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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Nutritional therapy and education
Nutritional therapy
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes mellitus, nutritional therapy, health education, self-management, multimedia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nutritional therapy and education

Nutritional Therapy

Arm Description

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. 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2015
Last Updated
February 6, 2016
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
National Council of Science and Technology, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02441023
Brief Title
Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
Official Title
Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
National Council of Science and Technology, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes mellitus, nutritional therapy, health education, self-management, multimedia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional therapy and education
Arm Type
Experimental
Arm Description
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. 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.
Arm Title
Nutritional Therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional therapy and education
Intervention Description
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. 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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Metabolic control
Description
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
Time Frame
21 months
Secondary Outcome Measure Information:
Title
Lipids profile
Description
Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c
Time Frame
21 months
Title
Body mass index (BMI)
Description
It is evaluated by measuring the weight in relation to height
Time Frame
21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lubia Velazquez, M. Sc.,
Organizational Affiliation
Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Provide nutritional and educational measures in long-term in diabetes care.

Learn more about this trial

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

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