Healthy Living Partnership to Prevent Diabetes
Completed · Not applicable
Conditions studied: Prediabetes, Obesity
In brief
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 program in reducing blood glucose in people at risk for developing diabetes mellitus.
Key facts
- Study ID
- NCT00631345
- Run by
- Wake Forest University Health Sciences
- People needed
- 301
- Starts
- 2007-08-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2020-02-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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