Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310115
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2006-03-29
Brief Title:
Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Smoking Relapse Prevention Among Postpartum Women
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Motivational counseling may help prevent pregnant women from smoking again after pregnancy
PURPOSE This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy
PURPOSE This randomized clinical trial is studying three different types of counseling to see how well they work in preventing smoking relapse after pregnancy in pregnant women who quit smoking during pregnancy
Detailed Description:
OBJECTIVES
Develop and evaluate 2 Motivational Relapse Prevention MRP treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy
Assess MRP and Enhanced MRP MRP effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP effects on abstinence
Assess the cost-effectiveness of both the MRP and MRP treatments relative to each other and to usual care for reducing postpartum smoking relapse
OUTLINE This is a randomized study Participants are randomized to 1 of 3 intervention arms
Arm I usual care UC Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline
Arm II motivational relapse prevention MRP Participants receive the same intervention as in arm I Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2 4 7 and 16 weeks postpartum
Arm III enhanced MRP MRP Participants receive the same intervention as in arm I and telephone counseling as in arm II Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum
Participants in all arms complete questionnaires at baseline at 30-33 weeks gestation and then at 8 and 26 weeks postpartum
Participants are followed at 8 and 26 weeks postpartum
PROJECTED ACCRUAL A total of 450 participants will be accrued for this study
Develop and evaluate 2 Motivational Relapse Prevention MRP treatments of varying intensity for reducing postpartum smoking relapse among pregnant women who quit smoking during pregnancy
Assess MRP and Enhanced MRP MRP effects on treatment mechanisms and the role of those mechanisms in mediating MRP and MRP effects on abstinence
Assess the cost-effectiveness of both the MRP and MRP treatments relative to each other and to usual care for reducing postpartum smoking relapse
OUTLINE This is a randomized study Participants are randomized to 1 of 3 intervention arms
Arm I usual care UC Participants receive self-help materials and brief relapse prevention advice based on the Treating Tobacco Use and Dependence Clinical Practice Guideline
Arm II motivational relapse prevention MRP Participants receive the same intervention as in arm I Participants also undergo telephone counseling over 30 minutes at 34 and 36 weeks gestation and then at 2 4 7 and 16 weeks postpartum
Arm III enhanced MRP MRP Participants receive the same intervention as in arm I and telephone counseling as in arm II Participants also undergo in-person counseling over 1 hour at 30-33 weeks gestation and then at 8 weeks postpartum
Participants in all arms complete questionnaires at baseline at 30-33 weeks gestation and then at 8 and 26 weeks postpartum
Participants are followed at 8 and 26 weeks postpartum
PROJECTED ACCRUAL A total of 450 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-01136 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA016672 |
| R01CA089350 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-BS01-178 | OTHER | None | None |
| CDR0000466327 | REGISTRY | None | None |