A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Study Overview
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Brief Summary
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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.

Official Title
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A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Behavioral: Lifestyle Intervention Classes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm (Diet and Exercise)<br>The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period. | Behavioral: Lifestyle Intervention Classes<br>* The intervention will be based on the Diabetes Prevention Program but tailored to the needs of the community based on feedback gathered in focus groups. Classes will be group-based and will use a variety of teaching techniques and group-based work to teach participants about behavior change, diet, and physical activity. Participant will be required to attend one group exercise class per week based on traditional Indian dances and other culturally appropriate activities. In order to reach their weekly exercise goal of 150 minutes or more per week, participants will also be able to attend an additional group exercise class, an organized group walk, do a culturally-tailored work out video created by the study staff, and/or exercise on their own.<br>* Other names: South Asian Health and Prevention Education (SHAPE);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 24 weeks (16 week intervention, 8 week maintenance) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent body fat |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| body mass index |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| waist-to-hip ratio |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| fasting glucose |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| blood pressure |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| plasma lipids |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| self-reported physical activity |  | 24 weeks (16 week intervention, 8 week maintenance) | 
| Percent of Total Calories from Fat |  | 24 weeks (16 week intervention, 8 week maintenance) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, obesity, pre-diabetes, South Asian