Type 2 Diabetes
Conditions
Keywords
type 2 diabetes mellitus, nutritional therapy, health education, self-management, multimedia
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.
Interventions
BEHAVIORALNutritional 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.
BEHAVIORALNutritional 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.
Sponsors
National Council of Science and Technology, Mexico
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic control | 21 months | metabolic control which is evaluated by measuring the change in glycosylated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipids profile | 21 months | Lipid profile includes the evaluation of total cholesterol, triglycerides, HDL-c and LDL-c |
| Body mass index (BMI) | 21 months | It is evaluated by measuring the weight in relation to height |
Countries
Mexico
Outcome results
None listed