommendations can be made:

1. Behavioural therapy should be encouraged before pharmacological intervention. It is preferable to have women quit on their own. Therapies such as NRT and Bupropion have potential side effects and these should be explained to the woman.
2. NRT should be used with women who are unable to quit during pregnancy. It has been suggested that intermittent formulations of NRT (such as NRT gum) might be preferable in that these formulations minimize the harm the constant exposure to nicotine might cause the fetus (Benowitz et al., 2000; Dempsey & Benowitz, 2001). Some have suggested that the patch should be discontinued during sleeping hours so that nicotine levels at night might be no higher that they would be with regular smoking (Hackman, Kapur, & Koren, 1999).
3. There are currently no data available on the use of Bupropion during pregnancy. Research on animals suggests that there are no risks, but these findings have not yet been confirmed in humans. Currently, clinicians suggest that Bupropion can be used with pregnant smokers (Okuyemi et al., 2000).
4. Minimal amounts of nicotine are excreted into breast milk (Dempsey and Benowitz, 2001). Continued smoking and use of NRT are not contraindications for breastfeeding.

Smoking Cessation Interventions for Pregnant Sub-populations (Ethnic Groups, Low SES women)

While there have been many interventions in which low-income and minority women are the population under study, it is not always clear whether the intervention has been specifically tailored to meet the needs of these sub-populations. An important distinction can be made between for whom an intervention is designed, and to whom the intervention is administered. By virtue of the fact that the determinants of smoking in pregnancy are linked to poverty and low socio-economic status, it should not be surprising that these are the women who comprise the intervention populations. Ideally, best practices should arise from those interventions targeted and administered to low-income and minority sub-populations.

It is difficult to establish the most effective interventions, given the differences seen in study methodologies, intervention components, study populations, and program delivery settings. In the United States, one-quarter of pregnant women receive their prenatal care in health departments, federally funded health initiatives, or academic clinics, and interventions have been targeted to these predominantly low-income sub-groups. Women in these settings have elevated rates of late enrolment for prenatal care, use and abuse of substances other than tobacco, and low literacy. Existing staff are often relied upon to implement the intervention. However, challenges such as competing priorities and limited time to engage in research tasks can have negative repercussions on the intensity and consistency of the intervention provided.

Interventions among socially and economically disadvantaged sub-groups have largely been based on materials and methods originally designed by Windsor and colleagues for use in publicly funded health care settings such as the Women, Infants, and Children (WIC) program in the United States. The intervention builds off of four standard practice behaviours: ask, advise, assist, and arrange. Components of the most recent version of the intervention (Windsor et al., 2000) include a 14-minute video, a self-help manual with a seven-day cessation plan, and a patient-centred counselling session of less than five minutes during which an action plan is prepared.

The transfer of an intervention from one setting to another may reduce its effectiveness if elements are changed or aspects of the materials are culturally inappropriate. For example, the Windsor program was shown to be effective in Birmingham, Alabama (Windsor et al., 1985; Windsor et al., 1993), but not in Baltimore, Maryland (Gielen et al., 1997). However, it is unclear whether this difference was because the women enrolled in Baltimore were a particularly disadvantaged inner-city sub-group, because the intervention used peer counsellors with minimal training rather than trained health educators, or because of some other factor. There is only one Canadian study in the literature based on Windsor's program, undertaken in an antenatal clinic with a diverse socio-economic population, including francophone women. Women in the intervention group were offered the option of a 20-minute counselling session, based on the Windsor guide, with a public health nurse and telephone follow-up. The intervention group had statistically significant higher quit rates at one month after entry (14.9% vs 5%) and at six weeks postpartum (13.8% vs 5.2%) (O'Connor et al., 1992).

The use of appropriate monetary incentives for disadvantaged sub-groups merits further exploration. Donatelle, Prows, Champeau, & Hudson (2000) reviewed the results of several studies, including two meta-analyses on reinforcement, and concluded that they provided compelling evidence that positive reinforcement provides positive behavioural change. In an intervention based in the WIC program (Donatelle et al., 2000) with predominantly white, partnered, low-income women in their early 20s, cessation rates of 32% (versus 9% in the control group) were documented at eight months gestation. Unlike other interventions with relatively trivial rewards, ten $50 vouchers were provided to women who were biochemically confirmed quitters on a monthly basis. Buddy supporters also received vouchers. While there could be concern about the ethics of an intervention based on monetary reward when used among a low-income group, the converse argument is that monetary rewards are empowering for these women. Indeed, it may be viewed as worthy compensation for an extremely difficult task.

