A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians (SHAPE)

Emory University

Status: Completed

Conditions: Diabetes; Obesity

Treatments: Behavioral: Lifestyle Intervention Classes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01084928

1R34DK081723-01A1 (U.S. NIH Grant/Contract)

IRB00035893

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 1 patient group

Intervention Arm (Diet and Exercise)

Experimental group

Description:

The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period.

Treatment:

Behavioral: Lifestyle Intervention Classes