Clinical trial NCT00181909: Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Smoking Cessation
Keywords: Pregnancy
Smoking cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2005-09-16
Enrollment: 434
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.

Detailed description: A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (\>50%) reduction in daily cigarette use.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* current cigarette smoker (smoked \>1 cigarette in the past 7 days)
* 18 years old or older
* Willing to consider altering their smoking behavior during their pregnancy

Exclusion Criteria:

* More than 26 weeks' gestation at study entry
* No telephone access
* Not planning to live in New England for 1 year
* Unable to read and speak English

Primary outcomes:
measure: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
Secondary outcomes:
measure: Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
measure: Self-reported significant (>50%) reduction in tobacco use
measure: Quit attempt of >24 hours duration from enrollment to end of pregnancy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Tufts Health Plan
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Elyse R Park, PhD
role: STUDY_DIRECTOR
References:
citation: Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. doi: 10.1097/01.AOG.0000218100.05601.f8.
citation: Park ER, Quinn VP, Chang Y, Regan S, Loudin B, Cummins S, Perry K, Rigotti NA. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. Prev Med. 2007 Mar;44(3):223-9. doi: 10.1016/j.ypmed.2006.10.008. Epub 2007 Jan 3.