CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Background: People of South Asian origin suffer a high burden of premature myocardial infarction (MI). Prior studies have shown that multimedia interventions are effective and feasible in inducing health behavior changes. Objectives: 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 reports. 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT 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 six months all participants had their MI risk factors repeated. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Methods: 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. 1b-iv) RESULTS section in abstract must contain use data Results: The mean age of participants was 53.8 years (SD 11.4), 52% were women, and 97.5% were immigrants to Canada. The mean INTERHEART risk score was 13.0 (SD 5.8) and 73.3% 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 six 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. 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions: Some, but not all, components of a multimedia intervention are feasible and have the potential to induce positive health behavior changes. MI and genetic risk score 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 a larger randomized trial designed to reduce MI risk among South Asians. INTRODUCTION 2a-i) Problem and the type of system/solution Myocardial infarction (MI) due to coronary artery disease (CAD) remains a major cause of death globally.[1] The rising prevalence of overweight, obesity and type 2 diabetes is predicted to potentiate the CAD epidemic in developing countries.[2] South Asians, people who originate from the Indian subcontinent, suffer a high burden of premature MI,[3, 4] and are projected to account for 40% of the global CAD burden by 2020.[5] More than 1.2 million South Asians live in Canada and are the fastest growing group of non-white Canadians.[6] Several studies have shown that multimedia interventions to manage risk factors of common disorders and to modify health behaviours are effective.[915] Multimedia interventions include use of email messaging, text messaging, video or computer based education and electronic personalized health records, which are attractive because they involve components of goal setting and feedback – key components of health behavior modification, are relatively cost efficient, and have the potential to be scalable to large numbers of individuals.[16-21] 2a-ii) Scientific background, rationale: What is known about the (type of) system The use of MI risk tools to guide risk factor modification in cardiovascular prevention is increasing.[22] More recently the addition of genetic information into these risk tools has been evaluated. This has been made possible by the recent large-scale genetic studies that have identified common genetic variants associated with MI risk. The most robust genetic variant associated with increased risk for MI is a common polymorphism located on the short arm of chromosome 9 (9p21).[23, 24] This genetic variant is common in the general population, with 50% of people carrying one copy of the risk allele, which increases MI by 15-20%, and 25% of the population carrying two copies of the risk allele, which increases MI risk by 30-40%.[25] Further there is evidence to suggest that the MI risk associated with 9p21 may be modified by healthy dietary patterns.[26] While some recent studies have evaluated whether knowledge of genetic risk of a condition influences individuals’ behavior change,[27, 28] the results remain inconclusive. To our knowledge there have been no multimedia health behavior modification interventions, which have incorporated genetic risk information among South Asians at risk for MI. METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio To address this gap we conducted a pilot study, the South Asian HeArt Risk Assessment (SAHARA) among at risk South Asians living in Canada, to test: 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 reports. Information generated from the SAHARA pilot will directly inform the design of a larger randomized trial designed to test the effectiveness of this intervention to reduce MI risk among South Asians. 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No changes were made as this is the pilot phase of the trial. Changes to the main trial are proposed in the manuscript based on experience gained from pilot study. 3b-i) Bug fixes, Downtimes, Content Changes