PregnancyACSNCT02211430
Smoking Cessation for Low-Income Pregnant Women
A study testing Cognitive-Behavioral Counseling (CBC) in people with Pregnancy and Smoking, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Cognitive-Behavioral Counseling (CBC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- An inability to communicate readily in English
- Receiving substance abuse treatment and/or evidence of drug and alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
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.
Read the 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).
- Being tested
- Cognitive-Behavioral Counseling (CBC), Best Practice (BC) Control
- Keywords
- smoking cessation, pregnancy, postpartum, intervention
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Counseling (CBC)Behavioural
Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min.
Best Practice (BC) ControlBehavioural
For ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current "best practice" guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Counseling (CBC) | Experimental | Cognitive-Behavioral Counseling (CBC) consists of two 45-minute on-site intervention sessions (session 1 and 3), one 15 minute on-site session (session 2), and one 15-minutes phone session (booster session). Receives: Behavioral: Cognitive-Behavioral Counseling (CBC) |
| Best Practice (BP) Control | Active comparator | Best Practice (BP) Control Condition consists of two 10-15 min, on-site intervention sessions (session 1 and 3), one brochure pick-up (session 2), and receipt of a newsletter by mail (booster session). Receives: Behavioral: Best Practice (BC) Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation Status
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
Measured: prepartum follow-up (26-38 weeks gestation)
Smoking Cessation Status
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
Measured: postpartum follow-up (2-6 weeks postpartum)
Smoking Cessation Status
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
Measured: 3-month post intervention follow up (20-22 weeks postpartum)
Secondary outcomes (3)
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
Measured: prepartum follow-up (26-38 weeks gestation)
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
Measured: postpartum follow-up (2-6 weeks postpartum)
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Participants will be asked to indicate how many cigarettes they smoked per day on average in the past 7 days at baseline and each follow-up.
Measured: 3-month post intervention follow up (20-22 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2002
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Miller, Ph.D., Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211430
- Sponsor's protocol ID
- 02-832
- Other IDs
- TURSG-02-227-01-PBP
- Acronym
- ACS
- Status last verified
- Aug 2014
- First submitted
- 13 May 2014
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
DiClemente CC, Dolan-Mullen P, Windsor RA. The process of pregnancy smoking cessation: implications for interventions. Tob Control. 2000;9 Suppl 3(Suppl 3):III16-21. doi: 10.1136/tc.9.suppl_3.iii16.
PubMed 10982900Engstrom, P., Clapper, M., Schnoll, R., & Orleans, C.T. (2000). Prevention of tobacco-related cancers. Baltimore, MD: Williams and Wilkins Publishing.
Miller, S.M. (2000). Tobacco-related cancers can be prevented and controlled. Primary Care & Cancer, 20(6), 8-9.
Miller, S.M., & Diefenbach, M. (1998). C-SHIP: A cognitive-social health information processing approach to cancer. In D. Krantz (Ed.), Perspectives in behavioral medicine. New Jersey: Lawrence Erlbaum.
Miller SM, Rodoletz M, Mangan CE, Schroeder CM, Sedlacek TV. Applications of the monitoring process model to coping with severe long-term medical threats. Health Psychol. 1996 May;15(3):216-25. doi: 10.1037//0278-6133.15.3.216.
PubMed 8698036Miller SM, Shoda Y, Hurley K. Applying cognitive-social theory to health-protective behavior: breast self-examination in cancer screening. Psychol Bull. 1996 Jan;119(1):70-94. doi: 10.1037/0033-2909.119.1.70.
PubMed 8559860Miller, S. M., & Schnoll, R.A. (2000). Coping with stress: examples from the cancer context. In J. M. M. Lewis (Ed.), Handbook of Emotions. NY, NY: Plenum Press.
Orleans CT, Boyd NR, Bingler R, Sutton C, Fairclough D, Heller D, McClatchey M, Ward JA, Graves C, Fleisher L, Baum S. A self-help intervention for African American smokers: tailoring cancer information service counseling for a special population. Prev Med. 1998 Sep-Oct;27(5 Pt 2):S61-70. doi: 10.1006/pmed.1998.0400.
PubMed 9808825Zapka JG, Pbert L, Stoddard AM, Ockene JK, Goins KV, Bonollo D. Smoking cessation counseling with pregnant and postpartum women: a survey of community health center providers. Am J Public Health. 2000 Jan;90(1):78-84. doi: 10.2105/ajph.90.1.78.
PubMed 10630141Aakko E, Piasecki TM, Remington P, Fiore MC. Smoking cessation services offered by health insurance plans for Wisconsin state employees. WMJ. 1999 Jan-Feb;98(1):14-8.
PubMed 10050148Adams MM, Brogan DJ, Kendrick JS, Shulman HB, Zahniser SC, Bruce FC. Smoking, pregnancy, and source of prenatal care: results from the Pregnancy Risk Assessment Monitoring System. The Pregnancy Risk Assessment Monitoring System Working Group. Obstet Gynecol. 1992 Nov;80(5):738-44.
PubMed 1407908Botvin GJ, Epstein JA, Botvin EM. Adolescent cigarette smoking: prevalence, causes, and intervention approaches. Adolesc Med. 1998 Jun;9(2):299-313, vi.
PubMed 10961237Dolan-Mullen P, Ramirez G, Groff JY. A meta-analysis of randomized trials of prenatal smoking cessation interventions. Am J Obstet Gynecol. 1994 Nov;171(5):1328-34. doi: 10.1016/0002-9378(94)90156-2.
PubMed 7977542Ershoff DH, Quinn VP, Mullen PD. Relapse prevention among women who stop smoking early in pregnancy: a randomized clinical trial of a self-help intervention. Am J Prev Med. 1995 May-Jun;11(3):178-84.
