Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
1 other identifier
interventional
306
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Mar 2013
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 9, 2016
May 1, 2015
1.8 years
May 6, 2015
February 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic control
metabolic control which is evaluated by measuring the change in glycosylated hemoglobin
21 months
Secondary Outcomes (2)
Lipids profile
21 months
Body mass index (BMI)
21 months
Study Arms (2)
Nutritional therapy and education
EXPERIMENTAL1. 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.
Nutritional Therapy
NO INTERVENTIONNutritional 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes, following ADA \& WHO criteria
- Without severe marco or microvascular complications of diabetes
- HbA1c \> 6.5% and \<13.0%
You may not qualify if:
- Inability to or unwillnigness to access the multimedia or to follow dietary recommendations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS
Mexico City, Mexico City, 03100, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lubia Velazquez, M. Sc.,
Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.Cs
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 12, 2015
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
February 9, 2016
Record last verified: 2015-05
Data Sharing
- IPD Sharing
- Will share
Provide nutritional and educational measures in long-term in diabetes care.