Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Adherence to the Mediterranean diet
研究概览
简要总结
This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group. Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.
排除标准
- •Personal history of atherosclerotic disease.
- •Unable to do exercise or follow the Mediterranean diet.
- •Institutionalized.
- •Terminal illness.
- •Mental disorders that limited the intervention compliance.
结局指标
主要结局
Adherence to the Mediterranean diet
时间窗: 1 year
Measurement by validated 14-point Mediterranean Diet Adherence Screener
Self-reported physical activity
时间窗: 1 year
Measurement by short version of the International Physical Activity Questionnaire
次要结局
- Changes in physical activity(1 year)
- Immediate verbal memory(1 year)
- Executive functions(1 year)
- Changes in dietary pattern(1 year)
- Body composition(1 year)
- Attention(1 year)
- Processing speed(1 year)
- Working memory(1 year)
- Cardiovascular risk factors(1 year)
- Brachial-ankle pulse wave velocity (ba-PWV)(1 year)
- Delayed verbal memory(1 year)
- Selective attention(1 year)
- Ankle-brachial index (ABI)(1 year)
- Health related quality of life(1 year)
- Phonological fluency(1 year)
- Cardio-ankle vascular index (CAVI)(1 year)
- Sustained attention(1 year)