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Clinical Trials/NCT02441023
NCT02441023
Completed
Not Applicable

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 site in 1 country306 target enrollmentMarch 2013
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Coordinación de Investigación en Salud, Mexico
Enrollment
306
Locations
1
Primary Endpoint
Metabolic control
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Coordinación de Investigación en Salud, Mexico
Responsible Party
Principal Investigator
Principal Investigator

Lubia Velázquez López

M.Cs

Coordinación de Investigación en Salud, Mexico

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Metabolic control

Time Frame: 21 months

metabolic control which is evaluated by measuring the change in glycosylated hemoglobin

Secondary Outcomes

  • Body mass index (BMI)(21 months)
  • Lipids profile(21 months)

Study Sites (1)

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