Telephone Counseling for Pregnant Smokers
- Conditions
- Smoking
- Interventions
- Behavioral: Telephone counselingBehavioral: Self-help materials
- Registration Number
- NCT02144883
- Lead Sponsor
- University of California, San Diego
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1173
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telephone Counseling and Materials Self-help materials Subjects received up to 9 telephone counseling calls plus self-help quit kit and 5 additional mailings Materials Self-help materials Self-help materials mailed to subjects home. Telephone Counseling and Materials Telephone counseling Subjects received up to 9 telephone counseling calls plus self-help quit kit and 5 additional mailings
- Primary Outcome Measures
Name Time Method 30 days prolonged abstinence 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 Outcome Measures
Name Time Method Percentage of smokers making a 24-hour quit attempt 6-months postpartum During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.
Relapse curve based on quit attempt Seven months post enrollment Kaplan-Meier analysis on the quit attempts over a 6 month period.
7-day cotinine verified abstinence <36 weeks gestation Subjects were asked to submit a saliva sample. This sample was sent to a laboratory to test the cotinine level.
30 days prolonged abstinence 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
Trial Locations
- Locations (1)
University of California San Diego California Smokers' Helpline
🇺🇸San Diego, California, United States