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Completed

NCT Number: NCT02144883

Telephone Counseling for Pregnant Smokers

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Diego California Smokers' Helpline

San Diego, California, 92111, United States

About this study

Smoking during pregnancy increases the risk of low birth weight, premature delivery, fetal and infant death, and children's developmental problems. It is also associated with significant economic costs. Telephone cessation quitlines have been suggested as one good way to reach pregnant smokers.

This randomized controlled trial was embedded into a free statewide telephone cessation quitline in California. The primary component of the intervention was telephone counseling using a structured protocol developed specifically for the pregnant population. The counseling consisted of nine counseling sessions.

A secondary component of the intervention was the mailed materials. Following enrollment in the study all subjects (control and intervention) 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.

Prior to 36 weeks gestation (in the third trimester), 2-months postpartum, and 6-months postpartum we conducted a brief telephone survey to assess smoking status. The information obtained allowed us to determine 30-day prolonged abstinence rates.

Prior to 36 weeks gestation (in the third trimester), the investigators sent a kit and requested saliva samples be mailed back to biochemically verify smoking status by testing for cotinine and nicotine byproducts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 30 days prolonged abstinence

    Time frame: 6-months postpartum

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

Secondary outcomes

  1. Percentage of smokers making a 24-hour quit attempt

    Time frame: <36 weeks gestation

    During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.

  2. Relapse curve based on quit attempt

    Time frame: Seven months post enrollment

    Kaplan-Meier analysis on the quit attempts over a 6 month period.

  3. Percentage of smokers making a 24-hour quit attempt

    Time frame: 2-months postpartum

    During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.

  4. Percentage of smokers making a 24-hour quit attempt

    Time frame: 6-months postpartum

    During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.

  5. 7-day cotinine verified abstinence

    Time frame: <36 weeks gestation

    Subjects were asked to submit a saliva sample. This sample was sent to a laboratory to test the cotinine level.

  6. 30 days prolonged abstinence

    Time frame: <36 weeks gestation

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

    Safety Issue? (FDAAA) No

  7. 30 days prolonged abstinence

    Time frame: 2-months postpartum

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

    Safety Issue? (FDAAA) No

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Partnership for Smoke-Free Families (PSF)

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
May 22, 2014
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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