Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266576
Recruitment Status : Completed
First Posted : October 17, 2014
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
San Jose State University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Randall Stafford, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Metabolic Syndrome Insulin Resistance Behavioral: Standard DPP Behavioral: Enhanced DPP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : August 30, 2017

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.




Primary Outcome Measures :
  1. Change From Baseline in Body Mass Index (BMI) Through Month 12 [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]
    BMI is measured as weight in kg divided by the square of height in meters.

  2. Change From Baseline in the Quality of Life Short Form Survey (SF-12) [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]
    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).

  2. Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]

    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

  3. Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]
    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.

  4. Change in From Baseline in Empowerment [ Time Frame: Change through month 12, with assessments at baseline, 6 months, and 12 months ]
    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.


Other Outcome Measures:
  1. Systolic Blood Pressure [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  2. Diastolic Blood Pressure [ Time Frame: Baseline, 6 months and 12 months ]
    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.

  3. Fasting Blood Glucose [ Time Frame: Baseline, 6 months and 12 months ]
    Performed via fasting participant finger stick with Alere Cholestech LDX POS device.

  4. Symptoms of Historical Trauma [ Time Frame: Baseline, 6 months and 12 months ]
    By patient report using a modified version of the Indigenous People's Survey

  5. Waist Circumference [ Time Frame: Baseline, 6 months and 12 months ]
    In centimeters, measured by trained assessor using standard protocol

  6. Lipid Bioassays [ Time Frame: Baseline, 6 months and 12 months ]
    LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266576


Locations
Layout table for location information
United States, California
Timpany Center of San Jose State University
San Jose, California, United States, 95128
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
San Jose State University
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Randall S Stafford, MD, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Randall Stafford, Stanford University:
Study Protocol  [PDF] September 15, 2016
Statistical Analysis Plan  [PDF] October 9, 2019

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Randall Stafford, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02266576    
Other Study ID Numbers: SU-30015
PCORI-PCORIAD-1306-02172 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: October 17, 2014    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Metabolic Syndrome
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism