A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Obesity Clinical Trial

— SHAPE  

Official title:

A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084928
• Other study ID #: IRB00035893
• Secondary ID: 1R34DK081723-01A
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: September 24, 2013
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	percent body fat		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	body mass index		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	waist-to-hip ratio		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	fasting glucose		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	blood pressure		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	plasma lipids		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	self-reported physical activity		24 weeks (16 week intervention, 8 week maintenance)	No
Secondary	Percent of Total Calories from Fat		24 weeks (16 week intervention, 8 week maintenance)	No