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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation counseling delivered by telephone | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum | ||
| Self-reported significant (>50%) reduction in tobacco use | ||
| Quit attempt of >24 hours duration from enrollment to end of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Rigotti, MD | Massachusetts General Hospital | Principal Investigator |
| Elyse R Park, PhD | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Tufts Health Plan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16816060 | Result | 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. | |
| 17204318 | Derived | 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. |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Waltham |
| Massachusetts |
| United States |