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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02266576

Enrollment

207

Registered

2014-10-17

Start date

2015-06-30

Completion date

2017-08-30

Last updated

2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Syndrome

Brief summary

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.

Interventions

BEHAVIORALStandard 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.

BEHAVIORALEnhanced 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Body Mass Index (BMI) Through Month 12	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.
Change From Baseline in the Quality of Life Short Form Survey (SF-12)	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

Measure	Time frame	Description
Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	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).
Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	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
Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	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.
Change From Baseline in Empowerment	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

Measure	Time frame	Description
Systolic Blood Pressure	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.
Diastolic Blood Pressure	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.
Fasting Blood Glucose	Baseline, 6 months and 12 months	Performed via fasting participant finger stick with Alere Cholestech LDX POS device.
Symptoms of Historical Trauma	Baseline, 6 months and 12 months	By patient report using a modified version of the Indigenous People's Survey
Waist Circumference	Baseline, 6 months and 12 months	In centimeters, measured by trained assessor using standard protocol
Lipid Bioassays	Baseline, 6 months and 12 months	LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	102
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.	105
Total	207

Baseline characteristics

Characteristic	Enhanced DPP	Standard DPP	Total
Age, Continuous	52.1 years STANDARD_DEVIATION 13.8	51.9 years STANDARD_DEVIATION 12.8	52.0 years STANDARD_DEVIATION 13.3
Body Mass Index (BMI) Men	39.5 kg/m^2 STANDARD_DEVIATION 7.8	35.5 kg/m^2 STANDARD_DEVIATION 4.7	37.5 kg/m^2 STANDARD_DEVIATION 6.6
Body Mass Index (BMI) Women	37.2 kg/m^2 STANDARD_DEVIATION 6.2	37.1 kg/m^2 STANDARD_DEVIATION 5.8	37.2 kg/m^2 STANDARD_DEVIATION 6
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants	56 Participants	112 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants	46 Participants	95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	105 Participants	102 Participants	207 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	0 Participants	0 Participants	0 Participants
Sex: Female, Male Female	83 Participants	80 Participants	163 Participants
Sex: Female, Male Male	22 Participants	22 Participants	44 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 102	0 / 105
other Total, other adverse events	0 / 102	0 / 105
serious Total, serious adverse events	0 / 102	0 / 105

Outcome results

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.

Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Baseline	37.0 kg/m^2
Standard DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Change from baseline to month 6	-.7 kg/m^2
Standard DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Change in baseline to month 12	-.5 kg/m^2
Enhanced DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Baseline	37.8 kg/m^2
Enhanced DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Change from baseline to month 6	-.3 kg/m^2
Enhanced DPP	Change From Baseline in Body Mass Index (BMI) Through Month 12	Change in baseline to month 12	-.3 kg/m^2

Comparison: Baseline vs month 6p-value: 0.04Regression, Linear

Comparison: Baseline vs month 12p-value: 0.02Regression, Linear

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.

Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-baseline	41.5 score on a scale
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-change from baseline at month 6	3.0 score on a scale
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-change from baseline at month 12	2.2 score on a scale
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-baseline	47.1 score on a scale
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-change from baseline at month 6	1.5 score on a scale
Standard DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-change from baseline at month 12	2 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-change from baseline at month 6	1.7 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-baseline	40.2 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-baseline	48 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-change from baseline at month 6	3.1 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Mental-change from baseline at month 12	.3 score on a scale
Enhanced DPP	Change From Baseline in the Quality of Life Short Form Survey (SF-12)	Physical-change from baseline at month 12	2.9 score on a scale

Comparison: Baseline vs month 6 in physical component scorep-value: 0.004Regression, Linear

Comparison: Baseline vs month 12 in physical component scorep-value: 0.01Regression, Linear

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.

Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in Empowerment	Change from baseline scenarios (month 6)	-2.3 score on a scale
Standard DPP	Change From Baseline in Empowerment	Change from baseline emotional empowerment (mo 6)	0.2 score on a scale
Standard DPP	Change From Baseline in Empowerment	Change from baseline emotional empowerment (mo12)	-0.3 score on a scale
Standard DPP	Change From Baseline in Empowerment	Scenarios (baseline)	59.9 score on a scale
Standard DPP	Change From Baseline in Empowerment	Change from baseline scenarios (month 12)	0.2 score on a scale
Standard DPP	Change From Baseline in Empowerment	Emotional empowerment (baseline)	46.2 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Change from baseline scenarios (month 12)	-2.1 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Emotional empowerment (baseline)	47.1 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Scenarios (baseline)	57.1 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Change from baseline emotional empowerment (mo 6)	-0.4 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Change from baseline scenarios (month 6)	-1.9 score on a scale
Enhanced DPP	Change From Baseline in Empowerment	Change from baseline emotional empowerment (mo12)	0.9 score on a scale

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).

Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (baseline)	22.6 score on a scale
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (month 6)	-.6 score on a scale
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (month 12)	0.4 score on a scale
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (month 6)	-4.6 score on a scale
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (month 12)	-4.6 score on a scale
Standard DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (baseline)	37.9 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (month 6)	-2.51 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (month 6)	.4 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (month 12)	-0.7 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (month 12)	-0.4 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Unhealthy (baseline)	35.4 score on a scale
Enhanced DPP	Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices	Healthy (baseline)	22.8 score on a scale

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. * 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

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Baseline	1389.1 MET minutes per week
Standard DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Change from baseline at month 6	-94.3 MET minutes per week
Standard DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Change from baseline at month 12	144.6 MET minutes per week
Enhanced DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Baseline	1541 MET minutes per week
Enhanced DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Change from baseline at month 6	-23.5 MET minutes per week
Enhanced DPP	Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week	Change from baseline at month 12	-241.6 MET minutes per week

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.

Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Population: 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.

Arm	Measure	Group	Value (MEAN)
Standard DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Baseline	13.9 score on a scale
Standard DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Change from baseline at month 6	-2.3 score on a scale
Standard DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Change from baseline at month 12	-1.2 score on a scale
Enhanced DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Baseline	12.2 score on a scale
Enhanced DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Change from baseline at month 6	0.04 score on a scale
Enhanced DPP	Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms	Change from baseline at month 12	-0.1 score on a scale

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.