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Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care

Novel Model for South Asian Treatment in Diabetes (NaMaSTe-Diabetes) Trial in Primary Care

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136654
Acronym
Namaste
Enrollment
600
Registered
2014-05-13
Start date
2015-07-31
Completion date
2021-12-31
Last updated
2020-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, ethnicity, South Asian, diabetes management

Brief 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. 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.

Interventions

BEHAVIORALCulturally tailored diabetes program

Includes family member and peer support Includes communication training

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frame
Change in A1C or blood pressure (systolic or diastolic blood pressure)within 6 months from baseline; 0, 3, and 6 months

Secondary

MeasureTime frame
change in fasting lipid profile6 months; 0 and 6 months
Change in weight or waist circumference6 months; 0, 3, and 6 months
change in health status6 months; 0, 3, and 6 months

Other

MeasureTime frameDescription
Procedure related outcomes6 months; 0, 3, and 6 monthshealth behaviours, medication adherence, patient engagement/activation, diabetes management, diabetes distress, depression, social support, knowledge, motivation, self efficacy.

Countries

Canada

Contacts

Primary ContactGurpreet Oshan, BA
gurpreetoshan@gmail.com778 387 3100
Backup ContactNadia A Khan, MD MSc
nakhanubc@gmail.com604 682 2344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026