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

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ClinicalTrials.gov Identifier: NCT02804698
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
El Colegio de Sonora
Information provided by (Responsible Party):
Cecilia B Rosales, 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.


Condition or disease Intervention/treatment Phase
Diabetes Cardiovascular Disease Behavioral: Education intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
Study Start Date : August 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Meta Salud Diabetes-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.
Behavioral: Education intervention
13-week educational and physical activity intervention

No Intervention: Meta Salud Diabetes-Comparison Group
  1. 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.
  2. 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).



Primary Outcome Measures :
  1. Framingham cardiovascular disease risk [ Time Frame: 12 months ]
    Risk Scores estimate the probability that a person will develop CVD



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804698


Contacts
Contact: Cecilia B Rosales, MD 520-626-3202 crosales@email.arizona.edu

Locations
Mexico
Ministry of Health Recruiting
Hermosillo, Sonora, Mexico
Contact: Kathleen C Denman, PhD    662-259-5300    cdenman@colson.edu.mx   
Sponsors and Collaborators
University of Arizona
El Colegio de Sonora
Investigators
Principal Investigator: Cecilia B Rosales, MD, MS University of Arizona

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia B Rosales, Professor, Public Health / Assistant Dean, Phoenix Campus, University of Arizona
ClinicalTrials.gov Identifier: NCT02804698     History of Changes
Other Study ID Numbers: 1508040144
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cardiovascular Diseases