Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arizona
- Enrollment
- 518
- Locations
- 1
- Primary Endpoint
- Framingham cardiovascular disease risk
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Meta Salud Diabetes-Intervention
- Attend the thirteen weekly educational classes and physical activity group (prior physician approval) that are part of the Meta Salud Diabetes program.
- 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.
- 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).
- 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.
Intervention: Education intervention (Behavioral)
Meta Salud Diabetes-Comparison Group
- 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.
- Respond to a survey about your nutrition and physical activity habits on three separate occasions (you will answer the first survey as soon as you finish reading and agree to participate by signing this form, the second survey will be three months from now, and the third survey will be 12 months from now).
Outcomes
Primary Outcomes
Framingham cardiovascular disease risk
Time Frame: 12 months
Risk Scores estimate the probability that a person will develop CVD
Secondary Outcomes
No secondary outcomes reported
Investigators
Cecilia B Rosales
Professor, Public Health / Assistant Dean, Phoenix Campus
University of Arizona