NCT02211430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

4.4 years

First QC Date

May 13, 2014

Last Update Submit

August 6, 2014

Conditions

PregnancySmoking

Keywords

smoking cessationpregnancypostpartumintervention

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (3)

  • Average Number of Cigarettes Smoked Per Day in Past 7 Days

    prepartum follow-up (26-38 weeks gestation)

  • Average Number of Cigarettes Smoked Per Day in Past 7 Days

    postpartum follow-up (2-6 weeks postpartum)

  • Average Number of Cigarettes Smoked Per Day in Past 7 Days

    3-month post intervention follow up (20-22 weeks postpartum)

Study Arms (2)

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).

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).

Behavioral: Best Practice (BC) Control

Interventions

Cognitive-Behavioral Counseling (CBC)BEHAVIORAL

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.

Cognitive-Behavioral Counseling (CBC)
Best Practice (BC) ControlBEHAVIORAL

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).

Best Practice (BP) Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (33)

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    PMID: 10982900BACKGROUND

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    BACKGROUND

  • Miller, S.M. (2000). Tobacco-related cancers can be prevented and controlled. Primary Care & Cancer, 20(6), 8-9.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 8698036BACKGROUND

  • 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. doi: 10.1037/0033-2909.119.1.70.

    PMID: 8559860BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 9808825BACKGROUND

  • 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. doi: 10.2105/ajph.90.1.78.

    PMID: 10630141BACKGROUND

  • 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.

    PMID: 10050148BACKGROUND

  • 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.

    PMID: 1407908BACKGROUND

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

    PMID: 10961237BACKGROUND

  • Dolan-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.

    PMID: 7977542BACKGROUND

  • 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.

    PMID: 7662397BACKGROUND

  • Fingerhut 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.

    PMID: 2327529BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1093/her/12.2.247.

    PMID: 10168576BACKGROUND

  • 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. doi: 10.1016/0029-7844(95)00492-0.

    PMID: 8602320BACKGROUND

  • 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. doi: 10.1016/0306-4603(94)90040-x.

    PMID: 8036963BACKGROUND

  • 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. doi: 10.2105/ajph.85.2.217.

    PMID: 7856781BACKGROUND

  • Kowalski SD. Self-esteem and self-efficacy as predictors of success in smoking cessation. J Holist Nurs. 1997 Jun;15(2):128-42. doi: 10.1177/089801019701500205.

    PMID: 9165803BACKGROUND

  • 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. doi: 10.2105/ajph.87.10.1670.

    PMID: 9357351BACKGROUND

  • 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.

    PMID: 7599672BACKGROUND

  • Matheny KB, Weatherman KE. Predictors of smoking cessation and maintenance. J Clin Psychol. 1998 Feb;54(2):223-35. doi: 10.1002/(sici)1097-4679(199802)54:23.0.co;2-l.

    PMID: 9467767BACKGROUND

  • 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. doi: 10.2105/ajph.80.1.76.

    PMID: 2293809BACKGROUND

  • 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. doi: 10.2105/ajph.89.5.706.

    PMID: 10224982BACKGROUND

  • 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. doi: 10.4278/0890-1171-11.5.323.

    PMID: 10167366BACKGROUND

  • 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. doi: 10.1111/j.1552-6909.1992.tb01755.x.

    PMID: 1403224BACKGROUND

  • 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. doi: 10.1016/0002-9378(94)90159-7.

    PMID: 7977545BACKGROUND

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

    BACKGROUND

  • Valbo A, Nylander G. Smoking cessation in pregnancy. Intervention among heavy smokers. Acta Obstet Gynecol Scand. 1994 Mar;73(3):215-9. doi: 10.3109/00016349409023442.

    PMID: 8122501BACKGROUND

  • 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. doi: 10.2105/ajph.87.7.1201.

    PMID: 9240113BACKGROUND

  • 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. doi: 10.2105/ajph.83.2.201.

    PMID: 8427323BACKGROUND

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Suzanne Miller, Ph.D.

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2014

First Posted

August 7, 2014

Study Start

October 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

US(1)