Effectiveness of a Multifactorial Intervention to Improve Diet and Physical Activity in Diabetic Patients From Primary Care: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener
研究概览
简要总结
This is a randomized, clinical trial aimed at diabetics between 25-70 years (with no cardiovascular disease) selected at urban primary care health clinics in Salamanca (Spain). It is aimed at assessing the effects of adding an ICT (information and communication technology) tool, developed for the Smartphone application and group activities of healthy food and cardio-health rides in support of behavioral and educational recommendations in the increased physical activity and adaption to the Mediterranean dietary pattern.
详细描述
Objective:
The main objective of this study is to evaluate the effect of adding a multifactorial intervention (ICT tool for Smartphone, cardio-health rides and a standardized advice about eating habits) to the usual care in the increase of the physical activity, in order to reach the international recommendations and in the Increased adherence to the Mediterranean diet in type 2 diabetic patients. Secondary objectives will be to evaluate the effect of intervention in improving dietary patterns, cardiovascular risk factors and metabolic control.
Design and setting:
A randomised controlled clinical trial, with two parallel groups, aimed at assessing the effects of adding an ICT tool and group activities on healthy food and cardio-health rides (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaption to the Mediterranean dietary pattern.
Study setting:
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Diabetes Mellitus Type 2 since 25 to 70 years.
排除标准
- •Older than 70 years are excluded, due to difficulties in the use of ICTs.
- •History of cardiovascular events (acute myocardial infarction, stroke, etc).
- •Diagnosis of clinically demonstrable neurological and/or neuropsychological disease.
- •Muscular-skeletal pathology that inhibit mobility.
- •Those with any other circumstance that the investigators consider could interfere with the study procedures.
研究组 & 干预措施
Control: Lifestyle counseling
Counseling on physical activity and Mediterranean diet.
干预措施: Control: Lifestyle counseling (Other)
Intervention group
Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.
干预措施: Intervention group (Other)
Intervention group
Add for three months a smartphone with an app (EVIDENT) to improve alimentation and physical activity, five cardio-health rides and feeding workshop.
干预措施: Control: Lifestyle counseling (Other)
结局指标
主要结局
Adherence to the Mediterranean diet using the validated 14-point Mediterranean Diet Adherence Screener
时间窗: 1 year
Principal endpoint of alimentation, will be measured using the validated 14-point Mediterranean Diet Adherence Screener.
Self-reported physical activity measured by the International Physical Activity Questionary - Short Form
时间窗: 1 year
Measured by the International Physical Activity Questionary - Short Form
次要结局
- Fasting Plasma Glucose(1 year)
- Cardiovascular risk factors measured by Framingham Risk Score(1 year)
- Increase physical activity measurement by pedometer(1 year)
- HbA1c(1 year)
- Quality of life measured by SF-12 test(1 year)