NCT03049839

Evaluation of a Community Health Program for the Prevention of Type 2 Diabetes and Other Cardio-metabolic Risk Factors in Adults: Districts of Barranquilla and Bogota, Colombia - January 2017 - December 2019

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Universidad del Norte · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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) .

Detailed description

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: 1. Design and adaptation of educational intervention 2. Population Screening 3. Stepwise intervention program 4. Evaluation results. 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 * High risk group: Subjects with FINDRISC score ≥12 and impaired glucose tolerance (IGT) * Moderate risk group: Subjects with FINDRISC score ≥12 and impaired fasting glucose or norm tolerant * Low risk group: Subjects with FINDRISC score \<12. Intervention program: One year of duration, 3 types of programs are established. * Lifestyle Intervention program\_ Communitarian: Intervention program at Community level with Low risk group. * Lifestyle Intervention program\_ Informative: Program information intervention for the group with moderate risk. * Lifestyle Intervention program\_ structured: intervention program for members of high-risk group. An evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.

Conditions

• Prediabetic State

Interventions

Type	Name	Description
BEHAVIORAL	Intervention_ S	One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))
BEHAVIORAL	Intervention_ I	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)
BEHAVIORAL	Intervention_ C	One year, Intervention program at Community level. People with a FINDRISC less than 12 points

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-10-30
• Completion: 2019-12-30
• First posted: 2017-02-10
• Last updated: 2019-03-12

Locations

2 sites across 1 country: Colombia