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
  Purpose

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 Intervention
Diabetes
Obesity
Behavioral: Lifestyle Intervention Classes

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • body weight [ Time Frame: 24 weeks (16 week intervention, 8 week maintenance) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084928

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
American Diabetes Association
Investigators
Principal Investigator: Venkat Narayan, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Venkat Narayan, Hubert Professor of Global Health and Epidemiology, Emory University
ClinicalTrials.gov Identifier: NCT01084928     History of Changes
Other Study ID Numbers: IRB00035893, 1R34DK081723-01A1
Study First Received: March 1, 2010
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
diabetes
obesity
pre-diabetes
South Asian

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014