Cigarette Smoking Clinical Trial
Official title:
Postnatal Smoking Relapse, Its Associated Risk Factors, and a Proactive Sustainable Preventive Intervention
This study will assess the extent of postpartum smoking relapse among Romanian women, the associated risk factors, and will develop, implement, and pilot-test a randomized trial smoking relapse intervention incorporating innovative research concepts in a social and cultural acceptable manner. The primary hypothesis is that the intervention will increase mothers' smoking abstinence rates.
Overview.
This four-year longitudinal project will enroll a total of 425 women who spontaneously quit
smoking during pregnancy. The recruitment will take place during the delivery hospital stay
in two of the largest obstetric-gynecology hospitals in Cluj-Napoca, Romania. The
investigators will design, pre-test (Objective 1), apply, and evaluate a postpartum smoking
relapse preventive randomized intervention among the first 250 recruited women and their
husbands (Objective 2): 125 couples in the intervention group and 125 couples in the control
group, comparing the women's relapse rates at 6 months postpartum. The project will continue
to enroll and follow-up 175 additional women for a total of 300 not subjected to the
intervention (125+175) to assess the extent of postpartum smoking relapse and associated
risk factors in a prospective cohort study (Objective 3).
The work plan.
The first 6 months of the project consisted of a preparatory phase. Objective 1 was
completed in the first 9 months of the project, and milestones included focus groups,
interviews with women, their husbands, and medical staff, the design of the intervention and
pre-testing its acceptability. Objective 2 is completed between months 10-24 of the project.
Milestones include: recruiting 250 couples (months 10-30), applying the intervention (months
10-33), the follow-up assessment (months 16-36), and preliminary analyses (months 13-36).
Objective 3 is completed between months 19-45 of the project. Milestones include: recruiting
175 additional women (months 19-39), the follow-up assessment (months 25-45), and
preliminary analyses (months 22-45). The last 12 months (months 37-48) of the project will
be used to conclude the project, including finalizing the database and analyses, preparing a
final report, and preparing articles for publication.
Objective 1: Design, pre-test, and refine an innovative intervention for preventing smoking
relapse after pregnancy to maximize feasibility and potential impact.
This objective represented the qualitative developmental phase of the postpartum relapse
intervention in order to tailor the intervention to the needs of the target population. The
focus-groups and interviews aimed to qualitatively explore the issues related to the women's
motivation and self-efficacy, the two key components of the planned intervention. To develop
the postpartum smoking relapse intervention strategy the Motivation and Problem Solving
(MAPS) strategy of Reitzel and colleagues was followed, the newest approach in the relapse
prevention field, incorporating both motivational and self-efficacy components into the
intervention, adapted to local attitudes and preferences. MAPS was successful in preventing
relapse. The intervention is based on Motivational Interviewing and the seminal relapse
prevention model, probably the most prominent theory of smoking cessation and relapse.
Self-efficacy is viewed as the principal causal determinant of successful abstinence, among
other individual and contextual factors, is hypothesized to increase. The model also
specifies that the individual needs to be sufficiently motivated to avoid relapse. Briefly,
the phone counseling sessions consist of information about the benefits of abstinence to
increase motivation, and helping women identify and manage high-risk relapse situations,
therefore enhancing their self-efficacy. The aim is to deliver consistent repeated advice by
a trained professional over the phone in the postpartum period. Following the newest
approaches in the field, the smoking husbands/partners are also targeted with brief
motivational advice using the birth as a teachable moment to quit. Two psychologists were
trained to deliver the phone motivational advice. Self help materials were also created and
are distributed to all 250 women participating in the trial. A randomization algorithm was
set up to assign patients into the intervention or control groups.
Objective 2: Implement and evaluate an intervention to prevent maternal smoking relapse
after pregnancy in a randomized controlled trial setting.
Participants. The aim is to recruit 250 pre-randomized (125 intervention vs. 125 control
group) mothers at birth who quit smoking in the 2 months before pregnancy or no later than
the end of 1st pregnancy trimester and remained abstinent until delivery, biochemically
confirmed through expired carbon monoxide. The mothers are approached during the delivery
hospital stay in two of the largest obstetrics-gynecology clinics in Cluj-Napoca, Romania.
