South Asian HeArt Risk Assessment Project - Pilot

NCT ID: NCT01577719

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30

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) Pilot, is to recruit 400 South Asians from Ontario, who use the internet, email and other multimedia devices. Among these participants the investigators will compare the effectiveness of a 6-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.

Detailed Description

Introduction: Coronary heart disease (CHD) remains the major cause of disease burden globally, and the rising prevalence of overweight, 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. 400 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 6 months after and the effectiveness of this intervention will be evaluated using the change in the cardiac risk score after 6 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 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.

Conditions

Cardiovascular Diseases; Diabetes; Abdominal Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multimedia Lifestyle Improvement

Multimedia lifestyle intervention

Group Type: ACTIVE_COMPARATOR

Multimedia Lifestyle Improvement

Intervention Type: BEHAVIORAL

• Online 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.
• Bi-weekly email reminder to report back on the current lifestyle goal and choose the next goal for upcoming 2 weeks.

Usual Care

usual care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

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.

Interventions

Multimedia Lifestyle Improvement

• Online 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.
• Bi-weekly email reminder to report back on the current lifestyle goal and choose the next goal for upcoming 2 weeks.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

Exclusion Criteria

• Not residents of Ontario

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Sonia Anand

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Anand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University; Hamilton Health Sciences; Population Health Research Institute

Locations

Population Health Research Institute

Hamilton, Ontario, Canada

Countries

Canada

References

Samaan Z, Schulze KM, Middleton C, Irvine J, Joseph P, Mente A, Shah BR, Pare G, Desai D, Anand SS; SAHARA Investigators. South Asian Heart Risk Assessment (SAHARA): Randomized Controlled Trial Design and Pilot Study. JMIR Res Protoc. 2013 Aug 20;2(2):e33. doi: 10.2196/resprot.2621.

Reference Type: DERIVED

PMID: 23965279 (View on PubMed)

Other Identifiers

NA 6865

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAHARA-Pilot

Identifier Type: -

Identifier Source: org_study_id