TY - JOUR
T1 - Meta Salud Diabetes study protocol
T2 - A cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico
AU - Sabo, Samantha
AU - Denman Champion, Catalina
AU - Bell, Melanie L.
AU - Cornejo Vucovich, Elsa
AU - Ingram, Maia
AU - Valenica, Celina
AU - Del Carmen Castro Vasquez, Maria
AU - Gonzalez-Fagoaga, Eduardo
AU - Geurnsey De Zapien, Jill
AU - Rosales, Cecilia B.
N1 - Funding Information:
Acknowledgements We would like to acknowledge the Ministry of Health of Sonora, Mexico, for their commitment to participating in this study designed to improve the health of their patients with diabetes. 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.
Funding Information:
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.
Funding Information:
The Meta Salud Diabetes (MSD) curriculum was designed by El Colegio de Sonora and the University of Arizona as part of ‘Tools and practices to reduce CVD and complications in the diabetic population in Mexico’, a project funded by the National Institutes of Health (NIH) National Heart, Lung and Blood Institute as part of the Global Alliance for Chronic Diseases. The MSD behavioural intervention aims to reduce clinical risks for developing CVD among diabetic populations and is implemented in collaboration with the Sonora Ministry of Health. The research study’s two primary objectives are: (1) to test the effectiveness of a CVD secondary prevention intervention among a diabetic population and (2) engage in a study that assesses the implementation of the MSD intervention to identify the strengths and limitations faced by each study affiliated clinical site.
Publisher Copyright:
© 2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article). All rights reserved.
PY - 2018/3/1
Y1 - 2018/3/1
N2 - 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.
AB - 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.
KW - coronary heart disease
KW - general diabetes
KW - public health
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U2 - 10.1136/bmjopen-2017-020762
DO - 10.1136/bmjopen-2017-020762
M3 - Article
C2 - 29530914
AN - SCOPUS:85044179338
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e020762
ER -