Harm Reduction in Smokers With Obesity: Impact of Contingent Incentives and E-Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Within-Treatment Smoking Abstinence
研究概览
简要总结
The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on smoking in individuals with overweight/obesity who smoke cigarettes (SWO). All participants will be provided information on the comparative risk of ENDS relative to cigarette smoking, and a randomized group of participants will be provided ENDS provisions for 6 weeks. All participants will complete breath samples for 28 days to measure their exhaled carbon monoxide and will either receive fixed incentives for sample completion or receive varying incentives contingent on their carbon monoxide levels. Researchers will compare groups to understand the effect of each condition on smoking-related behavior.
详细描述
Individuals with overweight/obesity who smoke cigarettes (SWO) have greatly increased risks of metabolic, cardiac, and pulmonary diseases due to the synergistic effects of tobacco and obesity. Switching to electronic nicotine delivery systems (ENDS) may decrease the risk of negative health outcomes and be a promising approach for SWO. The purpose of this study is to provide preliminary information on the effect of electronic nicotine delivery systems (ENDS) provisions and contingent incentives (CI) on individuals with overweight/obesity who smoke cigarettes (SWO). The primary aim of this study is to examine the effect of ENDS provision on smoking and the effect of the provision of CI provision on smoking. The secondary aims are to assess the effects of ENDS and CI provision on exhaled carbon monoxide (CO), cigarette dependence, intention to quit smoking, and quitting self-efficacy, and to determine whether any changes in weight occurred secondary to the use of ENDS. Evidence of the efficacy of switching to ENDS and the use of CI could be utilized in healthcare settings to reduce the risk of morbidity and mortality among smokers with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will not know the outcome of randomized assignment.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 25 kg/m2
- •smoked ≥ 5 cigarettes/day during the past year
- •21 or older
- •exhaled CO of > 6 ppm at Baseline
- •willing to use ENDs for 6 weeks
- •daily access to a Bluetooth-enabled smartphone/tablet
排除标准
- •planning to set a smoking quit date in the next 30 days
- •receiving smoking cessation treatment of any kind in the past 30 days
- •currently using ENDS > 4 day per month
- •hospitalized for mental illness in past 30 days
- •heart-related event (e.g., heart attack, severe angina) in past 30 days
- •resides with another person enrolled in the study
- •pregnant, nursing, or planning to become pregnant in the next 6 months.
结局指标
主要结局
Within-Treatment Smoking Abstinence
时间窗: Daily for 4 weeks
Number of days during the incentive period with CO verified abstinence from smoking
Use of Cigarettes and ENDS
时间窗: Assessed 4, 6, and 12 weeks follow-up
Daily use of cigarettes and ENDS will be determined using the Timeline Follow-Back (TLFB) in follow-up assessments post-treatment.
次要结局
- Comparing E-Cigarettes and Cigarettes Questionnaire(Assessed 4, 6, and 12 weeks follow-up)
- Carbon monoxide (CO)(Assessed 4, 6, and 12 weeks follow-up)
- Motivation to change(Assessed 4, 6, and 12 weeks follow-up)
- Cigarette and E-Cigarette Dependence(Assessed 4, 6, and 12 weeks follow-up)
- Weight(Assessed 4, 6, and 12 weeks follow-up)