PubMed 7662397Fingerhut LA, Kleinman JC, Kendrick JS. Smoking before, during, and after pregnancy. Am J Public Health. 1990 May;80(5):541-4. doi: 10.2105/ajph.80.5.541.
PubMed 2327529
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation for Low-Income Pregnant Women
- ClinicalTrials.gov ID
- NCT02211430
- Acronym / sponsor ID
- ACS / 02-832
- Keywords
- smoking cessation, pregnancy, postpartum, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Counseling (CBC) | Experimental | Behavioral: Cognitive-Behavioral Counseling (CBC)Cognitive-Behavioral Counseling (CBC) consists of two 45-minute on-site intervention sessions (session 1 and 3), one 15 minute on-site session (session 2), and one 15-minutes phone session (booster session). |
| Best Practice (BP) Control | Active comparator | Behavioral: Best Practice (BC) ControlBest Practice (BP) Control Condition consists of two 10-15 min, on-site intervention sessions (session 1 and 3), one brochure pick-up (session 2), and receipt of a newsletter by mail (booster session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- An inability to communicate readily in English
- Receiving substance abuse treatment and/or evidence of drug and alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Counseling (CBC)Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min. | Behavioural | Cognitive-Behavioral Counseling (CBC) |
| Best Practice (BC) ControlFor ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current "best practice" guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4). | Behavioural | Best Practice (BP) Control |
Primary outcome
Smoking Cessation Status
Time frame: prepartum follow-up (26-38 weeks gestation)
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
Smoking Cessation Status
Time frame: postpartum follow-up (2-6 weeks postpartum)
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
Smoking Cessation Status
Time frame: 3-month post intervention follow up (20-22 weeks postpartum)
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be considered smokers. In the case of discrepancies between self-report and biochemical verification from saliva samples, the cotinine level will be used as the criterion.
3 secondary outcomes
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Time frame: prepartum follow-up (26-38 weeks gestation)
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Time frame: postpartum follow-up (2-6 weeks postpartum)
Average Number of Cigarettes Smoked Per Day in Past 7 Days
Time frame: 3-month post intervention follow up (20-22 weeks postpartum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Background: PubMed 10982900DiClemente CC, Dolan-Mullen P, Windsor RA. The process of pregnancy smoking cessation: implications for interventions. Tob Control. 2000;9 Suppl 3(Suppl 3):III16-21. doi: 10.1136/tc.9.suppl_3.iii16.
- BackgroundEngstrom, P., Clapper, M., Schnoll, R., & Orleans, C.T. (2000). Prevention of tobacco-related cancers. Baltimore, MD: Williams and Wilkins Publishing.
- BackgroundMiller, S.M. (2000). Tobacco-related cancers can be prevented and controlled. Primary Care & Cancer, 20(6), 8-9.
- BackgroundMiller, S.M., & Diefenbach, M. (1998). C-SHIP: A cognitive-social health information processing approach to cancer. In D. Krantz (Ed.), Perspectives in behavioral medicine. New Jersey: Lawrence Erlbaum.
- Background: PubMed 8698036Miller SM, Rodoletz M, Mangan CE, Schroeder CM, Sedlacek TV. Applications of the monitoring process model to coping with severe long-term medical threats. Health Psychol. 1996 May;15(3):216-25. doi: 10.1037//0278-6133.15.3.216.
- Background: PubMed 8559860Miller SM, Shoda Y, Hurley K. Applying cognitive-social theory to health-protective behavior: breast self-examination in cancer screening. Psychol Bull. 1996 Jan;119(1):70-94. doi: 10.1037/0033-2909.119.1.70.
- BackgroundMiller, S. M., & Schnoll, R.A. (2000). Coping with stress: examples from the cancer context. In J. M. M. Lewis (Ed.), Handbook of Emotions. NY, NY: Plenum Press.
- Background: PubMed 9808825Orleans CT, Boyd NR, Bingler R, Sutton C, Fairclough D, Heller D, McClatchey M, Ward JA, Graves C, Fleisher L, Baum S. A self-help intervention for African American smokers: tailoring cancer information service counseling for a special population. Prev Med. 1998 Sep-Oct;27(5 Pt 2):S61-70. doi: 10.1006/pmed.1998.0400.
- Background: PubMed 10630141Zapka JG, Pbert L, Stoddard AM, Ockene JK, Goins KV, Bonollo D. Smoking cessation counseling with pregnant and postpartum women: a survey of community health center providers. Am J Public Health. 2000 Jan;90(1):78-84. doi: 10.2105/ajph.90.1.78.
- Background: PubMed 10050148Aakko E, Piasecki TM, Remington P, Fiore MC. Smoking cessation services offered by health insurance plans for Wisconsin state employees. WMJ. 1999 Jan-Feb;98(1):14-8.
- Background: PubMed 1407908Adams MM, Brogan DJ, Kendrick JS, Shulman HB, Zahniser SC, Bruce FC. Smoking, pregnancy, and source of prenatal care: results from the Pregnancy Risk Assessment Monitoring System. The Pregnancy Risk Assessment Monitoring System Working Group. Obstet Gynecol. 1992 Nov;80(5):738-44.
- Background: PubMed 10961237Botvin GJ, Epstein JA, Botvin EM. Adolescent cigarette smoking: prevalence, causes, and intervention approaches. Adolesc Med. 1998 Jun;9(2):299-313, vi.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Miller, Ph.D. principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Counseling (CBC) in people with Pregnancy and Smoking, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation Status (time frame: prepartum follow-up (26-38 weeks gestation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211430, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.