DIMINI - Activating of Health Literacy in Persons With an Increased Risk of Type 2 Diabetes Mellitus by Coaching at General Practitioners
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- Body weight reduction
研究概览
简要总结
The increasing prevalence of type 2 diabetes mellitus is a worldwide problem. In preventing risk factors and unhealthy lifestyle through improved health literacy, chances are seen to delay or even avoid type 2 diabetes mellitus. The aim of the DIMINI-project is to prevent type 2 diabetes mellitus and to strengthen the health literacy of people at increased risk of developing it. For this purpose, people at increased risk are first identified by using the standardized screening tool Finnish Diabetes Risk Score (FINDRISC) adapted for Germany. Identified risk persons then receive a needs-based, modular lifestyle intervention including nutrition tips and physical exercises either paper- or app-based.
详细描述
DIMINI, a randomised controlled trial, will assess whether the implementation of a lifestyle intervention for people at increased risk of developing type 2 diabetes mellitus will result in an improvement in body weight (primary outcome) and participants health literacy (secondary outcome) or not. A three-month intervention in the intervention group is followed by a one-year follow-up. The control group receives standard care as provided by the German statutory health insurance for three months and a one-year follow-up as well.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 years
- •resident in Hesse or Schleswig-Holstein
- •statutory health insurance in one out of five participating health insurances
- •overweight/obesity
- •low physical activity
- •known family disposition for type 2 diabetes mellitus
- •history of increased glucose levels
- •FINDRISC results with scores ≥ 12
排除标准
- •age < 18 years
- •resident outside Hesse or Schleswig-Holstein
- •statutory or private health insurance with other than the participating health insurances
- •clinically manifested diabetes mellitus
- •malnutrition
- •psychiatric disorders
- •pregnancy
- •FINDRISC results with scores <12
- •participation in other clinical trials
研究组 & 干预措施
Control Group
The control group will receive standard care as provided by the German statutory health insurance.
Intervention group
The intervention group receives the DIMINI lifestyle intervention for a period of three months.
干预措施: DIMINI lifestyle intervention (Behavioral)
结局指标
主要结局
Body weight reduction
时间窗: 15 Months
Survey of weight general practitioners level
次要结局
- Health literacy (European Health Literacy Survey Questionnaire)(15 Months)
- Quality of life(15 Months)
- Eating behaviour (German questionnaire on eating behaviour)(15 Months)
- Physical activity (International Physical Activity Questionnaire)(15 Months)