Status:
COMPLETED
Latinos Combating Diabetes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Pre Diabetes
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators plan to test two different strategies for weight loss and diabetes prevention in the Latino community in and around Forsyth County, North Carolina. The study is designed to test the ...
Detailed Description
Type 2 diabetes mellitus is a major health concern in the United States, accounting for 90 to 95% of the more than 25 million diagnosed cases of diabetes in 2010. Racial and ethnic minorities are disp...
Eligibility Criteria
Inclusion
- Men and women 18 years and older who reside in or near Forsyth County, North Carolina
- Self-identified as Hispanic or Latino
- Evidence of pre-diabetes: Hemoglobin A1c of 5.7-6.5%
- Body Mass Index (BMI): 25-45 kg/m2
- Potential participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison usual care condition
Exclusion
- Currently involved in a supervised program for weight loss
- Clinical history of diabetes or newly diagnosed diabetes at screening
- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.
- Uncontrolled high blood pressure (BP): BP \> 160/100. Potential participants can be re-screened after control has been achieved.
- Pregnancy, breast feeding, or planning pregnancy within 2 years
- Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
- Chronic use of medicine known to significantly affect glucose metabolism (e.g., corticosteroids, protease inhibitors)
- Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to La Comunidad, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with La Comunidad.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01831921
Start Date
January 1 2014
End Date
June 30 2017
Last Update
August 28 2019
Active Locations (1)
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1
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157