South Asian HeArt Risk Assessment Project - Trial (SAHARA-Trial)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
Sonia Anand, McMaster University
ClinicalTrials.gov Identifier:
NCT01841398
First received: April 18, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Diabetes
Abdominal Obesity
Behavioral: Multimedia Lifestyle Improvement
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: South Asian HeArt Risk Assessment Project - Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Effectiveness of a 12 Month Culturally-Specific Multi-media Intervention on Heart Health Risk [ Time Frame: Baseline and 12 months from randomization ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Influence of Knowledge of Personal Genetic Risk for Myocardial Infarction on Health Behaviours [ Time Frame: Baseline and 12 months from randomization ] [ Designated as safety issue: No ]

    To determine if knowledge of personal genetic risk for Myocardial Infarction (MI)and Diabetes influences the health behaviours associated with MI risk factors.

    Outcome measure (health behaviour) will be assessed from participants' self-reported questionnaire at baseline and 12 months from randomization


  • Change in Diabetes Status [ Time Frame: Baseline and 12 months from randomization ] [ Designated as safety issue: No ]

    To determine the change in diabetes status.

    Outcome measure (diabetes status) will be assessed from results from participants' self-reported questionnaires and bloodwork at baseline and 12 months from randomization.


  • Change in Hypertension Status [ Time Frame: Baseline and 12 months from randomization ] [ Designated as safety issue: No ]

    To determine the change in hypertension status.

    Outcome measure (hypertension status) will be assessed from results from the participants' self-reported questionnaires and physical measurements at baseline and 12 months from randomization.



Estimated Enrollment: 330
Study Start Date: June 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multimedia Lifestyle Improvement
Includes goal setting, self monitoring and participants will receive regular health messaging using electronic media regarding smoking, dietary habits & physical activity
Behavioral: Multimedia Lifestyle Improvement
  • 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.
Placebo Comparator: Usual Care
Includes usual advice and no regular health messaging.
Behavioral: Usual Care
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.

Detailed Description:

Introduction: Coronary heart disease (CHD) remains the major cause of disease burden globally, and the rising prevalence of obesity and adult onset diabetes is predicted to potentiate the CHD epidemic in developing countries, and in high risk populations, including people who originate from the Indian subcontinent (South Asians). More than 1.2 million people of South Asian origin live in Canada and they are the fastest growing group of non-white Canadians. Our previous work among South Asians has shown that, compared to white Caucasians in Canada, they suffer from a 2.5 times excess prevalence of elevated glucose (dysglycemia), and CHD. They also develop abnormal glucose, lipids (elevated apolipoprotein B & reduced apolipoprotein Al) and blood pressure at significantly lower body mass index values compared to white Caucasians (21 vs. 30). Successful interventions which prevent or improve myocardial infarction (MI) risk factors among South Asians are urgently needed.

Objectives: Among South Asian men and women ≥ 30 years who live in Canada we propose:

  1. To test the effectiveness of a culturally-tailored multimedia intervention designed to improve health behaviours including dietary habits, sedentary behaviours, physical activity, and tobacco use, in order to improve their MI risk factor profile.
  2. To test if knowledge of genetic risk for MI as determined by the 9p21 variant genotype influences behaviour change and MI risk factor profile.
  3. To determine the change in the MI risk score and clinical events including MI, death, development of new diabetes, and development of new hypertension over the 6 months follow-up.

Design & Methods: People of South Asian ancestry defined as people whose ancestors originate from the Indian subcontinent (India, Pakistan, Bangladesh and Sri Lanka) ≥ 30 years age will be eligible for SAHARA. Subjects with no access to e-mail, text messaging or smart phones and who have suffered previous coronary heart disease will be excluded. 330 subjects will undergo a brief cardiac risk factor assessment including collection of data on questionnaire, physical measurement (i.e. weight, height, waist and hip circumference, and blood pressure), and a blood sample will be collected to measure apolipoproteins and glucose. All eligible and consenting subjects will be randomized 1:1 to intervention versus control. The intervention group will include goal setting, self monitoring and participants will receive regular health messaging using electronic media regarding smoking, dietary habits & physical activity. The control group will receive usual advice and no regular health messaging. The intervention will last for 12 months after randomization and the effectiveness of this intervention will be evaluated using the change in the cardiac risk score after 12 months.

Summary: South Asians are the fastest growing group of Canadians. They suffer an excess prevalence of cardiac risk factors and MI at a younger age compared to people of European origin. The SAHARA project will enable us to use simple but validated tools to assess the MI risk profile among South Asian men and women from Ontario and British Columbia, and we will test a culturally-tailored multimedia intervention to determine if improvement in the MI risk factor profile can be achieved and sustained. If this intervention is successful it will be easily scalable, and has the potential to be delivered to a large proportion of the South Asian community in Canada.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Another member in household is enrolled in SAHARA
  • Currently pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841398

Contacts
Contact: Dipika Desai, MSc 905-527-4322 ext 40378 dipika.desai@phri.ca

Locations
Canada, Ontario
Population Health Research Institute Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Dipika Desai, M.Sc    905-527-4322 ext 40378    dipika.desai@phri.ca   
Principal Investigator: Sonia Anand, MD, PhD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Sonia Anand, MD, PhD McMaster University; Hamilton Health Sciences; Population Health Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Sonia Anand, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01841398     History of Changes
Other Study ID Numbers: SAHARA- Trial, MOP 123309
Study First Received: April 18, 2013
Last Updated: April 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Cardiovascular
Prevention
Ethnicity
Culture
Internet
Text Message

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity, Abdominal
Nutrition Disorders
Obesity
Overnutrition

ClinicalTrials.gov processed this record on October 23, 2014