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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Behavioral: Standard DPP; Behavioral: Enhanced DPP

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Timpany Center of San Jose State University
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Diabetes Prevention Program (DPP); Participants receive Standard DPP over the course of 20 weeks.	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.
Experimental: Enhanced DPP; Participants receive Standard DPP plus Enhanced DPP over the course of 20 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	The FFQ modified to incorporate culturally-relevant food choices (e.g. corn tortillas and frybread) was used. Food items were scored on a scale of 1 to 6 (6 corresponding to the greatest frequency of consumption), and categorized as "healthy," "unhealthy," and "undetermined" based on classifications previously determined by Teuful-Shone et al. "Healthy" foods were those recommended for increased intake (e.g. green leafy salad). "Unhealthy" foods were recommended for decreased intake (e.g. soft drinks), and all remaining foods were "undetermined." Healthy and unhealthy food scores (but not undetermined) were collected for this outcome measure. Scores were summed for a total score. Healthy food choices (6 questions) score range 3-36 (higher scores mean healthier diet). Unhealthy food choices (13 questions) score range: 13-78 (lower scores mean healthier diet).	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	MET is a term used to represent the intensity of exercise. A MET is the ratio of the rate of energy expended during an activity to the rate of energy expended at rest. At least 1000 MET minutes per week are needed to lower the risk of disease.; 1 minute of light-intensity activities = 1.1 MET to 2.9 METs; 1 minute of moderate-intensity activities = 3.0 to 5.9 METs; 1 minute of vigorous-intensity activities = 6.0 METs or more	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	The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms.	Change through month 12, with assessments at baseline, 6 months, and 12 months
Change in From Baseline in Empowerment	The Growth and Empowerment Measure (GEM) was developed to measure change in dimensions of empowerment as defined and described by Aboriginal Australians who participated in the Family Well Being programme. The GEM has two components. The 14-item Emotional Empowerment Scale has a range of 12-60, with higher scores corresponding to more ability to feel and show the signs of empowerment . The 12-item Scenarios scale has a range of 12-84, with higher scores corresponding to better emotional empowerment in different scenarios.	Change through month 12, with assessments at baseline, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Blood pressure readings are expressed in millimeters of mercury. This unit is abbreviated as mm Hg. A normal reading would be any blood pressure below 120/80 mm Hg and above 90/60 mm Hg in an adult.	Baseline, 6 months and 12 months
Diastolic Blood Pressure	Blood pressure readings are expressed in millimeters of mercury (mmHg). A normal reading would be any blood pressure below 120/80 mm Hg and above 90/60 mm Hg in an adult.	Baseline, 6 months and 12 months
Fasting Blood Glucose	Performed via fasting participant finger stick with Alere Cholestech LDX POS device.	Baseline, 6 months and 12 months
Symptoms of Historical Trauma	By patient report using a modified version of the Indigenous People's Survey	Baseline, 6 months and 12 months
Waist Circumference	In centimeters, measured by trained assessor using standard protocol	Baseline, 6 months and 12 months
Lipid Bioassays	LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device	Baseline, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Patient-Centered Outcomes Research Institute; San Jose State University
• Investigators: Principal Investigator: Randall S Stafford, MD, PhD, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Growth and Empowerment Measure: Its Story and how can it assist in drug and alcohol settings?

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: SU-30015; PCORI-PCORIAD-1306-02172 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No