AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in United States

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.

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 groups in NCT01684592
Study groupRoleWhat they receive
Standard careActive comparatorStandard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
Receives: Behavioral: Standard care
Standard care plus PPCCExperimentalStandard 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.

  1. Number of Tobacco Products Per Day

    Self-reported number of tobacco products smoked per day

    Measured: 6 months postpartum

Secondary outcomes (6)
  1. Number of Tobacco Products Per Day

    Self-reported number of tobacco products smoked per day

    Measured: 3 months postpartum

  2. Past 90-day Tobacco Use

    Self-reported number of days smoked in past 90 days

    Measured: 3 months postpartum

  3. Past 90-day Tobacco Use

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

    Measured: 6 months postpartum

  4. 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

  5. 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

  6. 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.

  1. First posted13 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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)
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
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in