NCT03579420Unknown不适用
Efficacy of a Brief Group Program Versus a Longer Structured Program for Therapeutic Education of Patients With Type 2 Diabetes.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Treatment success at 6 months
研究概览
简要总结
The study will compare two different programs for lifestyle intervention in type 2 diabetes:
- A brief group program, with three weekly sessions
- A longer group program, with six weekly sessions, which has been routinely used for the management of type 2 diabetic patients in this hospital for several years.
The aim is that of demonstrating the non-inferiority of the new brief, and more sustainable, program, in comparison with the more traditional approach.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c between 48 and 75 mmol/mol
排除标准
- •Axis I Mental Disorders
- •Heart failure (NYHA Class III or IV)
- •Foot ulcers or lower limb amputations
结局指标
主要结局
Treatment success at 6 months
时间窗: 6 months
HbA1c within predefined target without any increase in pharmacological therapy
HbA1c at 6 months
时间窗: 6 months
次要结局
- Treatment success at 24 months(24 months)
- Well-being Enquiry in Diabetics (WED) questionnaire total score(24 months)
- Waist circumference(24 months)
- International Physical Activity Questionnaire-Short Form (IPAQ-SF) scores(24 months)
- Body Mass Index(24 months)
- HbA1c at 24 months(24 months)
- MEditerranean DIet adherence LITErature-based (MEDI-LITE) questionnaire scores(24 months)
研究者
Edoardo Mannucci
Director, Diabetology
Azienda Ospedaliero-Universitaria Careggi
研究点 (2)
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