Harm reduction may also be an approach to consider for socially and economically disadvantaged pregnant women who cannot or will not quit. It has been well established that women who reduce smoking by 50% during pregnancy give birth to infants with a higher average birthweight than do women who not change their smoking behaviour (Li et al., 1993). Windsor has suggested using a halving of the cotinine level at baseline as a measure of smoking reduction (Windsor et al., 1993). It has been suggested that a correction for weight gain and volume of distribution effects needs to be applied (Selby, 2003, personal communication). Other studies have considered significant reduction as 50% reduction in biochemically validated exposure to tobacco smoke from baseline using saliva cotinine (Gielen et al., 1997; Windsor et al., 1993) or CO (Hartmann, Thorp, Pahel-Short, & Koch, 1996). Reduction has been recommended as a strategy for future studies (Windsor, Boyd, & Orleans, 1998), but should not be exclusively fetus-centred. In addition to the positive effects on the fetus, smoking reduction provides an opportunity to support, encourage, and empower the woman herself.

In summary, despite the consistently high rates of smoking documented among socially and economically disadvantaged sub-populations of pregnant women, few tobacco cessation programs in Canada have been targeted at this group. (See Appendix 8e for a list of programs aimed at Aboriginal women and other sub-groups of women which could potentially be adapted for use with pregnant women.) There is some evidence to suggest that smoking cessation interventions can be effective for these women, but the relative effectiveness of specific components remains unclear. A panel of experts previously reviewing best practices concluded that almost all benefits of brief counselling occur in light to moderate smokers (Melvin, Mullen, Windsor, Whiteside, & Goldenberg, 2000). Minimal contact programs have been documented to be less successful in women of lower SES than those in higher socioeconomic strata. Interventions that target disadvantaged sub-populations of women likely require more intensive and focused interventions with multiple components resulting in a higher "dose" of the intervention. The use of monetary incentives and the inclusion of harm-reduction strategies are promising avenues for further investigation.

Smoking Cessation Interventions/Programs within Substance Abuse Treatment Settings

Of the studies included in our review, only two reported evaluations of smoking cessation interventions that were incorporated into programs for women with substance abuse (Ker, Leischow, Markowitz, & Merikle, 1996; Waller, Zollinger, Saywell, & Kubisty, 1996). Both evaluations were preliminary studies and showed some promising effects. Importantly, these studies suggest that smoking cessation interventions that are carefully tailored for substance abuse settings are feasible and acceptable to women who smoke and also to the staff who work in these settings. These findings are supported by a recent survey of Canadian addiction programs in which over half of the 223 programs responding to the survey report providing some assistance with quitting smoking (Currie, Nesbitt, Wood, & Lawson, 2003). The emphasis on smoking cessation in these programs and the strategies used, however, varies considerably.

Experiences of implementing a smoking cessation program within a residential substance abuse program for pregnant and postpartum women indicates that traditional smoking cessation programs designed for individuals who are already motivated to quit smoking are ineffective in this setting (Ker et al., 1996). Their efforts to design an "involuntary smoking cessation program" included a carbon monoxide monitoring system, positive reinforcement for reducing or quitting smoking, and education focused on helping women achieve a higher readiness to quit.

Positive responses to the program, even from previously resistant smokers, suggest that the approach has potential application to women at varying levels of readiness to quit. Although specific recommendations for smoking cessation interventions offered in the context of other substance abuse await the results of well-designed studies, it is clear that tailored cessation interventions should be offered to pregnant and postpartum women in substance abuse settings--to those women requesting assistance to stop smoking as well as to those who are unmotivated to quit.

Interventions for Postpartum Smokers

Our review of the literature reveals that there have been relatively few programs or interventions developed to support the maintenance of cessation among postpartum women or girls who quit smoking during pregnancy. Increased interest in helping pregnant women with long-term smoking cessation has stimulated the development of interventions and programs focused on preventing postpartum smoking relapse that include: 1) providing information and advice to women about the benefits of long-term cessation both for their children and themselves, and 2) skill-building to manage high-risk situations and slips (Dunphy, 2000; Johnson et al., 2000/Ratner, Johnson, Bottorff, Dahinten, & Hall, 2000; Van't Hof, Wall, Dowler, & Stark, 2000; Wall and Severson, 1995/Severson, Andrews, Lichtenstein, Wall, & Akers, 1997; Secker-Walker et al., 1995; McBride et al., 1999; DiClemente et al., 2000/Mullen, DiClemente, & Bartholomew, 2000). The interventions have included a variety of self-help materials (in printed or video formats), tailored letters or newsletters, one-to-one brief counselling sessions (either in person or by telephone), and chart reminders. With one exception, these interventions have been individually focused on the women themselves. Project PANDA, however, specifically targets the partners as well as the women with the newsletters and videos during the final weeks of pregnancy and the first six weeks postpartum to help prevent transition back to smoking (DiClemente, Muller, & Windsor, 2000/Mullen, DiClemente, & Bartholomew, 2000).

Some of the postpartum interventions to prevent smoking relapse have been more intensive than others. However, they have not extended beyond the first 3-4 months postpartum. Although some short-term benefits have been observed in cessation or tobacco reduction (e.g., at six months postpartum), in most studies this effect has been observed to decrease over time, suggesting the postpartum interventions may simply slow down or delay relapse (McBride et al., 1999; Ratner et al., 2000; Secker-Walker et al., 1995; Severson et al., 1997). There is some evidence to suggest that the interventions have not been successful with some kinds of pregnant quitters in the postpartum period (e.g., women who have partners who smoke; those who were heavy smokers; those with poorer mental health). The Project PANDA video and print materials tailored to the male perspective are a promising new development in postpartum relapse prevention interventions. Men appeared to use and read the materials and it appeared that the materials may have influenced their smoking to some degree (DiClemente et al., 2000). This is an area that clearly needs further development and evaluation.

