title: South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  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. 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01577719; http://clinicaltrials.gov/ct2/show/NCT01577719 (Archived by WebCite at http://www.webcitation.org/6J11uYXgJ).
authors: Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, ON, Canada.
authors: Zainab
authors: Z
authors: Samaan
authors: Karleen M
authors: KM
authors: Schulze
authors: Catherine
authors: C
authors: Middleton
authors: Jane
authors: J
authors: Irvine
authors: Phillip
authors: P
authors: Joseph
authors: Andrew
authors: A
authors: Mente
authors: Baiju R
authors: BR
authors: Shah
authors: Guillaume
authors: G
authors: Pare
authors: Dipika
authors: D
authors: Desai
authors: Sonia S
authors: SS
authors: Anand
keywords: South Asians; assessment; health; multimedia; randomized; risk; trial
references: Lancet. 2000 Jul 22;356(9226):279-84
references: 11071182
references: J Med Internet Res. 2010 Feb 17;12(1):e4
references: 20164043
references: Cardiol Rev. 2006 Mar-Apr;14(2):74-80
references: 16493244
references: Can J Cardiol. 2013 Feb;29(2):151-67
references: 23351925
references: JAMA. 2007 Jan 17;297(3):286-94
references: 17227980
references: Am Psychol. 2002 Sep;57(9):705-17
references: 12237980
references: Tob Control. 2006 Feb;15(1):7-12
references: 16436397
references: J Gen Intern Med. 2013 Apr;28(4):554-60
references: 23143672
references: Heart. 2007 Oct;93(10):1175
references: 17890692
references: Arch Intern Med. 1993 Aug 23;153(16):1869-78
references: 8250648
references: Cochrane Database Syst Rev. 2010 Oct 06;(10):CD007275
references: 20927756
references: Diabetologia. 2005 Apr;48(4):649-56
references: 15759110
references: J Med Internet Res. 2011 Dec 31;13(4):e126
references: 22209829
references: J Psychiatr Res. 2008 Jan;42(1):1-21
references: 17275026
references: Circulation. 2001 Dec 4;104(23):2855-64
references: 11733407
references: Eur J Heart Fail. 2007 Nov;9(11):1095-103
references: 17888721
references: J Health Psychol. 2008 May;13(4):481-94
references: 18420756
references: PLoS Med. 2011 Oct;8(10):e1001106
references: 22022235
references: Ann Behav Med. 2012 Feb;43(1):62-73
references: 22246660
references: Science. 2007 Jun 8;316(5830):1488-91
references: 17478681
references: J Med Internet Res. 2006 Mar 30;8(1):e3
references: 16585028
references: Med Decis Making. 2012 Jul-Aug;32(4):606-15
references: 22247420
references: BMJ. 2004 Aug 21;329(7463):435-8
references: 15321902
references: Eur Heart J. 2011 Mar;32(5):581-9
references: 21177699
references: J Consult Clin Psychol. 1983 Jun;51(3):390-5
references: 6863699
references: J Behav Med. 2008 Apr;31(2):169-77
references: 18165893
references: J Behav Med. 1987 Oct;10(5):481-500
references: 3430590
references: Prev Med. 2009 Jan;48(1):25-31
references: 19022282
references: J Med Internet Res. 2004 Nov 10;6(4):e40
references: 15631964
references: AIDS. 2011 Mar 27;25(6):825-34
references: 21252632
references: Circulation. 2008 Sep 2;118(10):993-1001
references: 18711012
references: Science. 2007 Jun 8;316(5830):1491-3
references: 17478679
references: Am J Addict. 2004 Mar-Apr;13(2):103-19
references: 15204662
references: J Med Internet Res. 2008 Nov 25;10(5):e49
references: 19033148
references: Circulation. 2007 Apr 24;115(16):2111-8
references: 17420343
references: Addiction. 2009 Dec;104(12):2023-32
references: 19922569
references: BMJ. 2004 Aug 21;329(7463):439-42
references: 15321903
references: N Engl J Med. 2011 Feb 10;364(6):524-34
references: 21226570
references: Am Psychol. 1992 Sep;47(9):1102-14
references: 1329589
references: Lancet. 2006 May 27;367(9524):1747-57
references: 16731270
references: Annu Rev Public Health. 2010;31:89-103
references: 20070198
references: Epidemiol Rev. 2010;32:56-69
references: 20354039
references: Circulation. 2008 Apr 1;117(13):1675-84
references: 18362232
references: CMAJ. 2010 May 18;182(8):E301-10
references: 20403888
references: Int J Obes (Lond). 2012 May;36(5):675-85
references: 21694698
references: Diabetologia. 2006 Nov;49(11):2580-8
references: 16972045
references: Psychol Med. 2007 Mar;37(3):319-28
references: 17112400