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

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

Sponsors

Lead Sponsor: Stanford University

Collaborator: San Jose State University
Patient-Centered Outcomes Research Institute

Source Stanford University
Brief Summary

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.

Detailed 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.

Overall Status Completed
Start Date June 2015
Completion Date August 30, 2017
Primary Completion Date August 30, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Body Mass Index (BMI) Through Month 12 Change through month 12, with assessments at baseline, 6 months, and 12 months
Change From Baseline in the Quality of Life Short Form Survey (SF-12) Change through month 12, with assessments at baseline, 6 months, and 12 months
Secondary Outcome
Measure Time Frame
Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices Change through month 12, with assessments at baseline, 6 months, and 12 months
Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week Change through month 12, with assessments at baseline, 6 months, and 12 months
Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms Change through month 12, with assessments at baseline, 6 months, and 12 months
Change in From Baseline in Empowerment Change through month 12, with assessments at baseline, 6 months, and 12 months
Enrollment 207
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Standard DPP

Description: 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

Intervention Name: Enhanced DPP

Description: 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.

Arm Group Label: Enhanced DPP

Eligibility

Criteria:

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).

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Randall S Stafford, MD, PhD Principal Investigator Stanford University
Location
Facility:
Timpany Center of San Jose State University | San Jose, California, 95128, United States
Stanford University School of Medicine | Stanford, California, 94305, United States
Location Countries

United States

Verification Date

December 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Randall Stafford

Investigator Title: Professor of Medicine

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard Diabetes Prevention Program (DPP)

Type: Active Comparator

Description: Participants receive Standard DPP over the course of 20 weeks.

Label: Enhanced DPP

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov