Telephone Counseling for Pregnant Smokers

NCT02144883 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1173

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

  • Smoking

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Shu-Hong Zhu, Ph.D. · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2004-04-30
Completion
2004-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144883 on ClinicalTrials.gov