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A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Not Recruiting
Trial ID: NCT02266576
Purpose
The goal of the proposed research 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
Stanford Investigator(s)
Randall Stafford
Professor of Medicine (Stanford Center for Research in Disease Prevention)
Eligibility
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).
Intervention(s):
behavioral: Standard DPP
behavioral: Enhanced DPP
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Randall S Stafford, MD, PhD
650-724-2400