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临床试验/NCT02220465
NCT02220465Unknown1 期

Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking

Temple University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
90
试验地点
1
主要终点
Smoking Cue Reactivity on Quit Day

研究概览

简要总结

The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.

详细描述

Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing to disproportionate rates of morbidity/mortality (MM) among low income underserved adults. Comprehensive interventions incorporating treatment of multiple risk behaviors can have immense public health impact. The goal of this study is to improve uptake of PA during the pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible participants (sedentary, >5 cigs/day) will be randomized to 8-week LMPA vs. standard of care (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b) integrates PA with evidence-based smoking cessation programming by explicitly linking short bouts of PA with urge management training during the pre-quit period. The SCC group receives standard care smoking cessation counseling. Group differences in quit day reduction (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking quit rates at 1-week and 1-month follow-up will be examined.

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 59 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •intent-to-treat sedentary male and female smokers (intention to quit within the next 6 months) - - - smoke 6 or more cigarettes per day.
  • •Sedentary critieria: not purposeful physical activity for less than 20 minutes of vigorous intensity, or less than 60 minutes of moderate intensity physical activity per week, or less than 100 minutes of time spent walking per week.

排除标准

  • •pregnancy
  • •current substance abuse (e.g., alcohol, cocaine, or stimulants);
  • •current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol, Thorazine).

研究组 & 干预措施

PA+ Smoking Cessation (LMPA)

Experimental

This intervention integrates low-to-moderate physical activity (PA) with evidence based smoking cessation programming. Over the 4-week treatment period, the intervention (1 in-person and 3 phone counseling sessions) focuses on (a) gradually increasing routine PA during the pre-quit period and maintaining PA post quit day (b) increasing daily PA (steps/day) using a weekly tailored algorithm with the goal of achieving 10,000 steps by Week 4 (quit day) and (c) training participants to use PA as a primary urge management strategy, thereby embedding PA within evidence-based smoking cessation counseling. Other components include additional smoking urge management skills, increasing motivation to quit, overcoming barriers and maintaining PA for quitting and staying smoke-free .

干预措施: PA+ Smoking Cessation (LMPA) (Behavioral)

Standard Care Smoking Counseling (SCC)

Active Comparator

The control intervention parallels the format of the LMPA intervention with focus only on behavioral and cognitive urge management strategies (avoiding/escaping high-risk situations, stimulus control) and minimizing the probability that participants in the control group would increase increase/use PA during the intervention period. Participants are provided a pedometer without any instructions or encouragement around increasing walking/steps during the 8-week intervention period.

干预措施: Standard Care Smoking Counseling (SCC) (Behavioral)

结局指标

主要结局

Smoking Cue Reactivity on Quit Day

时间窗: 4-weeks

smoking cue reactivity is a behavioral predictor of smoking outcomes. We anticipate that the LMPA intervention will experience greater reductions (extinction) during a controlled, massed cue exposure procedure on their quit day than the Standard care control (SCC) group.

次要结局

  • Quit rates at follow ups(7 days prior to 1week and 1 month follow up assessments)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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