Clinical trial NCT01684592: Phone-Based Postpartum Continuing Care for Smoking Cessation
Official title: Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pregnancy
Keywords: smoking cessation
relapse prevention
pregnancy
postpartum
Lead sponsor: Battelle Memorial Institute
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Chestnut Health Systems
First posted: 2012-09-13
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Tobacco Products Per Day
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Number of Tobacco Products Per Day
timeFrame: 3 months postpartum
measure: Past 90-day Tobacco Use
timeFrame: 3 months postpartum
measure: Past 90-day Tobacco Use
timeFrame: 6 months postpartum
measure: Times Mother Smoked While Breastfeeding
timeFrame: Baby's birth to 6 months postpartum
measure: Times Mother Smoked in the Room With Infant
timeFrame: Baby's birth to 6 months postpartum
measure: NicCheck Test Results for Cotinine Level From Infant Urine
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Chestnut Global Partners
state: Illinois
city: Baltimore
country: United States
facility: Maryland Women's Center
state: Maryland
Study officials:
affiliation: Battelle Memorial Institute
name: Victoria H Coleman-Cowger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Katrina Mark, MD
role: STUDY_DIRECTOR
References:
citation: Coleman-Cowger VH. Smoking cessation intervention for pregnant women: a call for extension to the postpartum period. Matern Child Health J. 2012 Jul;16(5):937-40. doi: 10.1007/s10995-011-0837-2.