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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-PCORIAD-1306-02172 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| San Jose State University | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Diabetes Prevention Program (DPP) | Active Comparator | Participants receive Standard DPP over the course of 20 weeks. |
|
| Enhanced DPP | Experimental | Participants receive Standard DPP plus Enhanced DPP over the course of 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard DPP | Behavioral | The Standard Diabetes Prevention Program (DPP) delivered by the San Jose State Timpany Center is the Group Lifestyle Balanceâ„¢ 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. |
| 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 |
| 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). |
| 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 |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall S Stafford, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Timpany Center of San Jose State University | San Jose | California | 95128 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27381232 | Background | 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. | |
| 32000738 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Diabetes Prevention Program (DPP) | Participants receive Standard DPP (Group Lifestyle Balanceâ„¢ DPP delivered by the San Jose State Timpany Center) over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym. |
| FG001 | Enhanced DPP | Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard DPP | Participants receive Standard DPP over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym. |
| BG001 | Enhanced DPP |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | kg/m^2 | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard DPP | Participants receive Standard DPP over the course of 20 weeks. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan J. Vasquez | Stanford University | 408-858-4457 | jan.vasquez@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2016 | Oct 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2019 | Oct 9, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
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|
| 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. |
|
| 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.
| 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 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 |
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 |
| Stanford |
| California |
| 94305 |
| United States |
| Derived |
| 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. |
Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
|
|
|
| Primary | 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. | One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
|
|
|
| Secondary | 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). | One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
|
|
| Secondary | 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.
| One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | MET minutes per week | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
|
|
| Secondary | 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. | One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
|
|
| Secondary | Change 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. | One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis. | Posted | Mean | 95% Confidence Interval | score on a scale | Change through month 12, with assessments at baseline, 6 months, and 12 months |
|
|
|
| Other Pre-specified | 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. | Not Posted | Baseline, 6 months and 12 months | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, 6 months and 12 months | Participants |
| Other Pre-specified | Fasting Blood Glucose | Performed via fasting participant finger stick with Alere Cholestech LDX POS device. | Not Posted | Baseline, 6 months and 12 months | Participants |
| Other Pre-specified | Symptoms of Historical Trauma | By patient report using a modified version of the Indigenous People's Survey | Not Posted | Baseline, 6 months and 12 months | Participants |
| Other Pre-specified | Waist Circumference | In centimeters, measured by trained assessor using standard protocol | Not Posted | Baseline, 6 months and 12 months | Participants |
| Other Pre-specified | Lipid Bioassays | LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device | Not Posted | Baseline, 6 months and 12 months | Participants |
| 0 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | Enhanced DPP | Participants receive Enhanced DPP over the course of 20 weeks. Enhanced DPP components consist of Standard DPP components, plus access to a mental health counselor, active referrals to mental health services, and traditional healing workshops, such as the use of talking circles, and modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief. | 0 | 105 | 0 | 105 | 0 | 105 |
Upon approval of community advisory board.
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| Physical-change from baseline at month 6 |
|
|
| Physical-change from baseline at month 12 |
|
|
| Mental-baseline |
|
|
| Mental-change from baseline at month 6 |
|
|
| Mental-change from baseline at month 12 |
|
|
Baseline vs month 12 in physical component score
| Regression, Linear |
The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender. |
| 0.01 |
| Other |
| Healthy (month 6) |
|
|
| Healthy (month 12) |
|
|
| Unhealthy (baseline) |
|
|
| Unhealthy (month 6) |
|
|
| Unhealthy (month 12) |
|
|
| Change from baseline at month 6 |
|
|
| Change from baseline at month 12 |
|
|
| Change from baseline at month 6 |
|
|
| Change from baseline at month 12 |
|
|
| Change from baseline emotional empowerment (mo 6) |
|
|
| Change from baseline emotional empowerment (mo12) |
|
|
| Scenarios (baseline) |
|
|
| Change from baseline scenarios (month 6) |
|
|
| Change from baseline scenarios (month 12) |
|
|