Smoking Cessation and Relapse Prevention in Women Postpartum

NCT00475046 | Completed Phase 1

• 1 other identifier: 01EB0120-TP3
• Study Type: interventional
• Target: 2,790
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Pregnancy was found to be a significant triggering factor for smoking cessation and the reduction of nicotine consumption, but 50 - 70 % of mothers who stopped smoking during pregnancy resume tobacco smoking after delivery. One main reason for the high relapse rates is that many women are solely motivated to quit smoking for the baby's sake. After birth, the external reason for having quit has vanished and no other internal or external motives exist for many women to maintain being smoke-free. Therefore, under consideration of the Transtheoretical Model approach, relapse prevention and smoking cessation interventions have to focus on two aspects: (1) on a specific reformulation of the stages of change for women who show a temporarily and externally motivated change in smoking behavior during pregnancy, (2) on intervention strategies taking advantage of the behavioral change already done and evoking the cognitive and behavioral processes necessary for maintenance. In Germany pediatricians are in a unique position to address this issue because nearly every mother attends a pediatric practice for preventive examination of the newborn. Objectives: To adapt and implement motivational enhancement interventions in pediatric practices. The aim is to examine the effectiveness of a modified stage-matched motivational enhancement intervention added to the common pediatricians´ advice. A second aim is the reformulation and reassessment of the stages of change for women who have recently given birth. Methods: The study design is a randomized controlled trial. Mothers smoking at the beginning of the pregnancy and attending pediatric practices in West Pomerania will be assigned to an intervention group (n = 330) and referred to a liaisonal service providing a face-to-face motivational enhancement intervention followed by telephone brush-up sessions. A control group (n = 330) receives treatment from the pediatrician as usual at the preventive examination. The core outcome measures comprise abstinence, and progress in the stages of change 6, 12, 18 and 24 months after baseline. Expected impact: Data will evaluate the usefulness of intervening in pediatric offices and will provide information about a tailored intervention program. The processes of change favorable for intervention in this population will be identified. This is of great relevance with regard to the prevention of health damage for mother and child. Furthermore, results will serve as a basis for guidelines for pediatricians to deal with women smoking postpartum. Relationship to the objective of the collaboration: As in the other studies, this study provides empirical data of a new proactive approach to reach underserved populations in the addiction field. This project will add knowledge on how to intervene (motivational enhancement vs. usual advice), on setting-specific advantages of pediatric offices and on the impact of the chosen intervention strategy.

Conditions

Smoking Cessation

Keywords

smoking; post partum; relapse prevention; motivational interviewing; TTM; implement motivational enhancement interventions in pediatric practices; examine the effectiveness of the intervention; develop measurements appropriate to tailor interventions; analyze further unfavorable and favorable factors outlined by previous research

Outcome Measures

Primary Outcomes (1)

• Current and sustained smoking abstinence prevalence, amount of cigarettes smoked per day

  6, 12, 18 and 24 monthy after baseline

Secondary Outcomes (1)

• Adapted Transtheoretical Model core constructs

  6, 12, 18 and 24 monthy after baseline

Interventions

Motivational Interviewing BEHAVIORAL

Eligibility Criteria

• Age: 1 Year+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Every mother presenting her newborn for the first time in the pediatric practices will be screened. Of these, all women smoking at the date the female received verification of her pregnancy are eligible for the study.

Sponsors & Collaborators

• University Medicine Greifswald: lead
• German Federal Ministry of Education and Research: collaborator

Related Publications (12)

• Hannover W, Thyrian JR, Roske K, Kelbsch J, John U, Hapke U. [Interventions to prevent health risks due to tobacco smoke in pregnant women, postpartum women and their infants]. Gesundheitswesen. 2004 Oct;66(10):688-96. doi: 10.1055/s-2004-813602. German.

  PMID: 15499514 BACKGROUND

• Hannover W, Thyrian JR, John U. Short report: Paediatricians' attitude towards counselling parents postpartum about their smoking behaviour. Eur J Public Health. 2004 Jun;14(2):199-200. doi: 10.1093/eurpub/14.2.199.

