Motivational Counseling in Preventing Smoking Relapse After Pregnancy in Pregnant Women Who Quit Smoking During Pregnancy
Smoking Relapse Prevention Among Postpartum Women
6 other identifiers
observational
469
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 29, 2006
CompletedFirst Posted
Study publicly available on registry
April 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 23, 2016
September 1, 2016
14.3 years
March 29, 2006
September 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients with Smoking Abstinence
Smoking abstinence as measured by the Society for Research on Nicotine and Tobacco Smoking Status Measure at 26 weeks following study treatment
26 weeks
Secondary Outcomes (1)
Number of Cigarettes Smoked Daily
26 weeks following study treatment
Study Arms (3)
Smoking Prevention Usual Care
Arm I (usual care): Self-help materials and brief relapse prevention advice based on Treating Tobacco Use and Dependence Clinical Practice Guideline.
MRP
Arm II (motivational relapse prevention \[MRP\]): Same intervention as usual care, plus 30 minutes telephone counseling at 34 \& 36 weeks gestation then at 2, 4, 7, \& 16 weeks postpartum.
Enhanced MRP +
Arm III (enhanced MRP \[MRP+\]): Same intervention as usual care and telephone counseling as MRP, plus 1 hour in-person counseling at 30-33 weeks gestation \& 8 weeks postpartum.
Interventions
Usual care of self-help materials and advice for staying cigarette free
6 x 30 minute counseling sessions over the telephone
Eligibility Criteria
Women, 18 years of age or older, who quit smoking while pregnant.
You may qualify if:
- age 18 or older
- former smoker who quit during pregnancy as assessed via self-report
- smoked an average of greater than or equal to 1 cigarette per day during the year prior to the current pregnancy
- gestational age \< 33 weeks and ability to attend an in-person visit at University of Texas MD Anderson Cancer Center (UTMDACC) between 30-33 weeks of gestational age
- can speak, read and write in English.
- must have a functioning home or personal cell phone
You may not qualify if:
- \) high-risk pregnancy or known negative birth outcome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Wetter, PhD, BS, BA
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2006
First Posted
April 3, 2006
Study Start
April 1, 2002
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 23, 2016
Record last verified: 2016-09