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Completed

NCT Number: NCT01084928

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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: South Asian Health and Prevention Education (SHAPE)

Primary outcomes

  1. body weight

    Time frame: 24 weeks (16 week intervention, 8 week maintenance)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Diabetes Association
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: SHAPE

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2010
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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