A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Trial ID or NCT#
NCT02266576
Status
NOT RECRUITING
Purpose
The goal of the proposed ÌÇÐÄ´«Ã½ is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaska Native people within a primary care setting.
Official Title
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Eligibility Criteria
Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * Urban of Indigenous Ancestry from the Americas (North, Central and South America)* Men and women* BMI Between 30-55* Not diagnosed with Type II Diabetes* At least one of the following criterion
- 1. Triglycerides: 150mg/dL or higher 2. Reduced HDL: \<40mg/dL (men); \<50mg/dL (women) 3. Blood pressure: \>130/80 or current treatment with antihypertensives 4. Fasting glucose: \>100mg/dL
Exclusion Criteria:
- * Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;* On greater than 10 prescription medications.* Psychiatric disorders requiring atypical antipsychotics or multiple medications;* Inappropriate for moderate exercise according to the Revised Physical Activity Readiness Questionnaire;* Pregnant, planning to become pregnant, or lactating;* Family household member already enrolled in the study;* Already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;* Resident of a long term care facility;* Lack of spoken English by patient or a household member \> 18 y who can serve as interpreter;* Plans to move during the study period (9 months post-randomization);* Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
Investigator(s)
Randall Stafford
Professor of Medicine (Stanford Prevention Research Center)
Contact us to find out if this trial is right for you.
Contact
Randall S Stafford, MD, PhD
650-724-2400
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