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
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