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

Stanford University

Status: Completed

Conditions: Insulin Resistance; Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Behavioral: Standard DPP; Behavioral: Enhanced DPP

Study type: Interventional

Funder types: Other

Identifiers

NCT02266576

SU-30015

PCORI-PCORIAD-1306-02172 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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 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.

Enrollment: 207 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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207 participants in 2 patient groups

Standard Diabetes Prevention Program (DPP)

Active Comparator group

Description:

Participants receive Standard DPP over the course of 20 weeks.

Treatment:

Behavioral: Standard DPP

Enhanced DPP

Experimental group

Description:

Participants receive Standard DPP plus Enhanced DPP over the course of 20 weeks.

Treatment:

Behavioral: Enhanced DPP

Behavioral: Standard DPP