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| Name | Class |
|---|---|
| American Society for Metabolic and Bariatric Surgery | OTHER |
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The purpose of this research study is to develop and pilot a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery.
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. Pre-bariatric surgery patients would significantly benefit from a tailored multiple health behavior change intervention targeting weight loss and smoking cessation concurrently, yet no such interventions have been examined within this patient population.
This study aims to develop and pilot 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 will evaluate the feasibility and acceptability of the intervention, as well as use a mixed methods approach for intervention refinement. Weight loss and smoking cessation will be assessed post-treatment. This study will provide important preliminary data needed to develop an effective intervention that will address weight loss and smoking cessation concurrently, which is needed to improve bariatric surgery utilization and reduce risk for smoking relapse post-surgery for this high-risk patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will receive the multiple health behavior change intervention with combined medication (Naltrexone 50mg/day; Bupropion Extended Release 300mg/day) and behavior therapy (Cognitive-Behavioral Therapy) for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone Hydrochloride | Drug | Participants will be given 50mg/day of Naltrexone for 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study enrollment to assess Feasibility | Number of participants enrolled out of participants screened | 16 weeks |
| Mean number treatment sessions attended to assess Feasibility | Mean number of treatment sessions attended | 16 weeks |
| Retention to assess Feasibility | Retention will be measured as the percent of participants that attend the post treatment assessment | 16 weeks |
| Treatment credibility and satisfaction to assess Acceptability | Treatment credibility and satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is acceptable. | 16 weeks |
| Percent weight change | Percent weight change will be calculated from baseline to post-treatment. | Baseline and Week 16 |
| Smoking cessation, as measured by exhaled carbon monoxide | Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration. | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Smoking cessation, as measured by timeline followback interview | Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin E Smith, PhD | Contact | 203-785-7210 | smithcai@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Caitlin E Smith, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32524412 | Background | Chow A, Neville A, Kolozsvari N. Smoking in bariatric surgery: a systematic review. Surg Endosc. 2021 Jun;35(6):3047-3066. doi: 10.1007/s00464-020-07669-3. Epub 2020 Jun 10. |
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All participants will receive the intervention.
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| Bupropion HCl Extended Release | Drug | 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). |
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| Cognitive-Behavioral Therapy | Behavioral | 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. |
|
| Baseline, Week 4, Week 8, Week 12, Week 16 |
| Baseline and Week 16 |
| 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. | Baseline and Week 16 |
| 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 calcualed in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week. | Baseline and Week 16 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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