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Phone-Based Postpartum Continuing Care for Smoking Cessation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684592
Acronym
PPCC
Enrollment
130
Registered
2012-09-13
Start date
2012-10-31
Completion date
2015-03-31
Last updated
2018-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Smoking Cessation

Keywords

smoking cessation, relapse prevention, pregnancy, postpartum

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.

Interventions

BEHAVIORALPhone-based postpartum continuing care

PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.

BEHAVIORALStandard care

All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.

Sponsors

University of Maryland
CollaboratorOTHER
Chestnut Health Systems
CollaboratorOTHER
Battelle Memorial Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Tobacco Products Per Day6 months postpartumSelf-reported number of tobacco products smoked per day

Secondary

MeasureTime frameDescription
Number of Tobacco Products Per Day3 months postpartumSelf-reported number of tobacco products smoked per day
Past 90-day Tobacco Use3 months postpartumSelf-reported number of days smoked in past 90 days
Times Mother Smoked While BreastfeedingBaby's birth to 6 months postpartumBased 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 InfantBaby's birth to 6 months postpartumBased 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 Urine6 months postpartumInfant 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.

Countries

United States

Participant flow

Recruitment details

The sample was drawn from a population of low-income pregnant women attending their first prenatal visit at an obstetrics clinic in Baltimore, MD. In total, 790 women (i.e., smokers and non-smokers) were assessed for eligibility from March-December 2013, with 180 meeting eligibility criteria. Of those screened, 130 participants were enrolled.

Pre-assignment details

Randomization occurred at week 26 gestation, after intake data was collected.

Participants by arm

ArmCount
Standard Care
Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) Standard care: All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by ACOG for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
64
Standard Care Plus PPCC
Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum Phone-based postpartum continuing care: PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.
64
Total128

Baseline characteristics

CharacteristicStandard CareTotalStandard Care Plus PPCC
Age, Continuous25.6 years
STANDARD_DEVIATION 4.7
26.0 years
STANDARD_DEVIATION 5
26.3 years
STANDARD_DEVIATION 5.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
53 Participants103 Participants50 Participants
Race (NIH/OMB)
More than one race
4 Participants5 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants20 Participants13 Participants
Region of Enrollment
United States
64 participants128 participants64 participants
Sex: Female, Male
Female
64 Participants128 Participants64 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 640 / 64
serious
Total, serious adverse events
5 / 640 / 64

Outcome results

Primary

Number of Tobacco Products Per Day

Self-reported number of tobacco products smoked per day

Time frame: 6 months postpartum

ArmMeasureValue (MEAN)
Standard CareNumber of Tobacco Products Per Day6.4 tobacco products
Standard Care Plus PPCCNumber of Tobacco Products Per Day6.9 tobacco products
Secondary

NicCheck Test Results for Cotinine Level From Infant Urine

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.

Time frame: 6 months postpartum

ArmMeasureValue (MEAN)Dispersion
Standard CareNicCheck Test Results for Cotinine Level From Infant Urine0 units on a scaleStandard Deviation 0
Standard Care Plus PPCCNicCheck Test Results for Cotinine Level From Infant Urine0 units on a scaleStandard Deviation 0
Secondary

Number of Tobacco Products Per Day

Self-reported number of tobacco products smoked per day

Time frame: 3 months postpartum

ArmMeasureValue (MEAN)
Standard CareNumber of Tobacco Products Per Day7.1 tobacco products
Standard Care Plus PPCCNumber of Tobacco Products Per Day7.9 tobacco products
Secondary

Past 90-day Tobacco Use

Self-reported number of days smoked tobacco in past 90 days.

Time frame: 6 months postpartum

ArmMeasureValue (MEAN)
Standard CarePast 90-day Tobacco Use59.2 days
Standard Care Plus PPCCPast 90-day Tobacco Use55.3 days
Secondary

Past 90-day Tobacco Use

Self-reported number of days smoked in past 90 days

Time frame: 3 months postpartum

ArmMeasureValue (MEAN)
Standard CarePast 90-day Tobacco Use60.7 days
Standard Care Plus PPCCPast 90-day Tobacco Use57.5 days
Secondary

Times Mother Smoked in the Room With Infant

Based on the number of days of smoking in the same room with infant in the past 90.

Time frame: Baby's birth to 6 months postpartum

Population: Only current smokers responded to this question

ArmMeasureValue (MEAN)Dispersion
Standard CareTimes Mother Smoked in the Room With Infant.70 number of days smokedStandard Deviation 3.5
Standard Care Plus PPCCTimes Mother Smoked in the Room With Infant.06 number of days smokedStandard Deviation 0.3
Secondary

Times Mother Smoked While Breastfeeding

Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.

Time frame: Baby's birth to 6 months postpartum

Population: Only 7 women reported having breastfed at 6 month postpartum

ArmMeasureValue (MEAN)Dispersion
Standard CareTimes Mother Smoked While Breastfeeding7.13 times smoked in past 90 daysStandard Deviation 4.6
Standard Care Plus PPCCTimes Mother Smoked While Breastfeeding0 times smoked in past 90 daysStandard Deviation 0

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026