Mobile Health Intervention to Help Low-Income Smokers Quit Smoking and Increase Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants Who Self-report Prolonged Abstinence From Smoking
研究概览
简要总结
This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).
详细描述
This pilot project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and physical activity among low-income persons. The intervention, named Smoking Treatment and Exercise Program for Underserved Populations (STEP UP), combines a smartphone-based contingency-management application (app), which provides monetary reinforcement for smoking abstinence and physical activity, 5 weeks of telephone-based cognitive-behavioral therapy (CBT) to prevent relapse, nicotine replacement pharmacotherapy, and text-messaging to support physical-activity goals. Participants are given a smartphone, a compact carbon-monoxide (CO) monitor, with which recency of smoking can by determined, and a Garmin Vivosmart wristband step-tracker. Twice a day at semi-random intervals, participants are prompted by the app to submit a video of themselves blowing into the CO monitor. Monetary reinforcement is then immediately provided contingent upon a below-threshold CO reading. The app also continuously syncs with the Garmin step-tracker, providing supportive messaging and bonus incentives-namely doubled reinforcement for smoking abstinence among participants who meet personalized daily step goals. The expected outcome of the project is to provide information to evaluate the efficacy of an innovative approach in preparation for a subsequent larger clinical trial that builds upon the capabilities of mHealth technology to reduce the prevalence of smoking among low income smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current household income less than twice the federal poverty guidelines (Finer & Henshaw, 2006; for instance, someone from a family of 4 must have a household income less than $48,500 to be eligible)
- •currently smoke >10 cigarettes a day
- •smoking for at least the past year
- •can speak and write fluent conversational English
- •are 18-70 years of age
- •are willing to make an attempt to quit smoking and increase physical activity
排除标准
- •inability to walk
- •expected to have unstable medication regimen during the study
- •currently receiving non-study behavioral treatment for smoking
- •myocardial infarction in the past 6 months
- •contraindication to nicotine replacement therapy (NRT) or bupropion with no medical clearance
- •exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing tobacco
- •current pregnancy
- •current imprisonment or psychiatric hospitalization
研究组 & 干预措施
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Cognitive Behavioral Counseling (Behavioral)
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Mobile Contingency Management (Behavioral)
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Bupropion (Drug)
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Transdermal nicotine patch (Drug)
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Nicotine polacrilex (Drug)
STEP UP
STEP UP is an intervention that combines evidence-based telephone cognitive behavioral counseling for smoking cessation, access to nicotine replacement therapy (NRT; including transdermal nicotine patch and either nicotine polacrilex or nicotine lozenge) and bupropion, and intensive mobile contingency management behavioral therapy administered via a smart-phone based application.
干预措施: Nicotine lozenge (Drug)
结局指标
主要结局
Number of Participants Who Self-report Prolonged Abstinence From Smoking
时间窗: 3 month follow up
Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
Number of Participants Whose Prolonged Abstinence is Bio-verified
时间窗: 3 month follow up
Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.
次要结局
- Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking(6 month follow up)
- Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking(3 month follow up)
- Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking(3 month follow up)
- Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.(baseline and 3 month follow up)
- Change in the Number of Days in Which Smoked Compared to Pre-quit Use(3 month follow up)
- Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit(3 month follow up)
- Number of Quit Smoking Attempts(3 month follow up)