A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

NCT ID: NCT01084928

Last Updated: 2013-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-07-31

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.

Conditions

Diabetes; Obesity

Keywords

diabetes; obesity; pre-diabetes; South Asian

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Arm (Diet and Exercise)

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

Group Type: EXPERIMENTAL

Lifestyle Intervention Classes

Intervention Type: BEHAVIORAL

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.

Interventions

Lifestyle Intervention Classes

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

South Asian Health and Prevention Education (SHAPE)

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Venkat Narayan

Hubert Professor of Global Health and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Venkat Narayan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1R34DK081723-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00035893

Identifier Type: -

Identifier Source: org_study_id