A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

NCT01084928 | Completed DMC

• 2 other identifiers: IRB000358931R34DK081723-01A1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• body weight

  24 weeks (16 week intervention, 8 week maintenance)

Secondary Outcomes (8)

• 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)

Study Arms (1)

Intervention Arm (Diet and Exercise)

EXPERIMENTAL

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

Behavioral: Lifestyle Intervention Classes

Interventions

Lifestyle Intervention Classes 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.

Also known as: South Asian Health and Prevention Education (SHAPE)

Intervention Arm (Diet and Exercise)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• American Diabetes Association: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia

Study Officials

• Venkat Narayan, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hubert Professor of Global Health and Epidemiology

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 11, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 25, 2013

Record last verified: 2013-09

Locations

US (1)