Assessing the Efficacy and Impact of a Personalized Smoking Cessation Intervention Among Type 2 Diabetic Smokers in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Continuous smoking abstinence
研究概览
简要总结
People with diabetes still smoke at equivalent rates as non-diabetics. There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes. The aim of this project is to assess the 12 months efficacy of a smoking cessation intervention tailored to diabetes and gender specificities, in a population of 500 smokers with type 2 diabetes. The secondary objectives are to assess the impact of smoking cessation on anthropometric outcomes, diabetes control and renal function and fecal microbiota.
详细描述
Smoking and diabetes are both major public health burden. They act synergistically on morbidity and mortality. Micro and macro-vascular complications are dramatically increased among diabetic smokers; however people with diabetes still smoke at equivalent rates as non-diabetics. There is lack of evidence regarding interventions for smoking cessation among individuals with diabetes and the small number of existent studies has yielded mixed results.
The aim of this project is to assess the 52 weeks (12 months) efficacy of a smoking cessation intervention tailored to diabetes and gender specificities, in a population of smokers with type 2 diabetes.
The secondary objectives are to assess the impact of smoking cessation on anthropometric outcomes, diabetes control and renal function.
The exploratory objectives are to assess the impact of smoking cessation on fecal microbiota The nested sub-study's exploratory objectives are to explore the associations between social stigma and diabetes, and mental health and diabetes.
The study design is an open label, randomized controlled trial with a nested cross-sectional study.
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
- Double (Participant, Outcomes Assessor)
盲法说明
According to the article 18 of the LRH, participants will not be given the full information regarding the main purpose of the study (assess the efficacy of a smoking cessation trial) in order not to influence participants regarding the intervention and also to decrease selection bias (only smokers motivated to quit would take part and thus induce a selection bias). Methodologically, such a blinding to procedure would allow a better assessment of its efficacy. Furthermore, risks associated to the intervention are considered as very low. Participants will be informed a posteriori once they have completed the study or before in case they remove their consent or quit the study.
The outcome assessor will be a research collaborator independent of the study nurse who performed the intervention and blinded to the intervention.
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
- •Informed Consent as documented by signature;
- •Having smoked > 100 cigarettes during his/her entire life and currently smoking cigarettes (no minimal threshold);
- •Having been diagnosed with a type 2 diabetes;
- •Being ≥ 18 years old;
- •Speaking and understanding French
排除标准
- •Not being able to give an informed consent and follow the procedure of the study (due to dementia, psychological disorder, language problem);
- •Being pregnant or breastfeeding;
- •Being enrolled in another smoking cessation study or program or in a multi-behavioral program including smoking cessation;
- •Enrolment of the investigator or other research collaborators, their family members, employees and other dependent persons;
- •Planning to move out of Switzerland within the next year.
结局指标
主要结局
Continuous smoking abstinence
时间窗: Measured at 52 weeks
continuous abstinence rate from week 12 (end of intervention) to week 52 (end of follow-up), defined as self-report of no smoking or use of other nicotine containing products (ENDS, smokeless tobacco) since the previous visit or contact, confirmed by expired monoxide level \< 10 ppm.
次要结局
- Renal function(Change is measured from baseline to 26 weeks.)
- Point prevalence smoking abstinence(Change is measured at 52 weeks)
- Motivation to quit smoking(Change is measured from baseline to 52 week)
- Harm reduction(Change is measured at 52 week)
- Weight change(Change from baseline to 52 week)
- Metabolic control(Change is measured from baseline to 52 week)
- Number of smoking quit attemps(Change is measured from baseline to 12 week)
- Continuous smoking abstinence(At week 26)
- Number of smoking quit attempts(Change is measured from baseline to 52 week.)
- Change in waist circumference(Change from baseline to 52 week.)
研究者
Carole Clair
Principal Investigator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland