Status:
COMPLETED
Healthy Living Partnership to Prevent Diabetes
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Prediabetes
Obesity
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention ...
Detailed Description
Social forces have promoted adverse behavioral patterns with respect to physical activity and nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2 diabetes mellit...
Eligibility Criteria
Inclusion
- Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
- BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
- Fasting blood glucose 95-125 mg/dl (inclusive)
- Willingness to Accept Randomization
Exclusion
- Currently involved in a supervised program for weight loss
- Clinical history of DM, or newly diagnosed DM at screening
- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
- Uncontrolled high blood pressure: BP \> 160/100
- 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
- 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 HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00631345
Start Date
August 1 2007
End Date
May 1 2015
Last Update
February 5 2020
Active Locations (1)
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1
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157