Telephone Counseling for Pregnant Smokers

NCT02144883 | Completed Phase 3

• 1 other identifier: IRB #030310
• Study Type: interventional
• Target: 1,173
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of the study was to investigate the efficacy of telephone counseling to help pregnant women quit smoking. The investigators tested two hypotheses: 1) telephone counseling increases the overall cessation rate during pregnancy, and 2) the counseling effects can be maintained postpartum.

Conditions

Smoking

Keywords

telephone counseling

Outcome Measures

Primary Outcomes (1)

• 30 days prolonged abstinence

  Conducted a brief telephone survey to assess smoking status. The information obtained allowed us to determine 30-day prolonged abstinence rates.

  6-months postpartum

Secondary Outcomes (7)

• Percentage of smokers making a 24-hour quit attempt

  <36 weeks gestation

• Relapse curve based on quit attempt

  Seven months post enrollment

• Percentage of smokers making a 24-hour quit attempt

  2-months postpartum

• Percentage of smokers making a 24-hour quit attempt

  6-months postpartum

• 7-day cotinine verified abstinence

  <36 weeks gestation

Study Arms (2)

Materials

ACTIVE COMPARATOR

Self-help materials mailed to subjects home.

Behavioral: Self-help materials

Telephone Counseling and Materials

EXPERIMENTAL

Subjects received up to 9 telephone counseling calls plus self-help quit kit and 5 additional mailings

Behavioral: Telephone counseling; Behavioral: Self-help materials

Interventions

Telephone counseling BEHAVIORAL

Subjects randomized into the telephone counseling condition received one comprehensive pre-quit call lasting about 45 minutes; five follow-up calls during the pregnancy, scheduled according to the risk of relapse after the quit attempt (1, 3, 7, 14, and 30 days after the quit date) one 30-minute pre-birth call scheduled after 36 weeks gestation and two additional follow-up sessions scheduled for 14 and 28 days after the baby's birth. The counseling used a proactive calling procedure in that counselors made all the calls based on agreed-upon dates with the clients. This proactive approach aimed to foster a positive counseling relationship, provide accountability, and create opportunities to address wavering motivation, reduce attrition, and minimize relapse.

Telephone Counseling and Materials

Self-help materials BEHAVIORAL

All subjects received a self-help quit kit for pregnant smokers and fact sheets on second-hand smoke and additional tips for quitting while pregnant. Subjects in the counseling intervention group received five additional mailings. These mailings were designed to remind them of their commitment to quitting and of the presence of counseling support if they needed help. Mailings included a pamphlet on pregnancy facts, a refrigerator magnet with the quitline number, and a social support planning worksheet that were sent at 4.5 months, 6 months, and 7.5 months gestation, respectively. They also received a congratulatory card soon after the birth and a brochure with tips for parenting newborns that was sent at one month postpartum.

Materials; Telephone Counseling and Materials

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current smoker willing to quit within one month
• Recent quitters
• First time quitline caller
• Less than 27 weeks gestation
• English and/or Spanish speaking
• Valid phone number
• Valid address
• Gave consent to participate in study and evaluation

You may not qualify if:

• Active psychiatric disorder
• Substance or alcohol abuse
• Had been in recovery from alcohol or other substances for less than 6 months
• Planned to use pharmacotherapy
• Insufficient contact information

Sponsors & Collaborators

• University of California, San Diego: lead
• Partnership for Smoke-Free Families (PSF): collaborator

Study Sites (1)

University of California San Diego California Smokers' Helpline

San Diego, California, 92111, United States

Location

Related Publications (2)

• Cummins, S.E., Tedeschi, G.J., Anderson, C.M., Quinlan-Downs, R., Harris, P., Zhu, S.-H. (2007). Telephone counseling for pregnant smokers: essential elements. Journal of Smoking Cessation, 2(2), 36-46.

  BACKGROUND

• Cummins SE, Tedeschi GJ, Anderson CM, Zhu SH. Telephone Intervention for Pregnant Smokers: A Randomized Controlled Trial. Am J Prev Med. 2016 Sep;51(3):318-26. doi: 10.1016/j.amepre.2016.02.022. Epub 2016 Apr 4.

  PMID: 27056131 DERIVED

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shu-Hong Zhu, Ph.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2000
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

US (1)