Community based group intervention for tobacco cessation in rural Tamilnadu: A Cluster randomized trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Self reported point prevalence abstinence (No tobacco use in the past 7 days).
研究概览
简要总结
Tobacco use is the leading most preventable cause of death. More than 70% of tobacco users in India live in rural areas. So there is an urgent need to develop evidence based interventions for tobacco cessation. This study is cluster randomized trial comparing the efficacy of group intervention and self help materials for tobacco cessation in 400 eligible participants recruited from 20 villages in Manaparai taluk, Thiruchirappalli, Tamilnadu. The primary outcome measure will be self reported point prevalence abstinence (No tobacco use in the past 7 days). The secondary outcomes will be any attempt to quit tobacco which last more than 24 hours and reduced tobacco consumption to more than 50% of initial use at two months after intervention.
研究设计
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
入选标准
- •Adult men between 20-40 years of age2) Resident of the village3) Current user of any forms of tobacco.
排除标准
- •Women tobacco users2)Bedridden patients with debilitating illness3)Individuals planning for migration in the next three months4)Mentally challenged.
结局指标
主要结局
Self reported point prevalence abstinence (No tobacco use in the past 7 days).
时间窗: Two months after recieving the intervention
次要结局
- Any attempt to quit tobacco which last more than 24 hours. Reduced tobacco consumption to more than 50% of initial use.(Two months)