A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians

Trial ID or NCT#

NCT02266576

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - 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:
  1. - 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).
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Investigator(s)

Randall Stafford
Randall Stafford
Professor of Medicine (Stanford Center for Research in Disease Prevention)

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Contact

Randall S Stafford, MD, PhD
650-724-2400

View on ClinicalTrials.gov