Type 2 Diabetes MellitusNamasteNCT02136654
Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care
A study testing Culturally tailored diabetes program in people with Type 2 Diabetes Mellitus, run by University of British Columbia at 1 site in Canada.
Trial summary
South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Culturally tailored diabetes program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Dec 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >19 years of age
- type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes
- A1C ≥7% in past 1 year
- willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments
- ability to provide informed consent
- self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi.
Who cannot join
- life- limiting illness <12 months
- physical inability to exercise
- recurrent severe hypoglycemia or hypoglycaemic unawareness
- family member of, or living in same household as a participant
- pregnancy or gestational diabetes.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Gurpreet Oshan, BA, 778 387 3100
Nadia Khan, MD, nakhanubc@gmail.com
About this study
South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.
Read the detailed description
South Asians living in Canada and globally have high rates of chronic diseases including hypertension, type 2 diabetes (diabetes) and cardiac disease (1-3). Diabetes is arguably one of the most pressing chronic diseases among South Asian (SA) populations as it occurs at 50% higher rates in SA patients than the general population, develops 5-10 years earlier, and is one of the principal causes of premature heart attack and death in this group (1). Despite the burden of diabetes in this population, diabetes management remains poor. Under the current health care system, SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care. The study aims to recruit 600 patients with type 2 diabetes and randomize them to either a culturally tailored lifestyle and medication adherence intervention (family based, culturally tailored diabetes self management education with ongoing peer support) versus usual care on glycemic control (change in A1C level) and change in blood pressure (systolic and diastolic blood pressure) from baseline to 6 months in SA patients with poorly controlled type 2 diabetes. The NaMaSTe trial is a multi-center individual randomized controlled trial of 600 SA patients with poorly controlled diabetes (A1C ≥7%) living in British Columbia, Canada.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Culturally tailored diabetes program
- Keywords
- diabetes, ethnicity, South Asian, diabetes management
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored diabetes programBehavioural
Includes family member and peer support Includes communication training
| Study group | Role | What they receive |
|---|---|---|
| Culturally tailored diabetes program | Experimental | Culturally tailored diabetes program
* culturally tailored diabetes education
* lifestyle counselling
* medication adherence counseling
* peer supporter
* communication training
* family member involvement Receives: Behavioral: Culturally tailored diabetes program |
| Usual Care | No intervention | Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C or blood pressure (systolic or diastolic blood pressure)
Measured: within 6 months from baseline; 0, 3, and 6 months
Secondary outcomes (3)
change in fasting lipid profile
Measured: 6 months; 0 and 6 months
Change in weight or waist circumference
Measured: 6 months; 0, 3, and 6 months
change in health status
Measured: 6 months; 0, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Khan, University of British Columbia
- Investigators
- Nadia A Khan, MD MSc, Principal investigator, University of British ColumbiaTricia Tang, PhD, Principal investigator, University pf British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136654
- Sponsor's protocol ID
- H14-00693
- Acronym
- Namaste
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2014
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care
- ClinicalTrials.gov ID
- NCT02136654
- Acronym / sponsor ID
- Namaste / H14-00693
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, ethnicity, South Asian, diabetes management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 May 2014 (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.
South Asians (SA) living in Canada and globally have high rates of type 2 diabetes (diabetes). Despite the burden of diabetes in this population, diabetes management remains poor. SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care.
Detailed description
South Asians living in Canada and globally have high rates of chronic diseases including hypertension, type 2 diabetes (diabetes) and cardiac disease (1-3). Diabetes is arguably one of the most pressing chronic diseases among South Asian (SA) populations as it occurs at 50% higher rates in SA patients than the general population, develops 5-10 years earlier, and is one of the principal causes of premature heart attack and death in this group (1). Despite the burden of diabetes in this population, diabetes management remains poor. Under the current health care system, SA patients are less likely to exercise, follow a healthy diet (4), participate in exercise programs (5), and are 24% less likely to achieve glucose, blood pressure and lipid targets for diabetes than the general population (6). 55-60% of SA patients were non-adherent to their diabetes life-saving medications, compared to 30-35% non-adherence in the general population (7). This large gap in diabetes care is not surprising given language and communication barriers between primary care providers and SA patients (8-10), lack of knowledge about diabetes (8-11), preference for alternative therapies (12-14) and fundamentally different cultural beliefs on diabetes and diabetes management (15-18). Although there is some preliminary evidence that culturally tailored, chronic disease models may improve outcomes (21-24), the current evidence base is insufficient to justify the system modifications required to provide culturally tailored care across primary care settings in Canada. We propose to conduct a randomized controlled trial to assess the impact of a novel culturally tailored lifestyle and medication adherence intervention in SA patients with poorly controlled diabetes. The study is called the Novel Model for South Asian diabetes Treatment (NaMaSTe-Diabetes) trial in primary care. The study aims to recruit 600 patients with type 2 diabetes and randomize them to either a culturally tailored lifestyle and medication adherence intervention (family based, culturally tailored diabetes self management education with ongoing peer support) versus usual care on glycemic control (change in A1C level) and change in blood pressure (systolic and diastolic blood pressure) from baseline to 6 months in SA patients with poorly controlled type 2 diabetes. The NaMaSTe trial is a multi-center individual randomized controlled trial of 600 SA patients with poorly controlled diabetes (A1C ≥7%) living in British Columbia, Canada.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally tailored diabetes program | Experimental | Behavioral: Culturally tailored diabetes programCulturally tailored diabetes program * culturally tailored diabetes education * lifestyle counselling * medication adherence counseling * peer supporter * communication training * family member involvement |
| Usual Care | No intervention | –Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >19 years of age
- type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes
- A1C ≥7% in past 1 year
- willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments
- ability to provide informed consent
Key exclusion criteria (5 listed)
- life- limiting illness <12 months
- physical inability to exercise
- recurrent severe hypoglycemia or hypoglycaemic unawareness
- family member of, or living in same household as a participant
- pregnancy or gestational diabetes.
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 |
|---|---|---|
| Culturally tailored diabetes programIncludes family member and peer support Includes communication training | Behavioural | Culturally tailored diabetes program |
Primary outcome
Change in A1C or blood pressure (systolic or diastolic blood pressure)
Time frame: within 6 months from baseline; 0, 3, and 6 months
3 secondary outcomes
change in fasting lipid profile
Time frame: 6 months; 0 and 6 months
Change in weight or waist circumference
Time frame: 6 months; 0, 3, and 6 months
change in health status
Time frame: 6 months; 0, 3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
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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.
Nadia A Khan, MD MSc principal investigator
University of British Columbia
Tricia Tang, PhD principal investigator
University pf British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored diabetes program in people with Type 2 Diabetes Mellitus, run by University of British Columbia 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 6 inclusion and 5 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 27 Nov 2020. 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. 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?
Contact Gurpreet Oshan, BA (778 387 3100, gurpreetoshan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C or blood pressure (systolic or diastolic blood pressure) (time frame: within 6 months from baseline; 0, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2020.