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Clinical Trial Summary

GOALS:

PRIMARY:

1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure).

SECONDARY:

2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height).

3. Analyze the impact of the program on the quality of life related to health.

4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

DESIGN: Cluster randomized controlled trial


Clinical Trial Description

The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03453970
Study type Interventional
Source University of Malaga
Contact
Status Active, not recruiting
Phase N/A
Start date December 1, 2018
Completion date December 1, 2021

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