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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 (PREDICOL)

Primary Purpose

Prediabetic State

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Intervention_ S
Intervention_ I
Intervention_ C
Sponsored by
Universidad del Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Del NorteRecruiting
  • Asociación Colombiana de DiabetesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention_ structured

Intervention_ Informative

Intervention_ Communitarian

Arm Description

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)

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

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

Outcomes

Primary Outcome Measures

Reduction of body weight average at year-end structured intervention compared with the baseline.
Reduction of body weight in kilograms

Secondary Outcome Measures

Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.
Reduction of fasting glucose level in mg/dl
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
Reduced of waist circumference average at year-end structured intervention program compared with baseline.
Reduction of waist circumference in centimeters

Full Information

First Posted
October 21, 2016
Last Updated
March 8, 2019
Sponsor
Universidad del Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03049839
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad del Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Design and adaptation of educational intervention Population Screening Stepwise intervention program 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention_ structured
Arm Type
Experimental
Arm Description
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)
Arm Title
Intervention_ Informative
Arm Type
Experimental
Arm Description
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
Arm Title
Intervention_ Communitarian
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Intervention_ S
Other Intervention Name(s)
LIP_Structures
Intervention Description
One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))
Intervention Type
Behavioral
Intervention Name(s)
Intervention_ I
Other Intervention Name(s)
LIP_Informative
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Intervention_ C
Other Intervention Name(s)
LIP_Communitarian
Intervention Description
One year, Intervention program at Community level. People with a FINDRISC less than 12 points
Primary Outcome Measure Information:
Title
Reduction of body weight average at year-end structured intervention compared with the baseline.
Description
Reduction of body weight in kilograms
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.
Description
Reduction of fasting glucose level in mg/dl
Time Frame
12 Months
Title
Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.
Description
Reduction of 2-hour glucose level in mg/dl
Time Frame
12 Months
Title
Reduced of waist circumference average at year-end structured intervention program compared with baseline.
Description
Reduction of waist circumference in centimeters
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Acosta
Phone
00573106331321
Email
tacosta@uninorte.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Aschner
Phone
00573106331321
Email
pabloaschner@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Acosta, MD, MPH
Organizational Affiliation
Universidad del Norte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pablo Achner, MD, ENDOCRINOLOGIST
Organizational Affiliation
ASOCIACIÓN COLOMBIANA DE DIABETES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Del Norte
City
Barranquilla
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tania Acosta, MD, MPH, PhD
Phone
00573106331321
Email
tacosta@uninorte.edu.co
First Name & Middle Initial & Last Name & Degree
Tania Acosta, MD, MPH
First Name & Middle Initial & Last Name & Degree
Edgar Navarro, MD, MSC
First Name & Middle Initial & Last Name & Degree
Jorge Acosta, MD, MSC
First Name & Middle Initial & Last Name & Degree
Rafael Tuesca, MD, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Sandra Rodriguez, PhD
First Name & Middle Initial & Last Name & Degree
Jesus Arroyabe, PhD
First Name & Middle Initial & Last Name & Degree
Karen Florez, PhD
First Name & Middle Initial & Last Name & Degree
Sara Caro, MSC
First Name & Middle Initial & Last Name & Degree
Mariela Borda, MSC
Facility Name
Asociación Colombiana de Diabetes
City
Bogota
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Aschner, MD
Phone
00573102118652
Email
pabloaschner@gmail.com
First Name & Middle Initial & Last Name & Degree
Pablo Aschner, MD
First Name & Middle Initial & Last Name & Degree
Dilcia Lujan
First Name & Middle Initial & Last Name & Degree
Margot Latino
First Name & Middle Initial & Last Name & Degree
Liliana Carvajal
First Name & Middle Initial & Last Name & Degree
Patricia Barrera
First Name & Middle Initial & Last Name & Degree
Maria Ronderos

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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