Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Metabolic control
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.
详细描述
Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units (primary care), with HbA1c >6.5% and <13.0%, without advanced macro or microvascular complications of diabetes.
Two arms: the experimental group with nutrition therapy plus education in diabetes through a multimedia application. The application had seven modules: Introduction, nutrition, physical exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing diabetes, complications of diabetes. The control group received only usual nutrition therapy.
A monthly follow up during the first 7 months and then bimonthly, until 21 months of total follow up, with reinforcement in each visit of nutrition and other non-pharmacological therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided to both the patient and his family physician, so modification in drug treatment if needed, were performed.
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
- 30 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes, following ADA & WHO criteria
- •Without severe marco or microvascular complications of diabetes
- •HbA1c > 6.5% and <13.0%
排除标准
- •Inability to or unwillnigness to access the multimedia or to follow dietary recommendations
结局指标
主要结局
Metabolic control
时间窗: 21 months
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
次要结局
- Body mass index (BMI)(21 months)
- Lipids profile(21 months)
研究者
Lubia Velázquez López
M.Cs
Coordinación de Investigación en Salud, Mexico
