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Cardiology
Protocol
Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico
  1. Samantha Sabo1,
  2. Catalina Denman Champion2,
  3. Melanie L Bell3,
  4. Elsa Cornejo Vucovich2,
  5. Maia Ingram1,
  6. Celina Valenica4,
  7. Maria del Carmen Castro Vasquez2,
  8. Eduardo Gonzalez-Fagoaga4,
  9. Jill Geurnsey de Zapien1,
  10. Cecilia B Rosales4
  1. 1 Department of Health Promotion Sciences, Mel & Enid Zuckerman College of Public Health University of Arizona, Tucson, Arizona, USA
  2. 2 Center for Health and Society Studies, El Colegio de Sonora, Hermosillo, Sonora, Mexico
  3. 3 Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona, USA
  4. 4 Division of Public Health Practice & Translational Research, University of Arizona Mel and Enid Zuckerman College of Public Health, Phoenix, Arizona, USA
  1. Correspondence to Dr Cecilia B Rosales; crosales{at}email.arizona.edu

Abstract

Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system.

Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors.

Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials.

Trial registration number NCT0280469; Pre-results.

  • coronary heart disease
  • general diabetes
  • public health

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020762

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    Footnotes

    • SS, CDC, MLB and CBR contributed equally.

    • Contributors SS, CDC and MLB contributed to the conceptualisation of the research design and methods and lead the writing and final review of the research protocol. ECV, MI, MdCCV, JGdZ and RBC conceptualised the research design and methods design, contributed to writing and critical review of the paper. CV and EG contributed content expertise to the study protocol and critically reviewed the final submission. CDC and RBC serve as co-principal investigators and approved final manuscript for publication.

    • Funding This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (NHLBI) grant number 1R01HL125996-01.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The Collaborative Institutional Training Initiative (CITI) for research serves to certify all research study staff on human subjects. The protocol was also approved by the Research Bioethics Committee at the University of Sonora. The University of Arizona Human Subjects Institutional Review Board has reviewed and approved the study and all affiliated activities.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.