Phone-Based Postpartum Continuing Care for Smoking Cessation

NCT01684592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2018-03-13

Study results available
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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.

Conditions

  • Smoking Cessation
  • Pregnancy

Interventions

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.

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.

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER
  • Chestnut Health Systems

    collaborator OTHER
  • Battelle Memorial Institute

    lead OTHER

Principal Investigators

  • Victoria H Coleman-Cowger, PhD · Battelle Memorial Institute

  • Katrina Mark, MD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684592 on ClinicalTrials.gov