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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universidad del Norte
- Enrollment
- 650
- Locations
- 2
- Primary Endpoint
- Reduction of body weight average at year-end structured intervention compared with the baseline.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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: Intervention_ S (Behavioral)
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: Intervention_ I (Behavioral)
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: Intervention_ C (Behavioral)
Outcomes
Primary Outcomes
Reduction of body weight average at year-end structured intervention compared with the baseline.
Time Frame: 12 Months
Reduction of body weight in kilograms
Secondary Outcomes
- Reduction of fasting glucose level at year-end intervention program (all groups) compared with baseline.(12 Months)
- Reduction of 2-hour glucose level at year-end structured and informative intervention program compared with baseline.(12 Months)
- Reduced of waist circumference average at year-end structured intervention program compared with baseline.(12 Months)