Clinical trial NCT02211430: Smoking Cessation for Low-Income Pregnant Women
Official title: Smoking Cessation for Low-Income Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Smoking
Keywords: smoking cessation
pregnancy
postpartum
intervention
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation intervention for low-income, minority women conducted in the prenatal and postpartum phases. Considering the strong link between tobacco use and cancer risk, the development of effective smoking cessation treatments has important health implications for cancer prevention and control initiatives. The aims to be addressed are:

Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e., continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short- and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show reduced rates of tobacco use, versus those in the BP, over time.

Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on change of smoking behaviors.

Detailed description: Rates of Smoking Among Pregnant and Postpartum Women.

Despite the well-established health risks of prenatal and postpartum smoking, a sizable number of pregnant women and new mothers smoke. About 30% of US women who become pregnant smoke. Only 20-40% of these women spontaneously quit upon learning of their pregnancy. Although an additional 3-16% of pregnant smokers may quit later in pregnancy, the majority continue to smoke throughout, with 15-30% relapsing. Research has also indicated that smoking cessation rates are lower among low-income pregnant women (6-14%) versus more affluent populations. Less educated, lower SES, unemployed women who have a higher addiction to nicotine are at greatest risk for smoking throughout their pregnancy, while pregnant women with higher levels of education and income are more likely to quit. These differential smoking rates result in elevated rates of high-risk pregnancies for low SES and less educated women, vs. higher SES and educated women. While some research has demonstrated moderate success with prenatal smoking cessation interventions, relapse remains a prominent concern. Indeed, more than a quarter of women who quit spontaneously relapse by 6-weeks postpartum, with relapse rates reported as high as 60-80% by 6-months postpartum. The highest relapse rates have been found among women with low income and little education.

Smoking Cessation Interventions for Prenatal and Postpartum Women.

To date, the efficacy of available smoking cessation interventions has been disappointing. The current literature on tobacco control indicates that cognitive-affective factors (including perceived risk, self-efficacy, fatalism, decisional balance, and affect) need to be considered when designing smoking cessation protocols. Yet, the behavioral treatments that have been tested for pregnant smokers focus on the use of self-help guides, basic skills training, and education, neglecting the individual's cognitive-affective profile of barriers. This limitation is paralleled by a similar void in the broader smoking cessation literature. When these characteristics are addressed, they have been considered in isolation, without attention to the full spectrum of cognitive-affective barriers to quitting (i.e., the interventions focus on only 1 barrier such as perceived risk or depression). Not surprisingly, among intervention studies with pregnant women, only 3 produced quit rates above 20%.

Thus, research now needs to build upon these guidelines to develop more potent smoking cessation interventions. The design of our intervention is directly responsive to the call for the development of more creative and powerful behavioral interventions to replace the current best available programs. Guided by the Cognitive-Social Health Information Processing (C-SHIP) model and based on our related behavior change protocols for low-income populations, our approach is tailored to the woman's cognitive-affective profile of barriers to initial, and sustained, uptake of smoking cessation.

Determinants of Smoking Cessation Among Pregnant Women.

The exploration of psychological factors as potential mediators of behavior change appears to be particularly promising. The specific cognitive and affective processes proposed by the C-SHIP model as determinants of the uptake of individual health-protective behaviors (e.g., smoking cessation) include: 1) perceived risk; 2) self-efficacy and fatalistic beliefs; 3) expectancies of consequences (i.e., the pros and cons of cessation); and 4) emotional distress. Over the past decade, a sizable literature has accumulated with respect to the psychological correlates of smoking behavior.

Procedures and Interventions

Women who were between 1-25 weeks gestation were asked to participate in a study aimed at learning about smoking cessation techniques for quitting and relapse prevention. Following recruitment and informed consent, participants were randomly assigned to one of two groups, which varied in intensity: 1) the control group, which provided a brief counseling of educational advice and assistance for quitting during each session or 2) a more intensive theoretically-guided smoking cessation intervention group based on the team's Cognitive-Social Health Information Processing Model (C-SHIP ), which assessed and addressed the participant's distinctive pattern of risk perceptions, expectancies and beliefs, and affective reactions. Through prompts and role-play exercises in the context of in-person counseling, potential barriers to cessation can be triggered in a safe, supportive environment. Baseline and follow-up assessments were conducted at 13-25 weeks gestation, 26-38 weeks gestation, 2-6 weeks postpartum and 20-22 weeks postpartum.

Best Practice (BP) control condition consisted of two on-site 10-15 minutes sessions (session 1 and 3), pick up a smoking cessation guide/brochure (session 2), and receive an educational new letter by mail (booster session). CBC intervention included two 45 minutes on-site counseling sessions session 1 and 3), one 15-minutes on-site counseling session (session 2), and one 15-minutes phone session (booster session).

Eligibility criteria: Inclusion Criteria:

* Being pregnant
* Having smoked one puff of a cigarette in the 30 days prior to recruitment (1- 25 weeks post-gestation)
* Being 18 years or older
* Being reachable by a telephone.

Exclusion Criteria:

* An inability to communicate readily in English
* Receiving substance abuse treatment and/or evidence of drug and alcohol abuse

Primary outcomes:
measure: Smoking Cessation Status
timeFrame: prepartum follow-up (26-38 weeks gestation)
measure: Smoking Cessation Status
timeFrame: postpartum follow-up (2-6 weeks postpartum)
measure: Smoking Cessation Status
timeFrame: 3-month post intervention follow up (20-22 weeks postpartum)
Secondary outcomes:
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
timeFrame: prepartum follow-up (26-38 weeks gestation)
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
timeFrame: postpartum follow-up (2-6 weeks postpartum)
measure: Average Number of Cigarettes Smoked Per Day in Past 7 Days
timeFrame: 3-month post intervention follow up (20-22 weeks postpartum)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Suzanne Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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