Partnering With a State Food Bank to Provide Tobacco Treatment to Underserved Smokers (Project NOURISH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Self Reported 7 Day Abstinence Smoking Status
研究概览
简要总结
This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥100 lifetime cigarettes
- •English or Spanish speaking
- •Currently smoke ≥5 cigarettes/day
- •Process a smartphone compatible with the project app
- •Have a valid email address
- •Receipt of food assistance in the past 3 month
排除标准
- •Currently pregnant or breastfeeding
- •Current use of smoking cessation medications
- •Enrolled in a smoking cessation study
- •Household member enrolled in the study
- •Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone
研究组 & 干预措施
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
干预措施: Counseling (Behavioral)
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
干预措施: Nicotine patch (Drug)
Standard Treatment
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
干预措施: Nicotine lozenge (Drug)
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content that is tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Nicotine lozenge (Drug)
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content that is tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Smartphone-delivered automated treatment (Behavioral)
Automated Treatment
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and negative affect/stress; 2) 26 weeks of on-demand access to treatment content that is tailored on smoking status, motivation, agency, and negative affect/stress; 3) 26 weeks of text content.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Self Reported 7 Day Abstinence Smoking Status
时间窗: 12 Month Follow-Up
Participants will self report 7-day abstinence smoking status
Self-Reported 7-Day Point-Prevalence Smoking Abstinence
时间窗: 12 Month Follow-Up
Participants who report no smoking, not even a puff, within the past 7 days
次要结局
- 30 Day Smoking Abstinence(12 Month Follow-Up)
- Smoking Status by Saliva Cotinine Kit(12 Month Follow-Up)
- Self Reported 24 Hours Smoking Abstinence(12 Month Follow-Up)
- Continuous Smoking Abstinence(12 Month Follow-Up)
- Biochemical Verification Via Salivary Cotinine(12 Month Follow-Up)
- Self-Reported 24-Hour Point-Prevalence Smoking Abstinence(12 Month Follow-Up)
- Self-Reported 30-Day Point-Prevalence Smoking Abstinence(12 Month Follow-Up)