Smoking Cessation for Low-Income Pregnant Women

Pregnancy Clinical Trial

— ACS  

Official title:

Smoking Cessation for Low-Income Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211430
• Other study ID #: 02-832
• Secondary ID: TURSG-02-227-01-
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: August 6, 2014
• Start date: October 2002
• Est. completion date: March 2007

Study information

• Verified date: August 2014
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Smoking

Intervention

Behavioral:
• 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.
• Best Practice (BC) Control
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).

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (33)

Aakko 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. — View Citation

Adams 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. — View Citation

Botvin GJ, Epstein JA, Botvin EM. Adolescent cigarette smoking: prevalence, causes, and intervention approaches. Adolesc Med. 1998 Jun;9(2):299-313, vi. Review. — View Citation

DiClemente CC, Dolan-Mullen P, Windsor RA. The process of pregnancy smoking cessation: implications for interventions. Tob Control. 2000;9 Suppl 3:III16-21. — View Citation

Dolan-Mullen P, Ramírez G, Groff JY. A meta-analysis of randomized trials of prenatal smoking cessation interventions. Am J Obstet Gynecol. 1994 Nov;171(5):1328-34. — View Citation

Engstrom, P., Clapper, M., Schnoll, R., & Orleans, C.T. (2000). Prevention of tobacco-related cancers. Baltimore, MD: Williams and Wilkins Publishing.

Ershoff 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. — View Citation

Fingerhut LA, Kleinman JC, Kendrick JS. Smoking before, during, and after pregnancy. Am J Public Health. 1990 May;80(5):541-4. — View Citation

Fiore, M., Bailey, W., Cohen, S., Dorfman, S., Goldstein, M., Gritz, E., Heyman, R., Jaen, C., Kottke, T., Lando, H., Mecklenburg, R., Dolan-Mullen, P., Nett, L., Robinson, L., Stitzer, M., Tommasello, A., Villejo, L., & Wewers, M. (2000). Treating tobacco use and dependance. Clinical Practic Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.

Gielen AC, Windsor R, Faden RR, O'Campo P, Repke J, Davis M. Evaluation of a smoking cessation intervention for pregnant women in an urban prenatal clinic. Health Educ Res. 1997 Jun;12(2):247-54. — View Citation

Hartmann KE, Thorp JM Jr, Pahel-Short L, Koch MA. A randomized controlled trial of smoking cessation intervention in pregnancy in an academic clinic. Obstet Gynecol. 1996 Apr;87(4):621-6. — View Citation

Hill HA, Schoenbach VJ, Kleinbaum DG, Strecher VJ, Orleans CT, Gebski VJ, Kaplan BH. A longitudinal analysis of predictors of quitting smoking among participants in a self-help intervention trial. Addict Behav. 1994 Mar-Apr;19(2):159-73. — View Citation

Kendrick JS, Zahniser SC, Miller N, Salas N, Stine J, Gargiullo PM, Floyd RL, Spierto FW, Sexton M, Metzger RW, et al. Integrating smoking cessation into routine public prenatal care: the Smoking Cessation in Pregnancy project. Am J Public Health. 1995 Feb;85(2):217-22. — View Citation

Kowalski SD. Self-esteem and self-efficacy as predictors of success in smoking cessation. J Holist Nurs. 1997 Jun;15(2):128-42. — View Citation

Lando HA, Rolnick S, Klevan D, Roski J, Cherney L, Lauger G. Telephone support as an adjunct to transdermal nicotine in smoking cessation. Am J Public Health. 1997 Oct;87(10):1670-4. — View Citation

Lillington L, Royce J, Novak D, Ruvalcaba M, Chlebowski R. Evaluation of a smoking cessation program for pregnant minority women. Cancer Pract. 1995 May-Jun;3(3):157-63. — View Citation

Matheny KB, Weatherman KE. Predictors of smoking cessation and maintenance. J Clin Psychol. 1998 Feb;54(2):223-35. — View Citation

Mayer JP, Hawkins B, Todd R. A randomized evaluation of smoking cessation interventions for pregnant women at a WIC clinic. Am J Public Health. 1990 Jan;80(1):76-8. — View Citation

McBride CM, Curry SJ, Lando HA, Pirie PL, Grothaus LC, Nelson JC. Prevention of relapse in women who quit smoking during pregnancy. Am J Public Health. 1999 May;89(5):706-11. — View Citation

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. — View Citation

Miller 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. Review. — View Citation

Miller, 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.

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.

Mullen PD, Richardson MA, Quinn VP, Ershoff DH. Postpartum return to smoking: who is at risk and when. Am J Health Promot. 1997 May-Jun;11(5):323-30. — View Citation

O'Connor AM, Davies BL, Dulberg CS, Buhler PL, Nadon C, McBride BH, Benzie RJ. Effectiveness of a pregnancy smoking cessation program. J Obstet Gynecol Neonatal Nurs. 1992 Sep-Oct;21(5):385-92. — View Citation

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. — View Citation

Secker-Walker RH, Solomon LJ, Flynn BS, Skelly JM, Lepage SS, Goodwin GD, Mead PB. Individualized smoking cessation counseling during prenatal and early postnatal care. Am J Obstet Gynecol. 1994 Nov;171(5):1347-55. — View Citation

Valbø A, Nylander G. Smoking cessation in pregnancy. Intervention among heavy smokers. Acta Obstet Gynecol Scand. 1994 Mar;73(3):215-9. — View Citation

Valbo, A., & Schioldborg, P. (1994). Smoking cessation in pregnancy: the effects of self-help manuals. Journal of Maternal Fetal Investigation, 4, 167-170.

Walsh RA, Redman S, Brinsmead MW, Byrne JM, Melmeth A. A smoking cessation program at a public antenatal clinic. Am J Public Health. 1997 Jul;87(7):1201-4. — View Citation

Windsor RA, Lowe JB, Perkins LL, Smith-Yoder D, Artz L, Crawford M, Amburgy K, Boyd NR Jr. Health education for pregnant smokers: its behavioral impact and cost benefit. Am J Public Health. 1993 Feb;83(2):201-6. — View Citation

Zapka 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. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	prepartum follow-up (26-38 weeks gestation)	No
Primary	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.	postpartum follow-up (2-6 weeks postpartum)	No
Primary	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.	3-month post intervention follow up (20-22 weeks postpartum)	No
Secondary	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.	prepartum follow-up (26-38 weeks gestation)	No
Secondary	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.	postpartum follow-up (2-6 weeks postpartum)	No
Secondary	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.	3-month post intervention follow up (20-22 weeks postpartum)	No