Recruiting

NaMaSTe-Diabetes

Sponsor:

University of British Columbia

Code:

NCT02136654

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Culturally tailored diabetes program

Study Details

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.

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT02136654

Start date

Jul, 2015

Status verified date

Nov, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Culturally tailored diabetes program

Culturally tailored diabetes program

  • culturally tailored diabetes education
  • lifestyle counselling
  • medication adherence counseling
  • peer supporter
  • communication training
  • family member involvement

no intervention: Usual Care

Usual Care includes continuing to visit primary care physician for ongoing diabetes management Printed diabetes education materials.

Interventions

Culturally tailored diabetes program

Includes family member and peer support Includes communication training

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 ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Gurpreet Oshan, BA

778 387 3100

Nadia Khan, MD

nakhanubc@gmail.com

Principal Investigator:

Nadia Khan, MD

More Information

Sponsor

University of British Columbia

Last update posted

Nov 27, 2020

Last verified

Nov, 2020

Keywords

  • diabetes
  • ethnicity
  • South Asian
  • diabetes management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2020-11-27.