Phone-Based Postpartum Continuing Care for Smoking Cessation

Not Applicable

Completed

Conditions: Smoking Cessation
Pregnancy

Interventions: Behavioral: Standard care
Behavioral: Phone-based postpartum continuing care

Registration Number: NCT01684592

Lead Sponsor: Battelle Memorial Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 130

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
Standard care plus PPCC	Standard care	Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
Standard care plus PPCC	Phone-based postpartum continuing care	Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum

Primary Outcome Measures

Name	Time	Method
Number of Tobacco Products Per Day	6 months postpartum	Self-reported number of tobacco products smoked per day

Secondary Outcome Measures

Name	Time	Method
Number of Tobacco Products Per Day	3 months postpartum	Self-reported number of tobacco products smoked per day
Past 90-day Tobacco Use	6 months postpartum	Self-reported number of days smoked tobacco in past 90 days.
Times Mother Smoked While Breastfeeding	Baby's birth to 6 months postpartum	Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.
Times Mother Smoked in the Room With Infant	Baby's birth to 6 months postpartum	Based on the number of days of smoking in the same room with infant in the past 90.
NicCheck Test Results for Cotinine Level From Infant Urine	6 months postpartum	Infant urine was collected at 6 months postpartum using the "cotton roll" method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between "low" (score 1-6) versus "high" (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers.