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

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Information provided by (Responsible Party):
Venkat Narayan, Emory University
ClinicalTrials.gov Identifier:
NCT01084928
First received: March 1, 2010
Last updated: September 24, 2013
Last verified: September 2013

March 1, 2010
September 24, 2013
April 2010
July 2012   (final data collection date for primary outcome measure)
body weight [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
body weight [ Time Frame: 32 weeks (12 week intervention, 8 week maintenance, 12 week follow-up) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01084928 on ClinicalTrials.gov Archive Site
  • percent body fat [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • waist-to-hip ratio [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • plasma lipids [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • self-reported physical activity [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • Percent of Total Calories from Fat [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]
  • percent body fat [ Time Frame: 32 weeks (12 week intervention, 8 week maintenance, 12 week follow-up) ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • waist-to-hip ratio [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • fasting glucose [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • plasma lipids [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • self-reported physical activity [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Percent of Total Calories from Fat [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Diabetes
  • Obesity
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)
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.
Intervention: Behavioral: Lifestyle Intervention Classes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01084928
IRB00035893, 1R34DK081723-01A1
Yes
Venkat Narayan, Emory University
Emory University
  • American Diabetes Association
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Venkat Narayan, MD, PhD Emory University
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP