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

NCT02266576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2025-08-26

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • San Jose State University

    collaborator OTHER

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Randall S Stafford, MD, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266576 on ClinicalTrials.gov