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)

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) .

Study Overview

• Status: Unknown
• Conditions: Prediabetic State
• Intervention / Treatment: Behavioral: Intervention_ S; Behavioral: Intervention_ I; Behavioral: Intervention_ C

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.

• Study Type: Interventional
• Enrollment (Anticipated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Acosta; Phone Number: 00573106331321; Email: tacosta@uninorte.edu.co
• Study Contact Backup: Name: Pablo Aschner; Phone Number: 00573106331321; Email: pabloaschner@gmail.com

Study Locations

• Colombia
  • Barranquilla, Colombia
    • Recruiting
    • Universidad del Norte
    • Contact: tania Acosta, MD, MPH, PhD; Phone Number: 00573106331321; Email: tacosta@uninorte.edu.co
    • Principal Investigator: Tania Acosta, MD, MPH
    • Sub-Investigator: Edgar Navarro, MD, MSC
    • Sub-Investigator: Jorge Acosta, MD, MSC
    • Sub-Investigator: Rafael Tuesca, MD, PhD, MPH
    • Sub-Investigator: Sandra Rodriguez, PhD
    • Sub-Investigator: Jesus Arroyabe, PhD
    • Sub-Investigator: Karen Florez, PhD
    • Sub-Investigator: Sara Caro, MSC
    • Sub-Investigator: Mariela Borda, MSC
  • Bogota, Colombia
    • Recruiting
    • Asociación Colombiana de Diabetes
    • Contact: Pablo Aschner, MD; Phone Number: 00573102118652; Email: pabloaschner@gmail.com
    • Principal Investigator: Pablo Aschner, MD
    • Sub-Investigator: Dilcia Lujan
    • Sub-Investigator: Margot Latino
    • Sub-Investigator: Liliana Carvajal
    • Sub-Investigator: Patricia Barrera
    • Sub-Investigator: Maria Ronderos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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)); Other Names: LIP_Structures
Experimental: 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	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); Other Names: LIP_Informative
Experimental: 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	Behavioral: Intervention_ C; One year, Intervention program at Community level. People with a FINDRISC less than 12 points; Other Names: LIP_Communitarian

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of body weight average at year-end structured intervention compared with the baseline.	Reduction of body weight in kilograms	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Reduced of waist circumference average at year-end structured intervention program compared with baseline.	Reduction of waist circumference in centimeters	12 Months

Collaborators and Investigators

• Sponsor: Universidad del Norte
• Investigators: Principal Investigator: Tania Acosta, MD, MPH, Universidad del Norte; Principal Investigator: Pablo Achner, MD, ENDOCRINOLOGIST, Asociación Colombiana de Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 55657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No