Telephone Counseling for Pregnant Smokers

Smoking Clinical Trial

Official title:

Telephone Counseling for Pregnant Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144883
• Other study ID #: IRB #030310
• Status: Completed
• Phase: Phase 3
• Start date: September 2000
• Est. completion date: April 2004

Study information

• Verified date: February 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1173
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Telephone counseling
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
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.

Locations

Country	Name	City	State
United States	University of California San Diego California Smokers' Helpline	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Partnership for Smoke-Free Families (PSF)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of smokers making a 24-hour quit attempt	During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.	<36 weeks gestation
Secondary	Relapse curve based on quit attempt	Kaplan-Meier analysis on the quit attempts over a 6 month period.	Seven months post enrollment
Secondary	Percentage of smokers making a 24-hour quit attempt	During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.	2-months postpartum
Secondary	Percentage of smokers making a 24-hour quit attempt	During evaluation call subjects were asked if they had made a quit attempt that lasted at least 24 hours.	6-months postpartum
Secondary	7-day cotinine verified abstinence	Subjects were asked to submit a saliva sample. This sample was sent to a laboratory to test the cotinine level.	<36 weeks gestation
Secondary	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.; Safety Issue? (FDAAA) No	<36 weeks gestation
Secondary	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.; Safety Issue? (FDAAA) No	2-months postpartum