Smoking CessationPPCCNCT01684592
Phone-Based Postpartum Continuing Care for Smoking Cessation
A study testing Phone-based postpartum continuing care in people with Smoking Cessation and Pregnancy, run by Battelle Memorial Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Pregnancy
- What is being tested?
- Phone-based postpartum continuing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maryland Women's Center
Baltimore, Maryland, 21201
Chestnut Global Partners
Bloomington, Illinois, 61701
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Pregnancy
- Being tested
- Phone-based postpartum continuing care, Standard care
- Keywords
- smoking cessation, relapse prevention, pregnancy, postpartum
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone-based postpartum continuing careBehavioural
Also called PPCC
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.
Standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) Receives: Behavioral: Standard care |
| Standard care plus PPCC | Experimental | Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum Receives: Behavioral: Phone-based postpartum continuing care; Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Tobacco Products Per Day
Self-reported number of tobacco products smoked per day
Measured: 6 months postpartum
Secondary outcomes (6)
Number of Tobacco Products Per Day
Self-reported number of tobacco products smoked per day
Measured: 3 months postpartum
Past 90-day Tobacco Use
Self-reported number of days smoked in past 90 days
Measured: 3 months postpartum
Past 90-day Tobacco Use
Self-reported number of days smoked tobacco in past 90 days.
Measured: 6 months postpartum
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.
Measured: Baby's birth to 6 months postpartum
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.
Measured: Baby's birth to 6 months postpartum
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.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Chestnut Health Systems
- Responsible party
- Principal investigator, Victoria H. Coleman-Cowger, Battelle Memorial Institute
- Investigators
- Victoria H Coleman-Cowger, PhD, Principal investigator, Battelle Memorial InstituteKatrina Mark, MD, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684592
- Sponsor's protocol ID
- 1R34DA032683-01A1
- Acronym
- PPCC
- Status last verified
- Feb 2018
- First submitted
- 11 Sep 2012
- Last updated
- 13 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.
Publications
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.
PubMed 21710186
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy
- ClinicalTrials.gov ID
- NCT01684592
- Acronym / sponsor ID
- PPCC / 1R34DA032683-01A1
- Conditions
- Smoking Cessation, Pregnancy
- Keywords
- smoking cessation, relapse prevention, pregnancy, postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Collaborators
- University of Maryland, Chestnut Health Systems
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Posted 13 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard careStandard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive) |
| Standard care plus PPCC | Experimental | Behavioral: Phone-based postpartum continuing care, Behavioral: Standard careStandard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone-based postpartum continuing careAlso: PPCCPPCC 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. | Behavioural | Standard care plus PPCC |
| Standard careAll 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. | Behavioural | Standard care, Standard care plus PPCC |
Primary outcome
Number of Tobacco Products Per Day
Time frame: 6 months postpartum
Self-reported number of tobacco products smoked per day
6 secondary outcomes
Number of Tobacco Products Per Day
Time frame: 3 months postpartum
Past 90-day Tobacco Use
Time frame: 3 months postpartum
Past 90-day Tobacco Use
Time frame: 6 months postpartum
Times Mother Smoked While Breastfeeding
Time frame: Baby's birth to 6 months postpartum
Times Mother Smoked in the Room With Infant
Time frame: Baby's birth to 6 months postpartum
NicCheck Test Results for Cotinine Level From Infant Urine
Time frame: 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21710186Coleman-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.
- Individual participant dataSharing planned: No. Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria H Coleman-Cowger, PhD principal investigator
Battelle Memorial Institute
Katrina Mark, MD study director
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone-based postpartum continuing care in people with Smoking Cessation and Pregnancy, run by Battelle Memorial Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Tobacco Products Per Day (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018; AzTrials last refreshed its copy on 27 Oct 2026.