Trial Outcomes & Findings for A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians (NCT NCT02266576)

NCT ID: NCT02266576

Last Updated: 2025-08-26

Results Overview

BMI is measured as weight in kg divided by the square of height in meters.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 207 participants
• Primary outcome timeframe: Change through month 12, with assessments at baseline, 6 months, and 12 months
• Results posted on: 2025-08-26

Participant Flow

Participant milestones

Measure	Standard Diabetes Prevention Program (DPP) Participants receive Standard DPP (Group Lifestyle Balance™ 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.	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.
Overall Study STARTED	102	105
Overall Study COMPLETED	85	90
Overall Study NOT COMPLETED	17	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard DPP n=102 Participants 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.	Enhanced DPP n=105 Participants 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.	Total n=207 Participants Total of all reporting groups
Age, Continuous	51.9 years STANDARD_DEVIATION 12.8 • n=5 Participants	52.1 years STANDARD_DEVIATION 13.8 • n=7 Participants	52.0 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	83 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=5 Participants	56 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	49 Participants n=7 Participants	95 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	102 Participants n=5 Participants	105 Participants n=7 Participants	207 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI) Men	35.5 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	39.5 kg/m^2 STANDARD_DEVIATION 7.8 • n=7 Participants	37.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants
Body Mass Index (BMI) Women	37.1 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants	37.2 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	37.2 kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

BMI is measured as weight in kg divided by the square of height in meters.

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
Change From Baseline in Body Mass Index (BMI) Through Month 12 Baseline	37.8 kg/m^2 Interval 36.43 to 39.17	37.0 kg/m^2 Interval 35.63 to 38.37
Change From Baseline in Body Mass Index (BMI) Through Month 12 Change from baseline to month 6	-.3 kg/m^2 Interval -0.7 to -0.02	-.7 kg/m^2 Interval -1.0 to -0.4
Change From Baseline in Body Mass Index (BMI) Through Month 12 Change in baseline to month 12	-.3 kg/m^2 Interval -0.7 to 0.2	-.5 kg/m^2 Interval -1.0 to -0.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
Change From Baseline in the Quality of Life Short Form Survey (SF-12) Physical-baseline	40.2 score on a scale Interval 37.65 to 42.75	41.5 score on a scale Interval 38.95 to 44.05
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 Interval 1.0 to 5.2	3.0 score on a scale Interval 0.9 to 5.1
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 Interval 0.7 to 5.2	2.2 score on a scale Interval -0.1 to 4.5
Change From Baseline in the Quality of Life Short Form Survey (SF-12) Mental-baseline	48 score on a scale Interval 45.65 to 50.35	47.1 score on a scale Interval 44.75 to 49.45
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 Interval -1.0 to 4.3	1.5 score on a scale Interval -1.1 to 4.2
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 Interval -2.4 to 3.0	2 score on a scale Interval -0.7 to 4.7

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
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 Interval 21.82 to 23.78	22.6 score on a scale Interval 21.62 to 23.58
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 Interval -0.7 to 1.5	-.6 score on a scale Interval -1.7 to 0.5
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 Interval -1.6 to 0.9	0.4 score on a scale Interval -0.9 to 1.7
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 Interval 33.44 to 37.36	37.9 score on a scale Interval 35.94 to 39.86
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 Interval -4.4 to -0.6	-4.6 score on a scale Interval -6.5 to -2.8
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 Interval -2.9 to 1.4	-4.6 score on a scale Interval -6.8 to -2.5

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week Baseline	1541 MET minutes per week Interval 1246.01 to 1835.19	1389.1 MET minutes per week Interval 1095.69 to 1682.51
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 Interval -314.8 to 267.8	-94.3 MET minutes per week Interval -386.2 to 197.6
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 Interval -591.9 to 108.7	144.6 MET minutes per week Interval -207.6 to 496.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
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 Interval 10.04 to 14.36	13.9 score on a scale Interval 11.55 to 16.25
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 Interval -2.2 to 2.3	-2.3 score on a scale Interval -4.6 to -0.1
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 Interval -2.7 to 2.6	-1.2 score on a scale Interval -3.8 to 1.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Enhanced DPP n=104 Participants 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.	Standard DPP n=101 Participants 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.
Change From Baseline in Empowerment Emotional empowerment (baseline)	47.1 score on a scale Interval 44.94 to 49.26	46.2 score on a scale Interval 44.04 to 48.36
Change From Baseline in Empowerment Change from baseline emotional empowerment (mo 6)	-0.4 score on a scale Interval -2.7 to 1.9	0.2 score on a scale Interval -2.0 to 2.5
Change From Baseline in Empowerment Change from baseline emotional empowerment (mo12)	0.9 score on a scale Interval -1.5 to 3.2	-0.3 score on a scale Interval -2.7 to 2.0
Change From Baseline in Empowerment Scenarios (baseline)	57.1 score on a scale Interval 53.77 to 60.43	59.9 score on a scale Interval 56.37 to 63.43
Change From Baseline in Empowerment Change from baseline scenarios (month 6)	-1.9 score on a scale Interval -5.1 to 1.3	-2.3 score on a scale Interval -5.6 to 1.0
Change From Baseline in Empowerment Change from baseline scenarios (month 12)	-2.1 score on a scale Interval -5.3 to 1.2	0.2 score on a scale Interval -3.1 to 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months and 12 months

Performed via fasting participant finger stick with Alere Cholestech LDX POS device.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months and 12 months

By patient report using a modified version of the Indigenous People's Survey

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months and 12 months

In centimeters, measured by trained assessor using standard protocol

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 months and 12 months

LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device

Outcome measures

Outcome data not reported

Adverse Events

Standard DPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced DPP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jan J. Vasquez

Stanford University

Phone: 408-858-4457

Email: jan.vasquez@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee Upon approval of community advisory board.
• Publication restrictions are in place

Restriction type: OTHER