Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain
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|ClinicalTrials.gov Identifier: NCT02906787|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Weight Loss||Behavioral: BAS+ Behavioral: SC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain|
|Actual Study Start Date :||August 31, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
Placebo Comparator: SC
Participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
- Weight Change [ Time Frame: Through Study Completion (Intake Visit, Baseline Visit, Pre-Quit Visit , Target Quit Date Visit, Mid-Tx. 1 Visit, Mid-Tx 2 Visit, Mid-Tx 3 Visit, Mid-Tx 4 Visit , End of Treatment, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) ]Weight will be measured by a physician's scale (pounds) at the beginning of every in-person visit through study completion. Participants will be wearing light clothing without shoes. Pre-cessation weight will be computed as the average of weights at the Intake and Baseline Visits prior to any change in smoking behavior. Weight change from Baseline to the 26-week follow-up will serve as a primary weight outcome variable.
- Smoking Cessation [ Time Frame: Through Study Completion (End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) ]Smoking abstinence (primary outcome) will be assessed and biochemically verified at the End of Treatment Visit (week 8), at 12 and 26 weeks after the target quit date. The primary smoking outcome variable will be 7-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) biochemically verified by CO < 5 ppm at End of Treatment (week 8), and by saliva cotinine < 15ng/ml at the 12- and 26-week follow-up.
- Food Intake [ Time Frame: Through Study Completion (Baseline Visit, Mid-Tx 3 Visit, End of Treatment Visit, 12-Week Follow-Up Visit, and 26-Week Follow-Up Visit) ]Food intake (secondary outcome) will be assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week and 26-week follow-up Visits (n=15). A trained member of the research staff will use a multi-pass method with an interactive computerized software program, the Automated Self-Administered 24-hour Recall (ASA24®), to determine total kcal/day (outcome variable).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906787
|Contact: Benjamin F Albelda, B.S.||email@example.com|
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Benjamin Albelda, B.S. 215-746-7173 firstname.lastname@example.org|
|Contact: Kristin Kristin Tederstrom, B.A. 215-746-7142 email@example.com|
|Principal Investigator:||Janet Audrain-McGovern, Ph.D.||Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania|