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
NCT ID: NCT03049839
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
650 participants
INTERVENTIONAL
2017-08-01
2019-12-30
Brief Summary
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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) .
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention_ structured
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_ S
One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))
Intervention_ Informative
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_ 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_ Communitarian
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
Intervention_ C
One year, Intervention program at Community level. People with a FINDRISC less than 12 points
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Wishing to participate and sign informed consent
Exclusion Criteria
* History of diseases or events that prevent their participation
* Neurological disability that does not allow you to make own decisions
* Pregnant women
30 Years
80 Years
ALL
Yes
Sponsors
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Universidad del Norte
OTHER
Responsible Party
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Principal Investigators
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Tania Acosta, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Universidad del Norte
Pablo Achner, MD, ENDOCRINOLOGIST
Role: PRINCIPAL_INVESTIGATOR
ASOCIACIÓN COLOMBIANA DE DIABETES
Locations
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Universidad Del Norte
Barranquilla, , Colombia
Asociación Colombiana de Diabetes
Bogotá, , Colombia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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55657
Identifier Type: -
Identifier Source: org_study_id
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