Cardiovascular DiseasesSAHARA-PilotNCT01577719
South Asian HeArt Risk Assessment Project - Pilot
A study testing Multimedia Lifestyle Improvement in people with Cardiovascular Diseases and Diabetes, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes, Abdominal Obesity
- What is being tested?
- Multimedia Lifestyle Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- South Asian Ancestry (originating from India, Pakistan, Bangladesh and Sri Lanka);
- Greater than or equal to 30 years of age;
- No previous cardiovascular disease
Who cannot join
- Not residents of Ontario
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Diabetes, Abdominal Obesity
- Being tested
- Multimedia Lifestyle Improvement, Usual Care
- Keywords
- Cardiovascular, Prevention, Ethnicity, Culture, Internet, Text Message
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia Lifestyle ImprovementBehavioural
- 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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia Lifestyle Improvement | Active comparator | Multimedia lifestyle intervention Receives: Behavioral: Multimedia Lifestyle Improvement |
| Usual Care | Placebo comparator | usual care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 6 months from randomization
Secondary outcomes (2)
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.
Measured: Baseline and at 6 months from randomization
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.
Measured: Baseline and at 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startJun 2009
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Anand, McMaster University
- Investigators
- Sonia Anand, MD, PhD, Principal investigator, McMaster University; Hamilton Health Sciences; Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577719
- Sponsor's protocol ID
- SAHARA-Pilot
- Other IDs
- NA 6865
- Acronym
- SAHARA-Pilot
- Status last verified
- Jun 2016
- First submitted
- 11 Apr 2012
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23965279
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Asian HeArt Risk Assessment Project - Pilot
- ClinicalTrials.gov ID
- NCT01577719
- Acronym / sponsor ID
- SAHARA-Pilot / SAHARA-Pilot
- Conditions
- Cardiovascular Diseases, Diabetes, Abdominal Obesity
- Keywords
- Cardiovascular, Prevention, Ethnicity, Culture, Internet, Text Message
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2012 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia Lifestyle Improvement | Active comparator | Behavioral: Multimedia Lifestyle ImprovementMultimedia lifestyle intervention |
| Usual Care | Placebo comparator | Behavioral: Usual Careusual care |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- South Asian Ancestry (originating from India, Pakistan, Bangladesh and Sri Lanka);
- Greater than or equal to 30 years of age;
- No previous cardiovascular disease
Key exclusion criteria (1 listed)
- Not residents of Ontario
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Multimedia Lifestyle Improvement |
| Usual CareParticipant will be refered to SAHARA study website to get information on healthy lifestyle and to get regular update for the course of follow-up. | Behavioural | Usual Care |
Primary outcome
Effectiveness of a 6 month culturally-specific multi-media intervention on Heart Health Risk
Time frame: Baseline and at 6 months from randomization
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.
2 secondary outcomes
Influence of knowledge of personal genetic risk for Myocardial Infarction on health behaviours
Time frame: Baseline and at 6 months from randomization
Change in the MI risk score and clinical events
Time frame: Baseline and at 6 months from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Derived from this study: PubMed 23965279Samaan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Anand, MD, PhD principal investigator
McMaster University; Hamilton Health Sciences; Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Lifestyle Improvement in people with Cardiovascular Diseases and Diabetes, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a 6 month culturally-specific multi-media intervention on Heart Health Risk (time frame: Baseline and at 6 months from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01577719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.