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Smoking Cessation and Relapse Prevention in Women Postpartum (EARLINT-EP3)

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ClinicalTrials.gov Identifier: NCT00475046
Recruitment Status : Completed
First Posted : May 17, 2007
Last Update Posted : May 21, 2007
German Federal Ministry of Education and Research
Information provided by:
University Medicine Greifswald

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Motivational Interviewing Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2790 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smoking Cessation and Relapse Prevention in Women Postpartum
Study Start Date : October 2001
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Adapted Transtheoretical Model core constructs [ Time Frame: 6, 12, 18 and 24 monthy after baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475046

Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
Principal Investigator: Ulfert Hapke, PhD Institut für Epidemiologie und Sozialmedizin, University of Greifswald

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

ClinicalTrials.gov Identifier: NCT00475046     History of Changes
Other Study ID Numbers: 01EB0120-TP3
First Posted: May 17, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by University Medicine Greifswald:
post partum
relapse prevention
motivational interviewing
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

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes