Evaluation of a Teaching and Treatment Programme for Primary Prevention of Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Weight Change
研究概览
简要总结
A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors
详细描述
The PREDIAS programme was developed based on the interventions used in the Diabetes Prevention Study (DPS, Finland) and the Diabetes Prevention Programme (DPP; USA). The main purpose of PREDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •impaired fasting glucose and/or
- •impaired glucose tolerance
- •overweight (BMI > 26 kg/m²)
排除标准
- •type 2 diabetes
- •severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
- •diagnosis of a current mental disease
研究组 & 干预措施
1/Control
Control group received written information about diabetes risks with instructions about healthy eating and increasing physical exercise
干预措施: Control (Behavioral)
2/PREDIAS
Intervention consists of a group programme (PREDIAS) aiming at modification of lifestyle
干预措施: PREDIAS (Behavioral)
结局指标
主要结局
Weight Change
时间窗: 12 month
Mean weight change (in kg) after 12 months
Waist Circumference
时间窗: 12 months
Mean change in waist circumference (in cm) after 12 months
次要结局
- Physical Exercise(12 months)
- Eating Behavior (TFEQ) - Cognitive Restraint(12 months)
- Eating Behavior (TFEQ) - Hunger(12 months)
- Emotional Well-being/ Depression (CES-D)(12 months)
- Fasting Glucose(12 months)
- Glucose Tolerance(12 months)
- Eating Behavior (TFEQ) - Disinhibition(12 months)
- Psychological Well-being (WHO-5)(12 months)
研究者
Norbert Hermanns
PhD
Forschungsinstitut der Diabetes Akademie Mergentheim