Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

Smoking Cessation Clinical Trial

Official title: Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain

Status Completed

Clinical Trial Summary

The purpose of this research study is to better understand (1) why people gain weight when they quit smoking and (2) whether certain types of smoking cessation (i.e. quit smoking) counseling combined with the nicotine patch help people quit smoking and gain less weight.

Clinical Trial Description

This is a randomized clinical trial of the efficacy of a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+) plus transdermal nicotine (TN) compared to standard smoking cessation counseling (SC) plus TN in treatment-seeking smokers. After completing an Intake Visit (~week -3), eligible smokers will be randomized (stratified by nicotine dependence, BMI and gender) to participate in 8 individual sessions of BAS+ or SC over a 10-week treatment period with two sessions prior to the target quit date (weeks -2, -1) and six sessions post-target quit date (TQD [week 0] and weeks 1, 2, 4, 6, and 8). Standard, 8-week; open-label TN will begin on the TQD. Moderators will be assessed pre-treatment. Mediating mechanisms will be assessed before, during, and at the end of treatment (EOT, week 8). Smoking will be assessed by self-report and biochemically confirmed (Carbon Monoxide [CO] < 5) at all in-center visits after quitting, at EOT (week 8), and at the 12- and 26-week follow-ups. Weight will be assessed at these same time points. Food intake will be measured by three consecutive days of 24-hour food recalls at Baseline [week -2] and 4-, 8-, and 12- and 26-weeks post-TQD. Smoking cessation and post-cessation weight gain (PCWG) are the primary outcomes and food intake is a secondary outcome at 26-weeks post-TQD. Consistent with intent-to-treat (ITT) analyses, the investigators will measure smoking cessation and weight gain in the full sample at the 26-week follow-up, evaluating a smoking status by treatment interaction for the PCWG analysis. ;

Related Conditions & MeSH terms

• Body Weight
• Smoking Cessation
• Weight Gain
• Weight Loss

• NCT number: NCT02906787
• Study type: Interventional
• Source: Abramson Cancer Center at Penn Medicine
• Status: Completed
• Phase: N/A
• Start date: September 13, 2016
• Completion date: February 28, 2021