Telephone Counseling for Pregnant Smokers

University of California San Diego

Status and phase: Completed; Phase 3

Conditions: Smoking

Treatments: Behavioral: Self-help materials; Behavioral: Telephone counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02144883

IRB #030310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,173 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,173 participants in 2 patient groups

Materials

Active Comparator group

Description:

Self-help materials mailed to subjects home.

Treatment:

Behavioral: Self-help materials

Telephone Counseling and Materials

Experimental group

Description:

Subjects received up to 9 telephone counseling calls plus self-help quit kit and 5 additional mailings

Treatment:

Behavioral: Telephone counseling

Behavioral: Self-help materials