South Asian HeArt Risk Assessment Project - Trial (SAHARA-Trial)
SAHARA
2 other identifiers
interventional
343
1 country
1
Brief Summary
People who originate from the Indian subcontinent known as South Asians are the fastest growing group of non-white Canadians. They suffer an excess prevalence of abdominal obesity, type 2 diabetes and heart disease. They also develop these risk factors at significantly lower body weight and at younger ages compared to people of European origin. The purpose of SAHARA (South Asian HeArt Risk Assessment) Trial, is to recruit 330 South Asians from Ontario (Principal Investigator: Dr. Sonia Anand) and British Columbia (Co-investigator: Dr. Scott Lear), who use the internet, email and other multimedia devices. Among these participants, the investigators will compare the effectiveness of a 12-month interactive multi-media health behaviour intervention to usual care in reducing cardiac risk factors. This intervention enables participants to set their health goals and provides health messaging and feedback designed to improve their smoking, dietary habits and physical activity. In addition, the investigators will test if knowledge of genetic risk for heart attack influences behaviour change and their heart health risk factor profile. The information generated from SAHARA will enable individuals, physicians, health professionals, and policy makers to develop risk factor modification programs to prevent cardiovascular disease in this high-risk group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJune 9, 2016
June 1, 2016
2.5 years
April 18, 2013
June 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of a 12 Month Culturally-Specific Multi-media Intervention on Heart Health Risk
To test the effectiveness of a 12 month culturally-specific multi-media intervention which provides health messaging and feedback regarding optimal strategies for individuals greater than 30 years to improve their dietary habits, sedentary behaviours, physical activity, and tobacco use. Outcome measure (heart risk score) will be assessed based on the Interheart Modifiable Risk Score assessed at baseline and 12 months from randomization
Baseline and 12 months from randomization
Secondary Outcomes (3)
Influence of Knowledge of Personal Genetic Risk for Myocardial Infarction on Health Behaviours
Baseline and 12 months from randomization
Change in Diabetes Status
Baseline and 12 months from randomization
Change in Hypertension Status
Baseline and 12 months from randomization
Study Arms (2)
Multimedia Lifestyle Improvement
ACTIVE COMPARATORIncludes goal setting, self monitoring and participants will receive regular health messaging using electronic media regarding smoking, dietary habits \& physical activity
Usual Care
PLACEBO COMPARATORIncludes usual advice and no regular health messaging.
Interventions
* Goal setting to improve diet, physical activity or smoking behaviours * Regular health messaging related to the participant's goal, sent by email or text messaging, based on participant preference.
Participant will be refered to SAHARA study website to get information on healthy lifestyle and to get regular update for the course of follow-up.
Eligibility Criteria
You may qualify if:
- South Asian Ancestry (originating from India, Pakistan, Bangladesh and Sri Lanka);
- Greater than or equal to 30 years of age;
- No previous cardiovascular disease
- Provided an email address
You may not qualify if:
- Another member in household is enrolled in SAHARA
- Currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Population Health Research Institute
Hamilton, Ontario, L8L 2X2, Canada
Related Publications (1)
Anand SS, Samaan Z, Middleton C, Irvine J, Desai D, Schulze KM, Sothiratnam S, Hussain F, Shah BR, Pare G, Beyene J, Lear SA; South Asian Heart Risk Assessment Investigators. A Digital Health Intervention to Lower Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):601-6. doi: 10.1001/jamacardio.2016.1035.
PMID: 27438754DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonia Anand, MD, PhD
McMaster University; Hamilton Health Sciences; Population Health Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 26, 2013
Study Start
June 1, 2012
Primary Completion
December 1, 2014
Last Updated
June 9, 2016
Record last verified: 2016-06