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

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ClinicalTrials.gov Identifier: NCT02441023
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : February 9, 2016
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Nutritional therapy and education Behavioral: Nutritional therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Metabolic control [ Time Frame: 21 months ]
    metabolic control which is evaluated by measuring the change in glycosylated hemoglobin


Secondary Outcome Measures :
  1. Lipids profile [ Time Frame: 21 months ]
    Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c

  2. Body mass index (BMI) [ Time Frame: 21 months ]
    It is evaluated by measuring the weight in relation to height



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441023


Locations
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Mexico
Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS
Mexico, Distrito Federal, Mexico, 03100
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
National Council of Science and Technology, Mexico
Investigators
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Principal Investigator: Lubia Velazquez, M. Sc., Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS

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Responsible Party: Lubia Velázquez López, M.Cs, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02441023     History of Changes
Other Study ID Numbers: 2012-C01-181015
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Provide nutritional and educational measures in long-term in diabetes care.
Keywords provided by Lubia Velázquez López, Coordinación de Investigación en Salud, Mexico:
type 2 diabetes mellitus
nutritional therapy
health education
self-management
multimedia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs