Strategies to Avoid Returning to Smoking (STARTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00757068|
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : May 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Behavioral: CBT addressing postpartum mood and weight concerns Behavioral: Supportive Behavioral Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Active Comparator: SBT
Women assigned to SBT (blue) will receive a six month program that offers to help them stay quit after having a baby.
Behavioral: Supportive Behavioral Therapy
Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. A non-specific, supportive condition will be delivered to women who want to remain smoke-free after they give birth.
Women assigned to CBT (pink) will receive a six month treatment designed to provide support and address the concerns of women who have just had a baby and do not want to resume smoking.
Behavioral: CBT addressing postpartum mood and weight concerns
Women will be assigned an individual counselor who will meet with them face-to-face six times and telephone them seven times. In these treatment sessions, the counselor will address postpartum mood and weight concerns.
- Abstinence at 12 months postpartum [ Time Frame: through 12 months ]
- Explore factors associated with abstinence postpartum. [ Time Frame: 0-12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757068
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Michele D Levine, PhD||University of Pittsburgh|