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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:June 2015
End Date:April 2017
Contact:Randall S Stafford, MD, PhD
Email:rstafford@stanford.edu
Phone:650-724-2400

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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 Alaskan Native peoples within a primary care
setting.

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 Alaskan Native peoples within a primary care
setting. Diabetes is disproportionately prevalent among low-socioeconomic status and
racial/ethnic minority populations in the US. The high prevalence of psychosocial stressors
such as depression, discrimination, and exposure to trauma among these populations
contributes to the high prevalence of diabetes and interferes with successful completion of
lifestyle interventions. The investigators hypothesize that a DPP that directly addresses
these psychosocial stressors will be superior to the standard DPP in addressing this
disparity in diabetes.

Inclusion Criteria:

- Self-identified urban AIAN 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).
We found this trial at
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San Jose, California 95128
Phone: 408-924-3014
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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