Clinical trial NCT02144883: Telephone Counseling for Pregnant Smokers
Official title: Telephone Counseling for Pregnant Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking
Keywords: telephone counseling
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Partnership for Smoke-Free Families (PSF)
First posted: 2014-05-22
Enrollment: 1173
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30 days prolonged abstinence
timeFrame: 6-months postpartum
Secondary outcomes:
measure: Percentage of smokers making a 24-hour quit attempt
timeFrame: <36 weeks gestation
measure: Relapse curve based on quit attempt
timeFrame: Seven months post enrollment
measure: Percentage of smokers making a 24-hour quit attempt
timeFrame: 2-months postpartum
measure: Percentage of smokers making a 24-hour quit attempt
timeFrame: 6-months postpartum
measure: 7-day cotinine verified abstinence
timeFrame: <36 weeks gestation
measure: 30 days prolonged abstinence
timeFrame: <36 weeks gestation
measure: 30 days prolonged abstinence
timeFrame: 2-months postpartum
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego California Smokers' Helpline
state: California
Study officials:
affiliation: UCSD
name: Shu-Hong Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.