Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes

February 6, 2016 updated by: Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 03100
        • Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of type 2 diabetes, following ADA & WHO criteria
  • Without severe marco or microvascular complications of diabetes
  • HbA1c > 6.5% and <13.0%

Exclusion criteria:

  • Inability to or unwillnigness to access the multimedia or to follow dietary recommendations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional therapy and education
  1. Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
  2. Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials.
Behavioral: Nutritional therapy and education
  1. Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
  2. Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials.
Behavioral: Nutritional therapy
Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association Standards for medical care in diabetes.
No Intervention: Nutritional Therapy
Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic control
Time Frame: 21 months
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipids profile
Time Frame: 21 months
Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c
21 months
Body mass index (BMI)
Time Frame: 21 months
It is evaluated by measuring the weight in relation to height
21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Collaborators

National Council of Science and Technology, Mexico

Investigators

  • Principal Investigator: Lubia Velazquez, M. Sc.,, Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 6, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-C01-181015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Provide nutritional and educational measures in long-term in diabetes care.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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