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

NCT02266576 | Completed Results DMC

• 2 other identifiers: SU-30015PCORI-PCORIAD-1306-02172
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Body Mass Index (BMI) Through Month 12

  BMI is measured as weight in kg divided by the square of height in meters.

  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)

  SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey to evaluate overall health-related quality of life. Answers are combined, scored and weighted into mental and physical functioning component scales. The scores for each scale range from 0 to 100. A higher value indicates a better quality of life of the patient.

  Change through month 12, with assessments at baseline, 6 months, and 12 months

Secondary Outcomes (4)

• 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 From Baseline in Empowerment

  Change through month 12, with assessments at baseline, 6 months, and 12 months

Other Outcomes (6)

• Systolic Blood Pressure

  Baseline, 6 months and 12 months

• Diastolic Blood Pressure

  Baseline, 6 months and 12 months

• Fasting Blood Glucose

  Baseline, 6 months and 12 months

Study Arms (2)

Standard Diabetes Prevention Program (DPP)

ACTIVE COMPARATOR

Participants receive Standard DPP over the course of 20 weeks.

Behavioral: Standard DPP

Enhanced DPP

EXPERIMENTAL

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

Behavioral: Standard DPP; Behavioral: Enhanced DPP

Interventions

Standard DPP 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; Standard Diabetes Prevention Program (DPP)

Enhanced DPP 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.

Enhanced DPP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Triglycerides: 150mg/dL or higher
• Reduced HDL: \<40mg/dL (men); \<50mg/dL (women)
• Blood pressure: \>130/80 or current treatment with antihypertensives
• Fasting glucose: \>100mg/dL

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• San Jose State University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Timpany Center of San Jose State University

San Jose, California, 95128, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• Rosas LG, Vasquez JJ, Naderi R, Jeffery N, Hedlin H, Qin F, LaFromboise T, Megginson N, Pasqua C, Flores O, McClinton-Brown R, Evans J, Stafford RS. Development and evaluation of an enhanced diabetes prevention program with psychosocial support for urban American Indians and Alaska natives: A randomized controlled trial. Contemp Clin Trials. 2016 Sep;50:28-36. doi: 10.1016/j.cct.2016.06.015. Epub 2016 Jul 2.

  PMID: 27381232 BACKGROUND

• Rosas LG, Vasquez JJ, Hedlin HK, Qin FF, Lv N, Xiao L, Kendrick A, Atencio D, Stafford RS. Comparing enhanced versus standard Diabetes Prevention Program among indigenous adults in an urban setting: a randomized controlled trial. BMC Public Health. 2020 Jan 30;20(1):139. doi: 10.1186/s12889-020-8250-7.

  PMID: 32000738 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Jan J. Vasquez
• Organization: Stanford University

jan.vasquez@stanford.edu

408-858-4457

Study Officials

• Randall S Stafford, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 17, 2014
• Study Start: June 1, 2015
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: August 26, 2025
• Results First Posted: January 2, 2020

Record last verified: 2025-08

Locations

US (2)