Smoking Cessation and Relapse Prevention in Women Postpartum
Smoking Cessation and Relapse Prevention in Women Postpartum
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.
5.1.1 Sample The 526,761-inhabitant region of West Pomerania comprises 28 pediatric
 practices. 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. A power analysis on grounds of data from Johnson et
 al. (2000) and using the software nquery (Elashoff, 2000) revealed that a sample size of 259
 women per group will provide a power of 80 % using the five percent one-tailed significance
 level to compare the experimental and the control group with regard to the prevalence of
 sustained smoking abstinence 6 months after intervention by a two groups continuity corrected
 Chi2-test of equal proportions. Assuming an attrition of approximately 25 %, it results in a
 sample size of 330 women per group. According to the statistical regional authorities of the
 mentioned region, 3,527 babies were born alive in the year 1998. Therefore 1,234 mothers
 smoking at the beginning of pregnancy (35 %) per year are expected. Assuming a pediatric
 practice participation rate of 70 % and an 80 % participation rate of women eligible for the
 study, about one year of data gathering will be necessary to reach the estimated total sample
 size of 660 mothers.

 5.1.2 Procedure Procedure of the study This study is a randomized controlled trial following
 a repeated measures factorial design and enabling the comparison of one intervention group
 with a control group. The work plan of the study incorporates 6 months of preparatory work
 including the adaptation of instruments for the assessment of core constructs of the
 Transtheoretical Model and a pre-test, 12 months of screening by receptionists in pediatric
 practice and the recruitment of eligible women for the study by the pediatrician after giving
 written informed consent (figure 1). Random assignment to control and intervention group will
 be done after forwarding the women's addresses to the liaisonal service provided by research
 staff. The intervention phase of the study will be completed 6 months after the last
 recruitment. Follow-ups will be carried out 6, 12, 18 and 24 months after baseline
 assessment. Data analyses and publication will be started in the third year. Analysis of the
 18 and 24 month data will exceed the three year period of support.

 Figure 1: Time schedule postpartum tobacco smoking relapse prevention intervention

 Procedure for participants Figure 2 details the succession of steps for participants. Every
 woman at her first postpartum visit to a pediatric practice (usually 4 to 6 weeks after
 giving birth) will be screened by receptionists concerning her smoking status, considering
 the time at the beginning of the pregnancy, and informed about the study by the pediatrician.
 All participants will receive treatment as usual at the time of preventive examination of
 newborns by the pediatrician. After baseline assessment by phone, the intervention group will
 receive an initial face-to-face counseling at home one week after the pediatric practice
 visit at home. Two brush-up counseling sessions will be provided by phone 3 and 6 months
 later. Follow-up assessment will be conducted by phone.

 Figure 2: Procedure for participants

 5.1.3 Intervention In the intervention group, motivational interviewing will be conducted by
 psychologists qualified by a comprehensive training curriculum offered at the University of
 Greifswald according to Miller & Rollnick (1991). Face-to-face and phone counseling will be
 tailored by data from baseline assessment and are conceived for a duration of up to 45
 minutes. A tailored information and self-help manual will be given at the initial counseling.
 If the allowance of the participant is received, a tape recording of a random selection of
 counseling sessions will be done for intervention control. The control group will receive
 advice as usual from the pediatrician.

 5.1.4 Measures To ensure cross-study comparison, all measures will be operationalized by
 internationally standardized and validated state of the art instruments, if available.

 Pre-intervention measures

 -  pregnancy history

 -  smoking behavior and history, severity of nicotine dependence

 -  environmental smoking

 -  health behavior

 -  child health

 -  Adapted Transtheoretical Model core constructs (Stage allocation, processes of change,
 decisional balance, and temptation/self-efficacy) based on previous work of Ruggiero et
 al. (2000) and Bane et al. (1999).

 Post-intervention measure

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

 -  Adapted Transtheoretical Model core constructs

 Statistical analysis for the main outcome measure will be done by Chi²-test, T-test and
 repeated measure MANOVA. Outcome predictors will be analyzed by logistic regression analysis.

 5.2 Collaboration 5.2.1 Within EARLINT There will be a close cooperation within EARLINT with
 all studies comprising motivational enhancement intervention by personal counseling. Quality
 assurance and training curricula will be matched for all projects.

 5.2.2 External This study will be conducted in cooperation with pediatric offices in West
 Pomerania. Contact has been established with the regional professional organization of
 pediatricians and Prof. Fusch (Department for Pediatrics at the University of Greifswald).
 Further collaboration exists with the only research group with comparable work in Germany
 (Dr. Lang, Prof. Greiser, University of Bremen).

 5.3 Ethical and legal correctness All ethical and legal safeguards have been met. The study
 is currently being refereed by the local ethical committee. The study involves no risk to
 participants. To the contrary, health benefits are expected. Individuals will be informed of
 their right to refuse to participate in any or all aspects of the study and will be given
 opportunities to terminate enrollment. Informed consent forms and an introductory letter will
 assure individuals that their participation is voluntary and that data protection laws have
 been met.
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.