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Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico

Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02804698
Enrollment
518
Registered
2016-06-17
Start date
2016-08-31
Completion date
2020-05-31
Last updated
2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes

Brief summary

This project will look to improve standards of care for diabetic patients by evaluating a program that supports participants in making healthy lifestyle changes. The program consists of 13 educational sessions that contain information about the prevention and care of diabetes and cardiovascular disease, physical activity, nutrition, community health and emotional well being.

Detailed description

Researchers propose to address extremely high rates of cardiovascular disease morbidity and mortality in Sonora, Mexico through use of an evidence-based community health worker intervention for adult patients with diabetes who receive care at health centers operated by the Secretaría de Salud, an office of the Mexican government. Researchers will conduct a cluster-randomized trial with a total of 400 patients at 20 health centers to understand whether the 13-week educational intervention, Meta Salud Diabetes, can effectively reduce clinical, behavioral, and psychosocial risk for cardiovascular disease among adults with diabetes. Researchers will also conduct an implementation study that will consist of systematic engagement of local, state and national decision makers to identify barriers, facilitators, and strategies to adopt and integrate community health worker-led cardiovascular disease prevention interventions throughout the 209 health centers in Sonora.

Interventions

BEHAVIORALEducation intervention

13-week educational and physical activity intervention

Sponsors

El Colegio de Sonora
CollaboratorUNKNOWN
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults ≥18 years old * have been diagnosed with controlled or uncontrolled diabetes

Exclusion criteria

* \< than 18 years of age * not diagnosed with diabetes

Design outcomes

Primary

MeasureTime frameDescription
Framingham cardiovascular disease risk12 monthsRisk Scores estimate the probability that a person will develop CVD

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026