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A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01084928
Acronym
SHAPE
Enrollment
16
Registered
2010-03-11
Start date
2010-04-30
Completion date
2012-07-31
Last updated
2013-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

Keywords

diabetes, obesity, pre-diabetes, South Asian

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.

Interventions

BEHAVIORALLifestyle 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.

Sponsors

American Diabetes Association
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
body weight24 weeks (16 week intervention, 8 week maintenance)

Secondary

MeasureTime frame
body mass index24 weeks (16 week intervention, 8 week maintenance)
waist-to-hip ratio24 weeks (16 week intervention, 8 week maintenance)
fasting glucose24 weeks (16 week intervention, 8 week maintenance)
percent body fat24 weeks (16 week intervention, 8 week maintenance)
plasma lipids24 weeks (16 week intervention, 8 week maintenance)
self-reported physical activity24 weeks (16 week intervention, 8 week maintenance)
Percent of Total Calories from Fat24 weeks (16 week intervention, 8 week maintenance)
blood pressure24 weeks (16 week intervention, 8 week maintenance)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026