Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in Body Weight
研究概览
简要总结
The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). The study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). Anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obesity (BMI ≥25 kg/m2)
- •Participants with or at risk of Type 2 Diabetes Mellitus
- •Skills in the use web-based technologies and internet accessibility
排除标准
- •Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.
结局指标
主要结局
Change from baseline in Body Weight
时间窗: Baseline, month 3, month 6, month 9 and month12
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
次要结局
- Change from baseline in body circumferences(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in Quality of life by 36-item short form health survey (SF-36)(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in BMI(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in HbA1C(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in Systolic and Diastolic blood pressure(Baseline, month 3, month 6, month 9 and month12)
- Change from baseline in fasting blood glucose(Baseline, month 3, month 6, month 9 and month12)
研究者
Ester Vitacolonna
Professor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara