A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Not Applicable

Completed

• Conditions: Diabetes; Obesity
• Interventions: Behavioral: Lifestyle Intervention Classes

• Registration Number: NCT01084928
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-11
• Study Start: 2010-04
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm (Diet and Exercise)	Lifestyle Intervention Classes	The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period.

Primary Outcome Measures

Name	Time	Method
body weight	24 weeks (16 week intervention, 8 week maintenance)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States