Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetic State
Lead sponsor: Universidad del Norte
Sponsor class: OTHER
First posted: 2017-02-10
Enrollment: 650
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of body weight average at year-end structured intervention compared with the baseline.
timeFrame: 12 Months
Secondary outcomes:
measure: Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.
timeFrame: 12 Months
measure: Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.
timeFrame: 12 Months
measure: Reduced of waist circumference average at year-end structured intervention program compared with baseline.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Universidad Del Norte
city: Bogota
country: Colombia
facility: Asociación Colombiana de Diabetes
Study officials:
affiliation: Universidad del Norte
name: Tania Acosta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: ASOCIACIÓN COLOMBIANA DE DIABETES
name: Pablo Achner, MD, ENDOCRINOLOGIST
role: PRINCIPAL_INVESTIGATOR
References: