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

Primary Purpose

Cardiovascular Diseases, Diabetes, Abdominal Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multimedia Lifestyle Improvement
Usual Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Cardiovascular, Prevention, Ethnicity, Culture, Internet, Text Message

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Population Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Multimedia Lifestyle Improvement

Usual Care

Arm Description

Multimedia lifestyle intervention

usual care

Outcomes

Primary Outcome Measures

Effectiveness of a 6 month culturally-specific multi-media intervention on Heart Health Risk
To test the effectiveness of a 6 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.

Secondary Outcome Measures

Influence of knowledge of personal genetic risk for Myocardial Infarction on health behaviours
To determine if knowledge of personal genetic risk for Myocardial Infarction (MI)and Diabetes influences the health behaviours associated with MI risk factors.
Change in the MI risk score and clinical events
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 time in all people screened for entry into the randomized intervention.

Full Information

First Posted
April 11, 2012
Last Updated
June 8, 2016
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT01577719
Brief Title
South Asian HeArt Risk Assessment Project - Pilot
Acronym
SAHARA-Pilot
Official Title
South Asian HeArt Risk Assessment Project - Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. To test if knowledge of genetic risk for MI as determined by the 9p21 variant genotype influences behaviour change and MI risk factor profile. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes, Abdominal Obesity
Keywords
Cardiovascular, Prevention, Ethnicity, Culture, Internet, Text Message

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multimedia Lifestyle Improvement
Arm Type
Active Comparator
Arm Description
Multimedia lifestyle intervention
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
Multimedia Lifestyle Improvement
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of a 6 month culturally-specific multi-media intervention on Heart Health Risk
Description
To test the effectiveness of a 6 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.
Time Frame
Baseline and at 6 months from randomization
Secondary Outcome Measure Information:
Title
Influence of knowledge of personal genetic risk for Myocardial Infarction on health behaviours
Description
To determine if knowledge of personal genetic risk for Myocardial Infarction (MI)and Diabetes influences the health behaviours associated with MI risk factors.
Time Frame
Baseline and at 6 months from randomization
Title
Change in the MI risk score and clinical events
Description
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 time in all people screened for entry into the randomized intervention.
Time Frame
Baseline and at 6 months from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Anand, MD, PhD
Organizational Affiliation
McMaster University; Hamilton Health Sciences; Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Population Health Research Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23965279
Citation
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.
Results Reference
derived

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South Asian HeArt Risk Assessment Project - Pilot

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