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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: Behavioral: Lifestyle Intervention Classes

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm (Diet and Exercise); The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period.

Behavioral: 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.; Other Names: South Asian Health and Prevention Education (SHAPE)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Diabetes Association
• Investigators: Principal Investigator: Venkat Narayan, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 1, 2010
• First Submitted That Met QC Criteria: March 9, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 25, 2013
• Last Update Submitted That Met QC Criteria: September 24, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: diabetes; obesity; pre-diabetes; South Asian
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: IRB00035893; 1R34DK081723-01A1 (U.S. NIH Grant/Contract)