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

• 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: Stanford University
• Collaborators: San Jose State University; Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Randall Stafford, Stanford University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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).

Contacts and Locations

Locations

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

• 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

More Information

Additional Information:

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Results First Posted: January 2, 2020
• Last Update Posted: January 2, 2020
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism