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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