Telephone Counseling for Pregnant Smokers

NCT ID: NCT02144883

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2004-04-30

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Materials

Self-help materials mailed to subjects home.

Group Type: ACTIVE_COMPARATOR

Self-help materials

Intervention Type: BEHAVIORAL

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.

Telephone Counseling and Materials

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

Group Type: EXPERIMENTAL

Telephone counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Partnership for Smoke-Free Families (PSF)

UNKNOWN

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Shu-Hong Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-Hong Zhu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California San Diego California Smokers' Helpline

San Diego, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 27056131 (View on PubMed)

Other Identifiers

IRB #030310

Identifier Type: -

Identifier Source: org_study_id