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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-08-30

Brief Summary

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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 Alaska Native people within a primary care setting.

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Detailed Description

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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 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.

Conditions

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Diabetes Mellitus, Type 2 Metabolic Syndrome Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Diabetes Prevention Program (DPP)

Participants receive Standard DPP over the course of 20 weeks.

Group Type ACTIVE_COMPARATOR

Standard DPP

Intervention Type BEHAVIORAL

The Standard Diabetes Prevention Program (DPP) delivered by the San Jose State Timpany Center is the Group Lifestyle Balance™ DPP, which has previously been tailored for urban American Indians and Alaska Natives by the Indian Health Service. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.

Enhanced DPP

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

Group Type EXPERIMENTAL

Standard DPP

Intervention Type BEHAVIORAL

The Standard Diabetes Prevention Program (DPP) delivered by the San Jose State Timpany Center is the Group Lifestyle Balance™ DPP, which has previously been tailored for urban American Indians and Alaska Natives by the Indian Health Service. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.

Enhanced DPP

Intervention Type BEHAVIORAL

Enhanced DPP components consist of access to a mental health counselor, active referrals to mental health services, and traditional healing workshops such as the use of talking circles, a modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.

Interventions

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Standard DPP

The Standard Diabetes Prevention Program (DPP) delivered by the San Jose State Timpany Center is the Group Lifestyle Balance™ DPP, which has previously been tailored for urban American Indians and Alaska Natives by the Indian Health Service. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.

Intervention Type BEHAVIORAL

Enhanced DPP

Enhanced DPP components consist of access to a mental health counselor, active referrals to mental health services, and traditional healing workshops such as the use of talking circles, a modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes