Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,292
- 试验地点
- 1
- 主要终点
- Self-reported 30-day Point Prevalence Abstinence
研究概览
简要总结
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.
详细描述
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT.
Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT.
Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments.
Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Current smoker
- •Registered user on BecomeAnEX.org
排除标准
- •Pregnant or breastfeeding
- •Cardiovascular conditions
- •Current use of any stop smoking medication
研究组 & 干预措施
WEB only
Control group receiving no additional intervention
干预措施: WEB (Behavioral)
WEB+SN
WEB plus social network intervention.
干预措施: WEB (Behavioral)
WEB+SN
WEB plus social network intervention.
干预措施: Social Network (Behavioral)
WEB+NRT
WEB plus nicotine replacement therapy product.
干预措施: WEB (Behavioral)
WEB+SN+NRT
WEB plus social network intervention and nicotine replacement therapy product.
干预措施: WEB (Behavioral)
WEB+SN+NRT
WEB plus social network intervention and nicotine replacement therapy product.
干预措施: Social Network (Behavioral)
WEB+SN+NRT
WEB plus social network intervention and nicotine replacement therapy product.
干预措施: Nicotine Replacement Therapy (NRT) (Behavioral)
WEB+NRT
WEB plus nicotine replacement therapy product.
干预措施: Nicotine Replacement Therapy (NRT) (Behavioral)
结局指标
主要结局
Self-reported 30-day Point Prevalence Abstinence
时间窗: 9 months post-randomization
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.
次要结局
- Self-reported 30-day Point Prevalence Abstinence(3 months post-randomization)
研究者
Amanda L. Graham, PhD
Director, Research Development
Truth Initiative