  PMID: 15230510 BACKGROUND

• Roske K, Hannover W, Kelbsch J, Thyrian JR, John U, Hapke U. [The readiness of women, after they have given birth to children, to participate in individualized counselling for smoking cessation ]. Gesundheitswesen. 2004 Oct;66(10):697-702. doi: 10.1055/s-2004-813621. German.

  PMID: 15499515 BACKGROUND

• Thyrian JR, Hanke M, Hannover W, Grempler J, Roske K, Fusch C, John U. [Exposure to tobacco smoke (passive smoking) in the home and inpatient treatment of children under the age of 5 years in Germany]. Dtsch Med Wochenschr. 2005 May 13;130(19):1189-94. doi: 10.1055/s-2005-868699. German.

  PMID: 15875260 BACKGROUND

• Roske K, Hannover W, Grempler J, Thyrian JR, Rumpf HJ, John U, Hapke U. Post-partum intention to resume smoking. Health Educ Res. 2006 Jun;21(3):386-92. doi: 10.1093/her/cyh069. Epub 2005 Nov 17.

  PMID: 16293673 BACKGROUND

• Thyrian JR, Hannover W, Grempler J, Roske K, John U, Hapke U. An intervention to support postpartum women to quit smoking or remain smoke-free. J Midwifery Womens Health. 2006 Jan-Feb;51(1):45-50. doi: 10.1016/j.jmwh.2005.07.002.

  PMID: 16399610 BACKGROUND

• Thyrian JR, Hannover W, Roske K, Rumpf HJ, John U, Hapke U. Postpartum return to smoking: identifying different groups to tailor interventions. Addict Behav. 2006 Oct;31(10):1785-96. doi: 10.1016/j.addbeh.2005.12.016. Epub 2006 Jan 23.

  PMID: 16431031 BACKGROUND

• Thyrian JR, Hannover W, Roske K, Scherbarth S, Hapke U, John U. Midwives' attitudes to counselling women about their smoking behaviour during pregnancy and postpartum. Midwifery. 2006 Mar;22(1):32-9. doi: 10.1016/j.midw.2005.04.003.

  PMID: 16488809 BACKGROUND

• Roske K, Hannover W, Thyrian JR, Grempler J, Rumpf HJ, John U, Hapke U. [Why woman postpartum resume smoking]. Gesundheitswesen. 2006 Mar;68(3):171-5. doi: 10.1055/s-2006-926639. German.

  PMID: 16575697 BACKGROUND

• John U, Meyer C, Ulbricht S, Schumann A, Freyer-Adam J, Hapke U, Rumpf HJ, Bischof G, Grothues J, Thyrian JR. [Improvement of medical care by supporting the intention to change health risk behavior]. Med Klin (Munich). 2007 Jan 15;102(1):33-6. doi: 10.1007/s00063-007-1006-7. German.

  PMID: 17221350 BACKGROUND

• Thyrian JR, Freyer-Adam J, Hannover W, Roske K, Mentzel F, Kufeld C, Bischof G, Rumpf HJ, John U, Hapke U. Adherence to the principles of Motivational Interviewing, clients' characteristics and behavior outcome in a smoking cessation and relapse prevention trial in women postpartum. Addict Behav. 2007 Oct;32(10):2297-303. doi: 10.1016/j.addbeh.2007.01.024. Epub 2007 Jan 23.

  PMID: 17307300 BACKGROUND

• Thyrian JR, Hannover W, Roske K, John U, Hapke U. Smoking before, during and after pregnancy: Longitudinal data from a population-based sample. Geburtshilfe Und Frauenheilkunde, 65(7), 687-689

  BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ulfert Hapke, PhD

  Institut für Epidemiologie und Sozialmedizin, University of Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: October 1, 2001
• Study Completion: May 1, 2005
• Last Updated: May 21, 2007

Record last verified: 2007-05