Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico
Denman Champion, Catalina
Bell, Melanie L
Cornejo Vucovich, Elsa
Castro Vasquez, Maria del Carmen
Geurnsey de Zapien, Jill
Rosales, Cecilia B
AffiliationUniv Arizona, Mel & Enid Zuckerman Coll Publ Hlth, Dept Hlth Promot Sci
Univ Arizona, Dept Epidemiol & Biostat, Mel & Enid Zuckerman Coll Publ Hlth
Univ Arizona, Div Publ Hlth Practice & Translat Res, Mel & Enid Zuckerman Coll Publ Hlth
MetadataShow full item record
PublisherBMJ PUBLISHING GROUP
CitationSabo S, Denman Champion C, Bell ML, et al Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico BMJ Open 2018;8:e020762. doi: 10.1136/bmjopen-2017-020762
Rights© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license.
Collection InformationThis item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at firstname.lastname@example.org.
AbstractIntroduction 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.
NoteOpen access journal.
VersionFinal published version
SponsorsNational Institutes of Health, National Heart Lung and Blood Institute (NHLBI) [1R01HL125996-01]
- Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.
- Authors: Jha D, Gupta P, Ajay VS, Jindal D, Perel P, Prieto-Merino D, Jacob P, Nyong J, Venugopal V, Singh K, Goenka S, Roy A, Tandon N, Patel V, Prabhakaran D
- Issue date: 2017 Aug 11
- Behavioural interventions for type 2 diabetes: an evidence-based analysis.
- Authors: Medical Advisory Secretariat.
- Issue date: 2009
- Rationale and methods of a multicentre randomised controlled trial of the effectiveness of a Community Health Assessment Programme with Emergency Medical Services (CHAP-EMS) implemented on residents aged 55 years and older in subsidised seniors' housing buildings in Ontario, Canada.
- Authors: Agarwal G, McDonough B, Angeles R, Pirrie M, Marzanek F, McLeod B, Dolovich L
- Issue date: 2015 Jun 11
- Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes.
- Authors: Huo X, Spatz ES, Ding Q, Horak P, Zheng X, Masters C, Zhang H, Irwin ML, Yan X, Guan W, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM, Jiang L
- Issue date: 2017 Dec 21
- Cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of an obesity prevention programme for Chinese primary school-aged children: the CHIRPY DRAGON study protocol.
- Authors: Li B, Liu WJ, Adab P, Pallan M, Hemming K, Frew E, Lin R, Martin J, Liu W, Cheng KK
- Issue date: 2017 Dec 1