Clinical trial NCT01084928: A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
Official title: A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Keywords: diabetes
obesity
pre-diabetes
South Asian
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-03-11
Enrollment: 16
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. This study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the South Asian community. The outcomes of this project could be used to plan larger interventions to prevent diabetes in South Asians, a rapidly growing segment of the US population.


Eligibility criteria: Inclusion Criteria:

* Self-identified as being of South Asian origin
* Live in or near Atlanta, Georgia
* BMI greater than 22 kg/m2 calculated from standardized weight and height measurements (a BMI of greater than 22 kg/m2 is indicative of overweight in the South Asian population)
* A confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
* No prior diabetes diagnosis (physician diagnosis or on diabetes medication)
* A high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
* Fasting glucose of 100-125 mg/dL (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dL (impaired glucose tolerance), measured at baseline visit
* No history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant

Exclusion Criteria:

* Capillary glucose less than 120
* Fasting glucose less than 100 mg/dL or greater than 125 mg/dL OR 2 hour post-load glucose less than 140 mg/dL or greater than 199 mg/dL
* Age less than 25 years
* BMI less than 22 kg/m2
* Pregnancy
* History of heart disease or diabetes (other than gestational diabetes)
* Current functional difficulties
* Severe lung disease or cancer
* Failure to pass cardiovascular stress test

Primary outcomes:
measure: body weight
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
Secondary outcomes:
measure: percent body fat
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: body mass index
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: waist-to-hip ratio
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: fasting glucose
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: blood pressure
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: plasma lipids
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: self-reported physical activity
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
measure: Percent of Total Calories from Fat
timeFrame: 24 weeks (16 week intervention, 8 week maintenance)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Venkat Narayan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: