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Phone-Based Postpartum Continuing Care for Smoking Cessation (PPCC)

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ClinicalTrials.gov Identifier: NCT01684592
Recruitment Status : Completed
First Posted : September 13, 2012
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of Maryland
Chestnut Health Systems
Information provided by (Responsible Party):
Victoria H. Coleman-Cowger, 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Pregnancy Behavioral: Phone-based postpartum continuing care Behavioral: Standard care Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phone-Based Postpartum Continuing Care: Smoking Cessation Beginning in Pregnancy
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard care
Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)
Behavioral: 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 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.
Experimental: Standard care plus PPCC
Standard care for smoking during pregnancy and proactive phone-based postpartum continuing care (PPCC) for 6 months postpartum
Behavioral: 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.
Other Name: PPCC
Behavioral: 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 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.



Primary Outcome Measures :
  1. Number of Tobacco Products Per Day [ Time Frame: 6 months postpartum ]
    Self-reported number of tobacco products smoked per day


Secondary Outcome Measures :
  1. Number of Tobacco Products Per Day [ Time Frame: 3 months postpartum ]
    Self-reported number of tobacco products smoked per day

  2. Past 90-day Tobacco Use [ Time Frame: 3 months postpartum ]
    Self-reported number of days smoked in past 90 days

  3. Past 90-day Tobacco Use [ Time Frame: 6 months postpartum ]
    Self-reported number of days smoked tobacco in past 90 days.

  4. Times Mother Smoked While Breastfeeding [ Time Frame: 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.

  5. Times Mother Smoked in the Room With Infant [ Time Frame: 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.

  6. NicCheck Test Results for Cotinine Level From Infant Urine [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684592


Locations
United States, Illinois
Chestnut Global Partners
Bloomington, Illinois, United States, 61701
United States, Maryland
Maryland Women's Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Battelle Memorial Institute
University of Maryland
Chestnut Health Systems
Investigators
Principal Investigator: Victoria H Coleman-Cowger, PhD Battelle Memorial Institute
Study Director: Katrina Mark, MD University of Maryland
  Study Documents (Full-Text)

Documents provided by Victoria H. Coleman-Cowger, Battelle Memorial Institute:
Informed Consent Form  [PDF] September 18, 2014
Study Protocol  [PDF] May 28, 2013


Publications:
Responsible Party: Victoria H. Coleman-Cowger, Principal Research Scientist, Battelle Memorial Institute
ClinicalTrials.gov Identifier: NCT01684592     History of Changes
Other Study ID Numbers: 1R34DA032683-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2012    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Researchers may request de-identified aggregate data in 2017 via email from the PI of record by submitting a formal request with desired variables.

Keywords provided by Victoria H. Coleman-Cowger, Battelle Memorial Institute:
smoking cessation
relapse prevention
pregnancy
postpartum