A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Study enrollment to assess Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-65 years old.
- •Be actively considering bariatric surgery.
- •Smoke at least 5 cigarettes daily for the past 3 months.
- •Have a BMI ≥ 30.0 kg/m
- •Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines).
- •No history of medical conditions that are contraindicated with Naltrexone or - Bupropion (e.g., seizure disorders, uncontrolled hypertension, cardiac issues including history of heart attacks, heart disease, or stroke, history of anorexia or bulimia nervosa).
- •Physically well enough to participate in the intervention (e.g., able to walk independently).
- •Speak/read/write in English.
- •Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.
- •No active suicidal or homicidal ideation.
排除标准
- •Has an acute medical or psychiatric disorder that would make participation difficult or unsafe.
- •Has suicidal or homicidal ideation that requires immediate attention.
- •Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- •Has evidence of a second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram that would preclude safe participation.
- •Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute).
- •Has elevated bilirubin test or any other liver function test value > 5 times the upper limit of normal laboratory criteria.
- •Has a platelet count < 100x10 3/uL.
- •Has a history of anorexia nervosa or history of bulimia nervosa.
- •Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).
- •Has a history of allergy or sensitivity to Naltrexone or Bupropion.
- •Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression).
- •Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
- •Has current uncontrolled Type I or Type 2 diabetes mellitus.
- •Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder, including cancer.
- •Has angle closure glaucoma.
- •Has taken an investigational drug in another study within 30 days of study consent.
- •Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.
- •Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.
- •Is receiving ongoing treatment with tricyclic antidepressants, xanthines, systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous stimulants, or any medication that could interact adversely with the study medications.
- •Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.
- •Requires treatment with opioid-containing medications during the study period.
- •Has a surgery planned other than bariatric surgery.
- •Is currently in jail, prison, or any inpatient overnight facility as required by a court of law or have pending legal action or other legal situation that could prevent participation.
- •Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.
研究组 & 干预措施
MHBC Intervention Group
Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
干预措施: Naltrexone hydrochloride (Drug)
MHBC Intervention Group
Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
干预措施: Cognitive-Behavioral Therapy (Behavioral)
Control Group
Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.
MHBC Intervention Group
Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
干预措施: Bupropion Hydrochloride Extended-release (Drug)
结局指标
主要结局
Study enrollment to assess Feasibility
时间窗: 16 weeks
Number of participants enrolled out of participants screened.
Mean number treatment sessions attended to assess Feasibility
时间窗: 16 weeks
Mean number of treatment sessions attended.
Retention to assess Feasibility
时间窗: 16 weeks
Retention will be measured as the percent of participants that attend the post treatment assessment.
Treatment credibility to assess Acceptability
时间窗: Week 4, Week 8, Week 12, Week 16
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).
Treatment satisfaction to assess Acceptability
时间窗: Week 16
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).
Percent weight change
时间窗: Baseline, Week 16, 6-month follow-up
Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
Smoking cessation, as measured by exhaled carbon monoxide
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
Smoking cessation, as measured by timeline followback interview
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up
Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.
次要结局
- Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence(Baseline, Week 16, 6-month follow-up)
- Depressive symptomatology, as measured by the Patient Health Questionnaire-9(Baseline, Week 16, 6-month follow-up)
- Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)(Baseline, Week 16, 6-month follow-up)
- Number of participants with Bariatric surgery completion(6-month follow-up)
研究者
Caitlin Smith
Assistant Professor-Faculty
Medical University of South Carolina