Telephone Counseling for Pregnant Smokers
Condition: Smoking
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Telephone counseling; Self-help materials
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: telephone counseling