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Smoking Cessation and Relapse Prevention in Women Postpartum (EARLINT-EP3)
This study has been completed.
Sponsors and Collaborators: Ernst Moritz Arndt University of Greifswald
German Federal Ministry of Education and Research
Information provided by: Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier: NCT00475046
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Behavioral: Motivational Interviewing
Phase I

MedlinePlus related topics: Quitting Smoking Smoking Smoking and Youth
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Smoking Cessation and Relapse Prevention in Women Postpartum

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:
  • Current and sustained smoking abstinence prevalence, amount of cigarettes smoked per day [ Time Frame: 6, 12, 18 and 24 monthy after baseline ]

Secondary Outcome Measures:
  • Adapted Transtheoretical Model core constructs [ Time Frame: 6, 12, 18 and 24 monthy after baseline ]

Enrollment: 2790
Study Start Date: October 2001
Study Completion Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475046

Sponsors and Collaborators
Ernst Moritz Arndt University of Greifswald
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Ulfert Hapke, PhD Institut für Epidemiologie und Sozialmedizin, University of Greifswald
  More Information

Publications:
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. Review. German.
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.
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. German.
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. German.
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. Epub 2005 Nov 17.
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.
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. Epub 2006 Jan 23.
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.
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. German.
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. German.
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 Jan 23; [Epub ahead of print]

Study ID Numbers: 01EB0120-TP3
Study First Received: May 16, 2007
Last Updated: May 18, 2007
ClinicalTrials.gov Identifier: NCT00475046  
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Ernst Moritz Arndt University of Greifswald:
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

Study placed in the following topic categories:
Smoking
Recurrence

Additional relevant MeSH terms:
Habits
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009