Phone-Based Postpartum Continuing Care for Smoking Cessation



Status:Completed
Conditions:Smoking Cessation, Women's Studies
Therapuetic Areas:Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:October 2012
End Date:March 2015

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Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy

Smoking is a leading cause of death and other negative health outcomes. While a high
percentage of women quit smoking during pregnancy, the majority relapse in the first 6 months
postpartum. We propose developing and pilot testing a phone-based postpartum continuing care
(PPCC) protocol based on existing evidence-based approaches to increase smoking cessation,
reduce relapse, increase early re-intervention, and reduce infant exposure to environmental
tobacco smoke in the postpartum period.

The large majority of women who quit smoking during pregnancy relapse in the first six months
postpartum, highlighting a need for effective postpartum continuing care that supports women
through the challenging postpartum period when stress is high and motivation to stay quit may
decline. Existing relapse prevention interventions (typically delivered during pregnancy)
have been found to be of little benefit during the postpartum period, suggesting the need for
a more formal continuing care approach. Phone-based protocols for smoking cessation have been
widely disseminated and effective because they address the need for flexible access, but are
passive and not typically utilized by women in the postpartum period.

The proposed pilot study will develop and test a Phone-based Postpartum Continuing Care
(PPCC) model that draws from existing evidence-based protocols--the 5 A's and Recovery
Management Checkups (RMC)-- shown to be effective with other populations. The experimental
PPCC will reinforce the importance of abstinence, relapse prevention, and reduced smoking
through proactive re-intervention (i.e., RMC) with the 5 A's at times when postpartum women
are more likely to relapse, and provide education and monitoring of the infant's direct and
indirect exposure to nicotine through breastfeeding and secondhand smoke. We will evaluate
PPCC's effectiveness relative to a passive referral to a 24/7 hotline, which is current
standard care.

Approximately one hundred thirty women in their first or second trimester of pregnancy who
were nicotine-dependent in the past year, currently smoke, or quit within the past 90 days
will be recruited at their first prenatal appointment at the Maryland Women's Center (MWC) in
Baltimore, Maryland. All women will receive the clinic's standard of care for smoking
cessation--the 5 A's --during pregnancy from their physician. Half will be randomly assigned
to an experimental group getting PPCC for 6 months postpartum and half to a control group
receiving only a referral to a passive 24/7 state quit line postpartum. It is expected that
in the 6 months following childbirth women in the experimental PPCC (relative to those in the
control group) will: a) smoke fewer cigarettes, b) smoke fewer days, c) go longer before
postpartum relapse, d) have less time between relapse and talking to a health professional
about smoking, e) have less time between relapse and resumption of abstinence , f) smoke
fewer times while breastfeeding, g) smoke fewer times while in the same room as the infant,
and h) reduce their infant's cotinine levels.

The aims of this pilot project are to develop PPCC from existing evidence-based approaches,
demonstrate the feasibility of implementing the PPCC intervention with at least 80%
compliance and at least 80% follow-up at each wave, and evaluate the effect size associated
with receiving standard care vs. standard care + PPCC in order to understand the promise of
and appropriate power required for a larger clinical trial.

Inclusion Criteria:

- first or second trimester of pregnancy

- age 18 or older

- self-reported tobacco use in the past 90 days or nicotine-dependence in the past year

Exclusion Criteria:

- intend to terminate their pregnancy

- intend to move out of the city within the next 12 months

- are unable to provide informed consent and participate in English
We found this trial at
2
sites
Bloomington, Illinois 61701
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Bloomington, IL
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Baltimore, Maryland 21201
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Baltimore, MD
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