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

Primary Purpose

Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard DPP
Enhanced DPP
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Timpany Center of San Jose State University
  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Diabetes Prevention Program (DPP)

Enhanced DPP

Arm Description

Participants receive Standard DPP over the course of 20 weeks.

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

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
October 13, 2014
Last Updated
December 9, 2019
Sponsor
Stanford University
Collaborators
San Jose State University, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02266576
Brief Title
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Official Title
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
San Jose State University, Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Diabetes Prevention Program (DPP)
Arm Type
Active Comparator
Arm Description
Participants receive Standard DPP over the course of 20 weeks.
Arm Title
Enhanced DPP
Arm Type
Experimental
Arm Description
Participants receive Standard DPP plus Enhanced DPP over the course of 20 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Standard DPP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced DPP
Intervention Description
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 Measure Information:
Title
Change From Baseline in Body Mass Index (BMI) Through Month 12
Description
BMI is measured as weight in kg divided by the square of height in meters.
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Title
Change From Baseline in the Quality of Life Short Form Survey (SF-12)
Description
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.
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices
Description
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).
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Title
Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week
Description
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
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Title
Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms
Description
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.
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Title
Change in From Baseline in Empowerment
Description
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.
Time Frame
Change through month 12, with assessments at baseline, 6 months, and 12 months
Other Pre-specified Outcome Measures:
Title
Systolic Blood Pressure
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Diastolic Blood Pressure
Description
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.
Time Frame
Baseline, 6 months and 12 months
Title
Fasting Blood Glucose
Description
Performed via fasting participant finger stick with Alere Cholestech LDX POS device.
Time Frame
Baseline, 6 months and 12 months
Title
Symptoms of Historical Trauma
Description
By patient report using a modified version of the Indigenous People's Survey
Time Frame
Baseline, 6 months and 12 months
Title
Waist Circumference
Description
In centimeters, measured by trained assessor using standard protocol
Time Frame
Baseline, 6 months and 12 months
Title
Lipid Bioassays
Description
LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device
Time Frame
Baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall S Stafford, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Timpany Center of San Jose State University
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27381232
Citation
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.
Results Reference
background
PubMed Identifier
32000738
Citation
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.
Results Reference
derived
Links:
URL
https://insight-prod.s3.ap-southeast-2.amazonaws.com/public/uploads/20171018.pdf
Description
Growth and Empowerment Measure: Its Story and how can it assist in drug and alcohol settings?

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

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