Phone-Based Postpartum Continuing Care for Smoking Cessation

NCT01684592 | Completed Results DMC

• 1 other identifier: 1R34DA032683-01A1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation; Pregnancy

Keywords

smoking cessation; relapse prevention; pregnancy; postpartum

Outcome Measures

Primary Outcomes (1)

• Number of Tobacco Products Per Day

  Self-reported number of tobacco products smoked per day

  6 months postpartum

Secondary Outcomes (6)

• Number of Tobacco Products Per Day

  3 months postpartum

• Past 90-day Tobacco Use

  3 months postpartum

• Past 90-day Tobacco Use

  6 months postpartum

• Times Mother Smoked While Breastfeeding

  Baby's birth to 6 months postpartum

• Times Mother Smoked in the Room With Infant

  Baby's birth to 6 months postpartum

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Standard care for smokers during pregnancy and referral to 24/7 quitline postpartum (passive)

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

Behavioral: Phone-based postpartum continuing care; Behavioral: Standard care

Interventions

Phone-based postpartum continuing care BEHAVIORAL

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.

Also known as: PPCC

Standard care plus PPCC

Standard care BEHAVIORAL

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.

Standard care; Standard care plus PPCC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Battelle Memorial Institute: lead
• University of Maryland: collaborator
• Chestnut Health Systems: collaborator

Study Sites (2)

Chestnut Global Partners

Bloomington, Illinois, 61701, United States

Location

Maryland Women's Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 21710186 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Trend of Experimental group being heavier smokers than Control group; Difficulty contacting participants for PPCC calls (limited delivery of intervention).

Results Point of Contact

• Title: Dr. Victoria Coleman-Cowger
• Organization: Battelle

colemancowger@battelle.org

4103722748

Study Officials

• Victoria H Coleman-Cowger, PhD

  Battelle Memorial Institute

  PRINCIPAL INVESTIGATOR

• Katrina Mark, MD

  University of Maryland, Baltimore

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 13, 2018
• Results First Posted: March 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)