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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01084928
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : September 25, 2013
Sponsor:
Collaborators:
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Venkat Narayan, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Obesity Behavioral: Lifestyle Intervention Classes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
Study Start Date : April 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012
Arms and Interventions
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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 Name: South Asian Health and Prevention Education (SHAPE)


Outcome Measures
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Primary Outcome Measures :
  1. body weight [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]

Secondary Outcome Measures :
  1. percent body fat [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  2. body mass index [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  3. waist-to-hip ratio [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  4. fasting glucose [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  5. blood pressure [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  6. plasma lipids [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  7. self-reported physical activity [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]
  8. Percent of Total Calories from Fat [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084928


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Venkat Narayan, MD, PhD Emory University
More Information
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Responsible Party: Venkat Narayan, Hubert Professor of Global Health and Epidemiology, Emory University
ClinicalTrials.gov Identifier: NCT01084928    
Other Study ID Numbers: IRB00035893
1R34DK081723-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013
Keywords provided by Venkat Narayan, Emory University:
diabetes
obesity
pre-diabetes
South Asian
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases