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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Diabetes
• Interventions: Behavioral: Education intervention

• Registration Number: NCT02804698
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Study Start: 2016-08
• Primary Completion: 2019-05
• Study Completion: 2020-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meta Salud Diabetes-Intervention	Education intervention	1. Attend the thirteen weekly educational classes and physical activity group (prior physician approval) that are part of the Meta Salud Diabetes program. 2. Allow the research staff to collect your cholesterol, glucose, A1c, triglyceride levels, as well as your blood pressure, height, weight, and waist and hip circumference. 3. Respond to a survey about your nutrition and physical activity habits on three separate occasions (at the start of the 13-week program, just after you finish the program, and nine months after you finish the program). 4. You may also be invited to participate in a follow-up interview, where you will be asked about your experience during and after the Meta Salud Diabetes program.

Primary Outcome Measures

Name	Time	Method
Framingham cardiovascular disease risk	12 months	Risk Scores estimate the probability that a person will develop CVD

Trial Locations

Locations (1)

Ministry of Health; 🇲🇽 Hermosillo, Sonora, Mexico