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

Prediabetic State Clinical Trial

— PREDICOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03049839
• Other study ID #: 55657
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2019
• Source: Universidad del Norte
• Contact: Tania Acosta
• Phone: 00573106331321
• Email: tacosta[@]uninorte.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• People over age 30 years, residents within the perimeter of the conglomerate in the districts of Barranquilla and Bogota

• Wishing to participate and sign informed consent

Exclusion Criteria:

• DT2 known and / or treated

• History of diseases or events that prevent their participation

• Neurological disability that does not allow you to make own decisions

• Pregnant women

Related Conditions & MeSH terms

• Prediabetic State

Intervention

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))
• 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)
• Intervention_ C
One year, Intervention program at Community level. People with a FINDRISC less than 12 points

Locations

Country	Name	City	State
Colombia	Universidad Del Norte	Barranquilla
Colombia	Asociación Colombiana de Diabetes	Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Norte

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of body weight average at year-end structured intervention compared with the baseline.	Reduction of body weight in kilograms	12 Months
Secondary	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
Secondary	Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.	Reduction of 2-hour glucose level in mg/dl	12 Months
Secondary	Reduced of waist circumference average at year-end structured intervention program compared with baseline.	Reduction of waist circumference in centimeters	12 Months