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临床试验/NCT02441023
NCT02441023已完成不适用

Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial

Coordinación de Investigación en Salud, Mexico1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2013年3月1日最近更新:
适应症

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

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

发起方
Coordinación de Investigación en Salud, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lubia Velázquez López

M.Cs

Coordinación de Investigación en Salud, Mexico

研究点 (1)

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