Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main aim of this study is to evaluate the feasibility and effectiveness of a program for modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors in adults with different categories of risk from the primary health care strategy.
The project will show the effect of these interventions for the first time in people With different risk of developing type 2 diabetes throughout the life in populations living in Colombia Located in 2 different cities, one of them in the interior of the country (districts of Bogota) and another in the north coast (districts of Barranquilla) .
Cardiovascular disease (CVD) and type 2 diabetes (T2D) are currently the public health problems fastest growing globally. According to the International Diabetes Federation (IDF) is estimated to have diabetes approximately 382 million people in the world. It is shown that early interventions in lifestyle can reduce the burden of type 2 diabetes and factors of cardiovascular modifiable risk.
This is an intervention study in cluster. 36-month integrated into 4 phases:
For population screening test FINDRISC validated for the Latin American population will be employed and a score of 12 will be considered as a cutoff to all who have a score equal to or greater than 12 (moderate or high risk) they perform a test oral glucose tolerance (OGTT) according to the results 3 groups will be established
Intervention program: One year of duration, 3 types of programs are established.
An evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention_ structured | Experimental | One year Structured intervention program for members of high-risk group (People with glucose intolerance in the OGTT and FINDRISC score ≥12 points) 10 educational group sessions where they will receive information to change lifestyle (1 per 1.5 month) |
|
| Intervention_ Informative | Experimental | Program information intervention for the group with moderate risk. One year Informative intervention program (People with normotolerant or impaired fasting glucose in the OGTT and FINDRISC score ≥12 points). There is a single group session where they receive information to prevent cardiomatabolic risk factors |
|
| Intervention_ Communitarian | Experimental | One year, Intervention program at Community level. People with a FINDRISC less than 12 points. Campaigns are carried out at the community level with different strategies (leaflets, booklets) to prevent cardiomatabolic risk factors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention_ S | Behavioral | One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT)) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of body weight average at year-end structured intervention compared with the baseline. | Reduction of body weight in kilograms | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline. | Reduction of fasting glucose level in mg/dl | 12 Months |
| Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tania Acosta | Contact | 00573106331321 | tacosta@uninorte.edu.co | |
| Pablo Aschner | Contact | 00573106331321 | pabloaschner@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tania Acosta, MD, MPH | Universidad del Norte | Principal Investigator |
| Pablo Achner, MD, ENDOCRINOLOGIST | ASOCIACIÓN COLOMBIANA DE DIABETES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Del Norte | Recruiting | Barranquilla | Colombia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intervention_ I | Behavioral | One year Informative intervention program for members of moderate risk group (People with normotolerant or impaired fasting glucose in the OGTT and a FINDRISC score ≥12 points) |
|
|
| Intervention_ C | Behavioral | One year, Intervention program at Community level. People with a FINDRISC less than 12 points |
|
|
Reduction of 2-hour glucose level in mg/dl |
| 12 Months |
| Reduced of waist circumference average at year-end structured intervention program compared with baseline. | Reduction of waist circumference in centimeters | 12 Months |
| Asociación Colombiana de Diabetes | Recruiting | Bogotá | Colombia |
|
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided