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OpenTrials
Completed

NCT Number: NCT02804698

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health

Hermosillo, Sonora, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education Intervention

Behavioral

13-week educational and physical activity intervention

Primary outcomes

  1. Framingham cardiovascular disease risk

    Time frame: 12 months

    Risk Scores estimate the probability that a person will develop CVD

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • El Colegio de Sonora

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 17, 2016
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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