Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico
1 other identifier
interventional
518
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Aug 2016
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMay 4, 2021
April 1, 2021
2.7 years
June 14, 2016
April 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Framingham cardiovascular disease risk
Risk Scores estimate the probability that a person will develop CVD
12 months
Study Arms (2)
Meta Salud Diabetes-Intervention
EXPERIMENTAL1. 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.
Meta Salud Diabetes-Comparison Group
NO INTERVENTION1. 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).
Interventions
13-week educational and physical activity intervention
Eligibility Criteria
You may qualify if:
- adults ≥18 years old
- have been diagnosed with controlled or uncontrolled diabetes
You may not qualify if:
- \< than 18 years of age
- not diagnosed with diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- El Colegio de Sonoracollaborator
Study Sites (1)
Ministry of Health
Hermosillo, Sonora, Mexico
Related Publications (5)
Aceves B, Denman CA, Ingram M, Torres JF, Nuno T, Garcia DO, Madhivanan P, Rosales CB. Testing Scalability of a Diabetes Self-Management Intervention in Northern Mexico: An Ecological Approach. Front Public Health. 2021 Aug 18;9:617468. doi: 10.3389/fpubh.2021.617468. eCollection 2021.
PMID: 34490173DERIVEDAceves B, Ruiz M, Ingram M, Denman C, Garcia DO, Madhivanan P, Rosales C. Mental health and diabetes self-management: assessing stakeholder perspectives from health centers in Northern Mexico. BMC Health Serv Res. 2021 Feb 25;21(1):177. doi: 10.1186/s12913-021-06168-y.
PMID: 33632205DERIVEDBell ML, Rabe BA. The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data. Trials. 2020 Feb 7;21(1):148. doi: 10.1186/s13063-020-4114-9.
PMID: 32033617DERIVEDIngram M, Denman CA, Cornejo-Vucovich E, Castro-Vasquez MDC, Aceves B, Ocejo AG, de Zapien JG, Rosales C. The Meta Salud Diabetes Implementation Study: Qualitative Methods to Assess Integration of a Health Promotion Intervention Into Primary Care to Reduce CVD Risk Among an Underserved Population With Diabetes in Sonora, Mexico. Front Public Health. 2019 Nov 15;7:347. doi: 10.3389/fpubh.2019.00347. eCollection 2019.
PMID: 31803710DERIVEDSabo S, Denman Champion C, Bell ML, Cornejo Vucovich E, Ingram M, Valenica C, Castro Vasquez MDC, Gonzalez-Fagoaga E, Geurnsey de Zapien J, Rosales CB. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico. BMJ Open. 2018 Mar 12;8(3):e020762. doi: 10.1136/bmjopen-2017-020762.
PMID: 29530914DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilia B Rosales, MD, MS
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Public Health / Assistant Dean, Phoenix Campus
Study Record Dates
First Submitted
June 14, 2016
First Posted
June 17, 2016
Study Start
August 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2020
Last Updated
May 4, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share