Enrollment criteria include willingness and ability to participate in the study, age 18 or
older, married or living with a stable partner, with a mobile phone, and willing to provide
mobile phone contact for their husband or partner. Their husband or life partner is also
approached and invited into the study at recruitment, if present, or by phone in the first
weeks after birth.
Procedures. At enrollment, all 250 participants are given self-help materials and 5-10 min
of brief advice offered by the trained research personnel consisting of encouragement to
remain quit, and a review of the smoking risks and the benefits of abstinence. The mothers
in the intervention group additionally receive three telephone-based counseling sessions
delivered by trained professionals over the phone at 1 week, 1 month, and 3 months after
birth. All smoking husbands or partners of the mothers in the intervention group are
contacted in the first weeks after birth and are offered one phone motivational session to
quit and support their wife's abstinence. To incentivize the couples to remain in the study
and to appreciate their time and effort, gift certificates are mailed for baby-related
merchandise around the 1-month and 6-month follow-up contacts.
Outcomes. The project follows-up with the couples at 6 months postpartum. Postpartum
maternal abstinence is the main outcome, defined as maintaining smoke-free status
continuously until the 6-month follow-up. The postpartum maternal abstinence is
biochemically verified through expired carbon monoxide (CO) at 6-months postpartum (CO) <10
ppm. Secondary outcomes of interest are the maternal number of cigarettes smoked,
self-efficacy, and motivation. The self-reported smoke status of the husband/partner is
another outcome of interest.
Maternal characteristics. An extended prenatal questionnaire is used at recruitment and at
the 6-month follow-up. Based on the prior literature on the predictors of postpartum
relapse, the questionnaire includes demographics (such as age, education, and ethnicity),
health history (prior pregnancies history, contraception use and feelings about the
pregnancy), mental health (depressive symptoms, stress, anxiety), nicotine dependence before
quitting, an extensive section on smoking knowledge and attitudes, other substance use,
breast feeding, and having a life partner who smokes (as reported by the new mother).
Analytical plan. The required sample (100 intervention vs. 100 control at final follow-up)
was calculated assuming abstinence rates of 0.3-0.4 (70% or 60% relapse) in the control
group compared to anticipated 0.5-0.6 in intervention group, in order to attain 80%
statistical power to detect the difference in two-tailed comparisons, alpha 0.05. Beginning
with 125 couples in the intervention vs. 125 in the control group at enrollment, consistent
with prior projects in Romania, 20% attrition is assumed by the final follow-up at 6 months
after birth (100 vs. 100). To evaluate the effectiveness of the intervention, initially
unadjusted comparisons of the outcomes in intervention vs. the control groups will be
performed. Regression analyses will be used to adjust for group dissimilarities when
differences have p-values less than 0.10. A cost-benefit analysis of the intervention will
also be performed. The intervention costs will be compared to the health benefits derived
from increased mother abstinence rates, increased father quit rates, and reduced family
exposure to tobacco smoke. The health benefits will be monetized using estimates available
in the research literature. In addition, economic analyses will be presented for various
scenarios in which the proposed intervention can be integrated and sustained in the existing
Romanian health system.
Objective 3. Assess the extent of postpartum smoking relapse and associated risk factors
among women who spontaneously quit smoking during pregnancy.
Participants. To assemble a larger sample of women who quit smoking during pregnancy, 175
additional women are recruited during the delivery hospital stay, for a total of 300 (125
from Objective 2 + 175) women not subjected to the intervention. For consistency, they are
offered the same self-help materials, brief advice, and gift certificate incentives (see
Objective 2).
Outcomes and maternal characteristics. Postpartum maternal abstinence at 6 months postpartum
are the main outcome of interest. A secondary outcome of interest is the maternal number of
cigarettes smoked postpartum. Associations with all the maternal characteristics described
above will be explored(see Objective 2), with a particular focus on the mental health, the
nicotine dependence before quitting, breast feeding, and having a partner who smokes.
Analytical plan. Descriptive and multivariate analyses will be used to compare the women who
relapse to the ones who remain abstinent. Descriptive analyses (counts and percentages) will
assess the extent of postpartum smoking relapse and explore unadjusted associations between
various characteristics and risk factors of the women and their postpartum smoking status:
abstinent vs. relapsed. Multivariate logistic analyses will uncover the independent,
adjusted, effects of individual and interacted factors, statistically adjusting for the
effects of all other variables included in the analysis.
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