Intervention Study for Smoking Cessation in Spanish College Students: Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Smoking cessation
研究概览
简要总结
This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.
详细描述
This study hipotetize that a multicomponent intervention, tailored to college student and conducted by a nurse is more effective than brief advise.
The intervention was a multi-component intervention based on the Theory of Triadic Influence and on previous recommendations made in the Surgeon General's report . The strategies of this program consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.
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 (Participant)
盲法说明
Randomization was performed by one member of the research team who generated a blocked random number sequence, using EpiInfo version 7.0.9.7, and prepared the sealed opaque sequentially numbered envelopes (1-255) with the corresponding condition written inside. After each student agreed to participate in the study, the enve- lope was opened, determining the group to which he or she would be assigned. Students were unaware of the group assignments and randomization scheme.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months
排除标准
- •Students who are ex-smokers
研究组 & 干预措施
Multicomponent intervention
The intervention group consisted in face-to-face 50-minute meeting [motivational interviewing (MI)]; online self-help material focused on: (1) decisions; (2) moods; (3) social life; (4) smoking health effects; and (5) quitting; e-mail 15 days before the MI, group therapy 2 months after the MI (60 minutes), a second follow-up visit 4 months after the MI (20 minutes).
干预措施: Multicomponent intervention (Behavioral)
Brief advice
The control group received a brief advice (5-10minutes) and a self-help pamphlet called 'Stop smoking'. Before giving brief advice, the nurse assessed smokers' habits and their willingness to quit. As is usually in this type of studies there were no follow-up sessions for this group.
干预措施: Brief advice (Behavioral)
结局指标
主要结局
Smoking cessation
时间窗: 6 month follow-up
The difference in the proportion of students who stopped smoking, between intervention and control subjects.
次要结局
- Smoking-related beliefs(6 month follow-up)
- Mean of smoked cigaretes(6 month follow-up)
- Stages of change according to Prochaska's model(6 month follow-up)
- Intention to quit smoking(6 month follow-up)
- Quit attempts(6 month follow-up)
- The self-efficacy to avoid smoking, and(6 month follow-up)