There is insufficient evidence to recommend any particular intervention or program components to prevent postpartum smoking relapse. However, important considerations for supporting continued abstinence during the postpartum periods include: 1) the length of time for which support may be needed to maintain long-term abstinence (support beyond the immediate postpartum period appears to be necessary), and 2) addressing other factors that influence women's ability to remain smoke free (e.g., partner smoking, women's mental health). Because adolescents have not been the focus of any postpartum smoking relapse prevention initiatives, it remains unclear how postpartum interventions should be tailored specifically for this group.

As far as we know, there have been no postpartum interventions developed for women and girls who continued to smoke during pregnancy or who resumed smoking prior to delivery. A different set of interventions will be required for this subgroup. Although difficulties may be encountered in promoting smoking cessation among this subgroup of postpartum women and girls, tobacco reduction and assisting women/girls in creating smoke-free homes for their children are important goals. One group of researchers has demonstrated some preliminary but very modest support for a one-to-one motivational intervention for "resistant" smokers during late pregnancy (Stotts, DiClemente, & Mullen, 2002). Their approach may provide a basis for developing innovative interventions for postpartum smokers.

Smoking Cessation Programs for Pregnant Women and Girls

"Program" in this Review constitutes a smoking cessation method primarily identifiable through its materials, rather than a method identifiable through academic literature evaluating its efficacy. As described on pages 29 and 34, programs without accompanying data on smoking outcomes have been considered separately. The components of these unevaluated programs were compared with the components of recommended interventions (see page 25), and those programs with similar content were classified as "showing promise."

In total, nine programs that specifically target pregnant and postpartum women were examined. Four of these programs had evaluation data, and were analyzed according to the same criteria as the smoking cessation interventions described on page 26. All four of the evaluated programs scored zero or lower on our study rating scale and were consequently eliminated from the Review (described in Appendix 8c). The remaining five programs, lacking evaluation data, are presented in Table 4.4.

The programs described in Table 4.4 are generally based on self-help, Prochaska and DiClemente's Transtheoretical Model (e.g., Prochaska et al., 1992), and motivational interviewing techniques. While it is impossible to say for certain which, if any, of these components could potentially affect cessation, based on the available evidence (summarized in Section 4a) self-help programs seem to be a promising avenue of intervention. However, the majority of self-help guides examined in this review were presented and explained to women by health professionals during a prenatal visit, which may have accounted for some of the treatment effect.

Only three programs were identifiably targeted at sub-groups of pregnant and/or postpartum women; two with evaluation data, both eliminated due to insufficient evidence; and one video listed in Table 4.4. As outlined in Section 4e, interventions presented in alternative, more intensive formats may be more appropriate for sub-populations of pregnant women including ethnic minorities and women of low socio-economic standing. Consequently, no unevaluated programs targeted at sub-groups of pregnant smokers can be recommended as "showing promise."

Table 4.3 Studies Included in the Review

Stage of Review	Number of Studies (n)
Data collection	70
Study rating system	58 (12 studies scored ≤ 0)
Effectiveness criteria	20 (38 studies showed no effect)
Strength of evidence criteria	6 (14 studies had insufficient evidence)
Plausibility criteria	6 (0 studies lacked plausibility)
Recommended studies	6

Table 4.4 Unevaluated Programs Targeted at Pregnant/Postpartum Women

Program	Country	Target Population	Provider	Intervention Components
Baby's Coming, Baby's Home*	Canada	Pregnant Smokers ("low-income")	Health professionals, educators and other resource people	Information; tailored information (video); to be used in conjunction with counselling
Great Start*	US	Pregnant Smokers	Self-help	Tailored information (Great Start Self-Help Guide)
Holding Our Own*	Canada	Pregnant Aboriginal Women/Women of colour Smokers	Video (encourages use of peer support group)	Tailored information (video)
New Start*	Canada	Pregnant Smokers	Self-help (available online)	Tailored information (self-help guide)
Start Quit, Stay Quit* Technical Report Available: Edwards et al., 1997	Canada	Pregnant Smokers	Self-help	Tailored information for partners and pregnant smokers; designed to be used in conjunction with counselling adsad

* see Appendix 8e for Contact Information

Over 50 agencies were contacted across Canada in an effort to uncover relevant program materials, yet only nine cessation programs for pregnant women were obtained for review. This stems in part from historically unstable funding of cessation programs and in part from the lack of an updated and regularly maintained registry of cessation resources. Even more scarce are evaluation data for these programs - only four of the nine programs were evaluated and, in each of those cases, the evaluation design rendered any results moot.