The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.
Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. This study aims to evaluate a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot randomized control trial will evaluate feasibility and acceptability of the intervention and compare the intervention to a standard of care control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Participants will be given 50mg/day of Naltrexone for 4 months.
Participants will be given 300mg/day of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon/early evening).
Participants will receive cognitive-behavioral therapy for weight loss and smoking cessation. Participants will meet with their assigned study clinician weekly for 60 minutes for 4 months.
Yale University
New Haven, Connecticut, United States
Study enrollment to assess Feasibility
Number of participants enrolled out of participants screened.
Time frame: 16 weeks
Mean number treatment sessions attended to assess Feasibility
Mean number of treatment sessions attended.
Time frame: 16 weeks
Retention to assess Feasibility
Retention will be measured as the percent of participants that attend the post treatment assessment.
Time frame: 16 weeks
Treatment credibility to assess Acceptability
Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility).
Time frame: Week 4, Week 8, Week 12, Week 16
Treatment satisfaction to assess Acceptability
Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction).
Time frame: Week 16
Percent weight change
Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
Time frame: Baseline, Week 16, 6-month follow-up
Smoking cessation, as measured by exhaled carbon monoxide
Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
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Smoking cessation, as measured by timeline followback interview
Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence
The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence.
Time frame: Baseline, Week 16, 6-month follow-up
Depressive symptomatology, as measured by the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Time frame: Baseline, Week 16, 6-month follow-up
Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)
GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.
Time frame: Baseline, Week 16, 6-month follow-up
Bariatric surgery completion
Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.
Time frame: 6-month follow-up