Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02441023|
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Nutritional therapy and education Behavioral: Nutritional therapy||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Nutritional therapy and education
Behavioral: Nutritional therapy and education
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.
- Metabolic control [ Time Frame: 21 months ]metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
- Lipids profile [ Time Frame: 21 months ]Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c
- Body mass index (BMI) [ Time Frame: 21 months ]It is evaluated by measuring the weight in relation to height
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
|Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS|
|Mexico, Distrito Federal, Mexico, 03100|
|Principal Investigator:||Lubia Velazquez, M. Sc.,||Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS|