Skip to main content
Tobacco Control logoLink to Tobacco Control
. 2003 Jun;12(2):168–177. doi: 10.1136/tc.12.2.168

A cluster randomised controlled trial of smoking cessation in pregnant women comparing interventions based on the transtheoretical (stages of change) model to standard care

T Lawrence 1, P Aveyard 1, O Evans 1, K Cheng 1
PMCID: PMC1747729  PMID: 12773727

Abstract

Objectives: To evaluate the effectiveness in helping pregnant women stop smoking of two interventions (Pro-Change for a healthy pregnancy) based on the transtheoretical model of behaviour change (TTM) compared to current standard care.

Design: Cluster randomised trial.

Setting: Antenatal clinics in West Midlands, UK general practices.

Participants: 918 pregnant smokers

Interventions: 100 general practices were randomised into the three trial arms. Midwives in these practices delivered three interventions: A (standard care), B (TTM based self help manuals), and C (TTM based self help manuals plus sessions with an interactive computer program giving individualised smoking cessation advice).

Main outcome measures: Biochemically confirmed smoking cessation for 10 weeks previously, and point prevalence abstinence, both measured at 30 weeks of pregnancy and 10 days after delivery.

Results: There were small differences between the TTM arms. Combining the two arms, the odds ratios at 30 weeks were 2.09 (95% confidence interval (CI) 0.90 to 4.85) for 10 week sustained abstinence and 2.92 (95% CI 1.42 to 6.03) for point prevalence abstinence relative to controls. At 10 days after delivery, the odds ratios were 2.81 (95% CI 1.11 to 7.13) and 1.85 (95% CI 1.00 to 3.41) for 10 week and point prevalence abstinence respectively.

Conclusions: While there is a small borderline significant increase in quitting in the combined intervention arms compared with the controls, the effect of the intervention is small. At 30 weeks gestation and at 10 days postnatal, only about 3% of the intervention groups achieved sustained cessation, with numbers needed to treat of 67 (30 weeks of gestation) and 53 (10 weeks postnatal) for one additional woman to achieve sustained confirmed cessation. Given also that the intervention was resource intensive, it is of doubtful benefit.

Full Text

The Full Text of this article is available as a PDF (370.8 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Aveyard P., Cheng K. K., Almond J., Sherratt E., Lancashire R., Lawrence T., Griffin C., Evans O. Cluster randomised controlled trial of expert system based on the transtheoretical ("stages of change") model for smoking prevention and cessation in schools. BMJ. 1999 Oct 9;319(7215):948–953. doi: 10.1136/bmj.319.7215.948. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Aveyard P., Sherratt E., Almond J., Lawrence T., Lancashire R., Griffin C., Cheng K. K. The change-in-stage and updated smoking status results from a cluster-randomized trial of smoking prevention and cessation using the transtheoretical model among British adolescents. Prev Med. 2001 Oct;33(4):313–324. doi: 10.1006/pmed.2001.0889. [DOI] [PubMed] [Google Scholar]
  3. Barić L., MacArthur C. Health norms in pregnancy. Br J Prev Soc Med. 1977 Mar;31(1):30–38. doi: 10.1136/jech.31.1.30. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Cooke M., Mattick R. P., Barclay L. Predictors of brief smoking intervention in a midwifery setting. Addiction. 1996 Nov;91(11):1715–1725. [PubMed] [Google Scholar]
  5. Cooke M., Mattick R. P., Barclay L. Predictors of brief smoking intervention in a midwifery setting. Addiction. 1996 Nov;91(11):1715–1725. [PubMed] [Google Scholar]
  6. Cope G., Nayyar P., Holder R., Gibbons J., Bunce R. A simple near-patient test for nicotine and its metabolites in urine to assess smoking habit. Clin Chim Acta. 1996 Dec 30;256(2):135–149. doi: 10.1016/s0009-8981(96)06417-0. [DOI] [PubMed] [Google Scholar]
  7. Ershoff D. H., Mullen P. D., Quinn V. P. A randomized trial of a serialized self-help smoking cessation program for pregnant women in an HMO. Am J Public Health. 1989 Feb;79(2):182–187. doi: 10.2105/ajph.79.2.182. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Ershoff D. H., Quinn V. P., Boyd N. R., Stern J., Gregory M., Wirtschafter D. The Kaiser Permanente prenatal smoking-cessation trial: when more isn't better, what is enough? Am J Prev Med. 1999 Oct;17(3):161–168. doi: 10.1016/s0749-3797(99)00071-9. [DOI] [PubMed] [Google Scholar]
  9. Hajek P., West R., Lee A., Foulds J., Owen L., Eiser J. R., Main N. Randomized controlled trial of a midwife-delivered brief smoking cessation intervention in pregnancy. Addiction. 2001 Mar;96(3):485–494. doi: 10.1046/j.1360-0443.2001.96348511.x. [DOI] [PubMed] [Google Scholar]
  10. Hajek P., West R., Lee A., Foulds J., Owen L., Eiser J. R., Main N. Randomized controlled trial of a midwife-delivered brief smoking cessation intervention in pregnancy. Addiction. 2001 Mar;96(3):485–494. doi: 10.1046/j.1360-0443.2001.96348511.x. [DOI] [PubMed] [Google Scholar]
  11. Jarvis M. J., Tunstall-Pedoe H., Feyerabend C., Vesey C., Saloojee Y. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987 Nov;77(11):1435–1438. doi: 10.2105/ajph.77.11.1435. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Kendrick J. S., Zahniser S. C., Miller N., Salas N., Stine J., Gargiullo P. M., Floyd R. L., Spierto F. W., Sexton M., Metzger R. W. Integrating smoking cessation into routine public prenatal care: the Smoking Cessation in Pregnancy project. Am J Public Health. 1995 Feb;85(2):217–222. doi: 10.2105/ajph.85.2.217. [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. May S., West R. Do social support interventions ("buddy systems") aid smoking cessation? A review. Tob Control. 2000 Dec;9(4):415–422. doi: 10.1136/tc.9.4.415. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Melvin C. L., Dolan-Mullen P., Windsor R. A., Whiteside H. P., Jr, Goldenberg R. L. Recommended cessation counselling for pregnant women who smoke: a review of the evidence. Tob Control. 2000;9 (Suppl 3):III80–III84. doi: 10.1136/tc.9.suppl_3.iii80. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Orleans C. T., Barker D. C., Kaufman N. J., Marx J. F. Helping pregnant smokers quit: meeting the challenge in the next decade. Tob Control. 2000;9 (Suppl 3):III6–II11. doi: 10.1136/tc.9.suppl_3.iii6. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Owen L. Smoking and pregnancy. The role of midwives. Pract Midwife. 1999 Apr;2(4):14–15. [PubMed] [Google Scholar]
  17. Prochaska J. O., DiClemente C. C., Velicer W. F., Rossi J. S. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol. 1993 Sep;12(5):399–405. doi: 10.1037//0278-6133.12.5.399. [DOI] [PubMed] [Google Scholar]
  18. Prochaska J. O., DiClemente C. C., Velicer W. F., Rossi J. S. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol. 1993 Sep;12(5):399–405. doi: 10.1037//0278-6133.12.5.399. [DOI] [PubMed] [Google Scholar]
  19. Prochaska J. O., DiClemente C. C., Velicer W. F., Rossi J. S. Standardized, individualized, interactive, and personalized self-help programs for smoking cessation. Health Psychol. 1993 Sep;12(5):399–405. doi: 10.1037//0278-6133.12.5.399. [DOI] [PubMed] [Google Scholar]
  20. Prochaska J. O., Velicer W. F., Fava J. L., Rossi J. S., Tsoh J. Y. Evaluating a population-based recruitment approach and a stage-based expert system intervention for smoking cessation. Addict Behav. 2001 Jul-Aug;26(4):583–602. doi: 10.1016/s0306-4603(00)00151-9. [DOI] [PubMed] [Google Scholar]
  21. Prochaska J. O., Velicer W. F., Fava J. L., Ruggiero L., Laforge R. G., Rossi J. S., Johnson S. S., Lee P. A. Counselor and stimulus control enhancements of a stage-matched expert system intervention for smokers in a managed care setting. Prev Med. 2001 Jan;32(1):23–32. doi: 10.1006/pmed.2000.0767. [DOI] [PubMed] [Google Scholar]
  22. Roland M., Torgerson D. J. What are pragmatic trials? BMJ. 1998 Jan 24;316(7127):285–285. doi: 10.1136/bmj.316.7127.285. [DOI] [PMC free article] [PubMed] [Google Scholar]
  23. Tappin D. M., Lumsden M. A., McIntyre D., Mckay C., Gilmour W. H., Webber R., Cowan S., Crawford F., Currie F. A pilot study to establish a randomized trial methodology to test the efficacy of a behavioural intervention. Health Educ Res. 2000 Aug;15(4):491–502. doi: 10.1093/her/15.4.491. [DOI] [PubMed] [Google Scholar]
  24. Velicer W. F., Prochaska J. O., Bellis J. M., DiClemente C. C., Rossi J. S., Fava J. L., Steiger J. H. An expert system intervention for smoking cessation. Addict Behav. 1993 May-Jun;18(3):269–290. doi: 10.1016/0306-4603(93)90029-9. [DOI] [PubMed] [Google Scholar]
  25. Velicer W. F., Prochaska J. O., Fava J. L., Laforge R. G., Rossi J. S. Interactive versus noninteractive interventions and dose-response relationships for stage-matched smoking cessation programs in a managed care setting. Health Psychol. 1999 Jan;18(1):21–28. doi: 10.1037//0278-6133.18.1.21. [DOI] [PubMed] [Google Scholar]
  26. West R., McNeill A., Raw M. Smoking cessation guidelines for health professionals: an update. Health Education Authority. Thorax. 2000 Dec;55(12):987–999. doi: 10.1136/thorax.55.12.987. [DOI] [PMC free article] [PubMed] [Google Scholar]
  27. Windsor R. A., Lowe J. B., Perkins L. L., Smith-Yoder D., Artz L., Crawford M., Amburgy K., Boyd N. R., Jr Health education for pregnant smokers: its behavioral impact and cost benefit. Am J Public Health. 1993 Feb;83(2):201–206. doi: 10.2105/ajph.83.2.201. [DOI] [PMC free article] [PubMed] [Google Scholar]
  28. Wisborg K., Henriksen T. B., Secher N. J. A prospective intervention study of stopping smoking in pregnancy in a routine antenatal care setting. Br J Obstet Gynaecol. 1998 Nov;105(11):1171–1176. doi: 10.1111/j.1471-0528.1998.tb09970.x. [DOI] [PubMed] [Google Scholar]

Articles from Tobacco Control are provided here courtesy of BMJ Publishing Group

RESOURCES