Diabetes Mellitus, Type 2NCT02266576

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

A study testing Standard DPP and Enhanced DPP in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Stanford University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance
What is being tested?: Standard DPP and Enhanced DPP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 2 sitesUnited States
Study dates: Jun 2015to 30 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Reduced HDL: <40mg/dL (men); <50mg/dL (women)
Blood pressure: >130/80 or current treatment with antihypertensives
Fasting glucose: >100mg/dL

Who cannot join

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;

Show all 11Show fewer

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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Timpany Center of San Jose State University
San Jose, California, 95128
Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Read the 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.

Conditions: Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance
Being tested: Standard DPP, Enhanced DPP
Medical subject headings: Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard DPPBehavioural
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.
Enhanced DPPBehavioural
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 groups in NCT02266576
Study group	Role	What they receive
Standard Diabetes Prevention Program (DPP)	Active comparator	Participants receive Standard DPP over the course of 20 weeks. Receives: Behavioral: Standard DPP
Enhanced DPP	Experimental	Participants receive Standard DPP plus Enhanced DPP over the course of 20 weeks. Receives: Behavioral: Standard DPP; Behavioral: Enhanced DPP

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Change through month 12, with assessments at baseline, 6 months, and 12 months

Secondary outcomes (4)

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).
Measured: 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.
- 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
Measured: 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.
Measured: 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.
Measured: Change through month 12, with assessments at baseline, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201530 Aug 2017

First posted17 Oct 2014 (estimated)
Study startJun 2015
Primary completion30 Aug 2017
Study completion30 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02266576
Sponsor's protocol ID: SU-30015
Other IDs: PCORI-PCORIAD-1306-02172
Status last verified: Aug 2025
First submitted: 13 Oct 2014
Last updated: 26 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 27381232
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.
PubMed 32000738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
ClinicalTrials.gov ID: NCT02266576
Acronym / sponsor ID: SU-30015
Conditions: Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: San Jose State University, Patient-Centered Outcomes Research Institute
Study start: Jun 2015 (actual)
Primary completion: 30 Aug 2017 (actual)
Study completion: 30 Aug 2017 (actual)
First posted: 17 Oct 2014 (estimated)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Diabetes Prevention Program (DPP)	Active comparator	Behavioral: Standard DPPParticipants receive Standard DPP over the course of 20 weeks.
Enhanced DPP	Experimental	Behavioral: Standard DPP, Behavioral: Enhanced DPPParticipants receive Standard DPP plus Enhanced DPP over the course of 20 weeks.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard DPPThe 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.	Behavioural	Enhanced DPP, Standard Diabetes Prevention Program (DPP)
Enhanced DPPEnhanced 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.	Behavioural	Enhanced DPP

Primary outcome

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.
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.

4 secondary outcomes

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
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
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
Change From Baseline in Empowerment
Time frame: Change through month 12, with assessments at baseline, 6 months, and 12 months

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Diabetes Prevention Program (DPP)	102	85
Enhanced DPP	105	90

Primary outcome: 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. Mean (95% Confidence Interval). Unit: kg/m^2

Measure	Standard DPP n = 101	Enhanced DPP n = 104
Baseline	37.0 (35.63 to 38.37)	37.8 (36.43 to 39.17)
Change from baseline to month 6	-.7 (-1 to -.4)	-.3 (-0.7 to -.02)
Change in baseline to month 12	-.5 (-1 to -.1)	-.3 (-.7 to .2)

Standard DPP vs Enhanced DPP: p = 0.04, Regression, Linear
Standard DPP vs Enhanced DPP: p = 0.02, Regression, Linear

Population analysed: 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.

Primary outcome: 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. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Standard DPP n = 101	Enhanced DPP n = 104
Physical-baseline	41.5 (38.95 to 44.05)	40.2 (37.65 to 42.75)
Physical-change from baseline at month 6	3.0 (.9 to 5.1)	3.1 (1 to 5.2)
Physical-change from baseline at month 12	2.2 (-.1 to 4.5)	2.9 (.7 to 5.2)
Mental-baseline	47.1 (44.75 to 49.45)	48 (45.65 to 50.35)
Mental-change from baseline at month 6	1.5 (-1.1 to 4.2)	1.7 (-1.0 to 4.3)
Mental-change from baseline at month 12	2 (-.7 to 4.7)	.3 (-2.4 to 3)

Standard DPP vs Enhanced DPP: p = 0.004, Regression, Linear
Standard DPP vs Enhanced DPP: p = 0.01, Regression, Linear

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard DPP	0 of 102 (0%)	0 of 102 (0%)	0 of 102
Enhanced DPP	0 of 105 (0%)	0 of 105 (0%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27381232Rosas 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.
Derived from this study: PubMed 32000738Rosas 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Randall S Stafford, MD, PhD principal investigator

Stanford University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard DPP and Enhanced DPP in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266576, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.