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      South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study

      , MBChB, MSc, PhD, MRCPsych 1 , 2 , 3 , 4 , , MMath 4 , , PhD 5 , , DPhil, CPsych 6 , , MD 4 , , PhD 2 , 3 , 4 , , MD, PhD 7 , , MD, MSc 2 , 4 , 8 , , MSc 2 , 4 , , MD, PhD, FRCPc 2 , 3 , 4 , 9 , , SAHARA Investigators 2
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications Inc.
      multimedia, South Asians, health, risk, assessment, randomized, trial

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          People of South Asian origin suffer a high burden of premature myocardial infarction (MI). South Asians form a growing proportion of the Canadian population and preventive strategies to mitigate the risk of MI in this group are needed. Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes among the obese, smokers, and among those who are sedentary.


          Among at-risk South Asians living in Canada, our objectives are to determine: (1) the feasibility of a culturally tailored multimedia intervention to induce positive behavioral changes associated with reduced MI risk factors, and (2) the effectiveness and acceptability of information communicated by individualized MI and genetic risk score (GRS) reports.


          The South Asian HeArt Risk Assessment (SAHARA) pilot study enrolled 367 individuals of South Asian origin recruited from places of worship and community centers in Ontario, Canada. MI risk factors including the 9p21 genetic variant status were provided to all participants after the baseline visit. Participants were randomly allocated to receive a multimedia intervention or control. The intervention group selected health goals and received personalized health messages to promote adherence to their selected goals. After 6 months, all participants had their MI risk factors repeated. The methods and results of this study are reported based on the CONSORT-EHEALTH guidelines.


          The mean age of participants was 53.8 years (SD 11.4), 52.0% (191/367) were women, and 97.5% (358/367) were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% (269/367) had one or two copies of the risk allele for the 9p21 genetic variant. Both the intervention and control groups made some progress in health behavior changes related to diet and physical activity over 6 months. Participants reported that their risk score reports motivated behavioral changes, although half of the participants could not recall their risk scores at the end of study evaluation. Some components of the multimedia intervention were not widely used such as logging onto the website to set new health goals, and participants requested having more personal interactions with the study team.


          Some, but not all, components of the multimedia intervention are feasible and have the potential to induce positive health behavior changes. MI and GRS reports are desired by participants although their impact on inducing sustained health behavior change requires further evaluation. Information generated from this pilot study has directly informed the design of another randomized trial designed to reduce MI risk among South Asians.

          Trial Registration

          ClinicalTrials.gov NCT01577719; http://clinicaltrials.gov/ct2/show/NCT01577719 (Archived by WebCite at http://www.webcitation.org/6J11uYXgJ).

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          Most cited references37

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              In search of how people change. Applications to addictive behaviors.

              How people intentionally change addictive behaviors with and without treatment is not well understood by behavioral scientists. This article summarizes research on self-initiated and professionally facilitated change of addictive behaviors using the key trans-theoretical constructs of stages and processes of change. Modification of addictive behaviors involves progression through five stages--pre-contemplation, contemplation, preparation, action, and maintenance--and individuals typically recycle through these stages several times before termination of the addiction. Multiple studies provide strong support for these stages as well as for a finite and common set of change processes used to progress through the stages. Research to date supports a trans-theoretical model of change that systematically integrates the stages with processes of change from diverse theories of psychotherapy.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                Jul-Dec 2013
                20 August 2013
                : 2
                : 2
                : e33
                [1] 1Department of Psychiatry and Behavioral Neurosciences McMaster University Hamilton, ONCanada
                [2] 2Population Genomics Program, Chanchlani Research Centre McMaster University Hamilton, ONCanada
                [3] 3Department of Clinical Epidemiology and Biostatistics McMaster University Hamilton, ONCanada
                [4] 4Population Health Research Institute McMaster University and Hamilton Health Sciences Hamilton, ONCanada
                [5] 5Ryerson University Toronto, ONCanada
                [6] 6York University Toronto, ONCanada
                [7] 7Evaluative Clinical Sciences, Schulich Heart Research Program, Sunnybrook Research Institute University of Toronto Toronto, ONCanada
                [8] 8McMaster University Pathology and Molecular Medicine Hamilton, ONCanada
                [9] 9Department of Medicine McMaster University Hamilton, ONCanada
                Author notes
                Corresponding Author: Sonia S Anand anands@ 123456mcmaster.ca
                ©Zainab Samaan, Karleen M Schulze, Catherine Middleton, Jane Irvine, Phillip Joseph, Andrew Mente, Baiju R Shah, Guillaume Pare, Dipika Desai, Sonia S Anand, SAHARA Investigators. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.08.2013.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 16 March 2013
                : 11 June 2013
                : 01 July 2013
                : 29 July 2013
                Original Paper

                multimedia,south asians,health,risk,assessment,randomized,trial
                multimedia, south asians, health, risk, assessment, randomized, trial


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