A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Metabolic Syndrome, Insulin Resistance
Sponsor: Stanford University

A Patient-Centered Strategy For Improving 
Diabetes Prevention In Urban American 
Indians  
NCT02266576 
 
September 15, 2016 
Randall Stafford, MD, MPH, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
American Indians and Alaska Natives (AIAN) have disproportionate rates of obesity and 
diabetes and are more likely to suffer from psychosocial stressors than their white 
counterparts. These stressors increase obesity risks and are barriers to fully participating in 
lifestyle interventions. While lifestyle interventions such as the Diabetes Prevention Program 
have been effective among racial/ethnic groups, including American Indians, these 
interventions have not been studied in primary care or community-based settings and have 
not addressed barriers pertaining to psychosocial stressors or historical traumas. 
 
b. 
Objectives 
Our specific aims are: 
1. To deepen engagement of patient and provider stakeholders to better understand the patient-
centered perspective on psychosocial issues that influence progression to diabetes among 
urban AIANs. 
2. To refine, strengthen, and test an enhanced DPP that incorporates psychosocial support for 
urban AIANs in a RCT (n=204). 
3. To rapidly disseminate research findings to key stakeholders at the local state, and national 
level. These aims address the priority of eliminating health disparities by addressing the context 
of prevalent diabetes in a 
marginalized population. 
c. 
Rationale for Research in Humans 
Human subjects must be used to inform the development of a culturally appropriate and 
enhanced diabetes prevention program addressing psychosocial stressors and to evaluate the 
effectiveness of this program 
compared to the standard program. 
2. 
STUDY PROCEDURES 
a. 
Procedures 

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Phase 1, we will use the first six months of the study to refine and strengthen the intervention 
and study protocol by analyzing existing deidentified data from the Indian Health Center and 
using Talking Circles(TCs), Modified Photo Voice, and Digital Storytelling: 
 
1) We will analyze existing, deidentified pre- and post-intervention data from the existing IHC 
diabetes prevention program to identify information on the association between mental health, 
BMI, and other indicators. 
 
2) Talking Circles: A total of five Talking Circles (TCs) will be conducted with participants 50 
total participants) who are interested in urban AIAN health and wellness to gain relevant 
insights. Each talking circle will have up to 10 participants in the session and, in keeping with 
tradition, each session will have unlimited time. Skilled facilitators will lead participants in a 
process to set ground rules, share a meal, and participate in guided discussions. Participants 
will decide if the session will be audio recorded or if an alternative method to summarize the key 
points from the session will be used. 
 
3) Modified Photo Voice: Ten AIAN community members who participated in a TC will be invited 
to participate in a 6-week Modified Photo Voice project. Participants will participate in 6 sessions 
(one session per week) use a digital camera to take photographs and write photo narratives 
pertaining to health needs and assets in AIAN communities. During photo sharing sessions, 
participant discussions will be audio recorded and transcribed for data analysis to uncover 
relevant themes. Participants will share photos and findings with stakeholders during a 
Community Action Board (CAB) meeting so that the CAB can use these findings to develop 
appropriate interventions for the enhanced diabetes prevention program. 
 
4) Digital Storytelling: Ten AIAN community members who participated in a TC but did not 
participate in the Modified Photovoice project, will be invited to participate in a 3-day digital 
storytelling project. A skilled facilitator will guide participants through a process of storytelling 
combined with technology and digital media to create a 1-3 minute video. Open-ended 
interviews will be conducted with participants one week after video completion. These interviews 
will be audio recorded and transcribed to identify relevant themes. Participants will be invited to 
present their videos to the Community Action Board and discuss their experience with the 
process. 
 
In phase 2, we will conduct a randomized controlled trial with up to 210 participants for the 16 
week intervention. 
 
Recruited participants will be screened using a set of entry criteria, including a BMI between 30 
and 55, and one criterion for metabolic syndrome (e.g. triglycerides, HDL, blood pressure, 
fasting blood glucose). Patients cannot already have received a diagnosis of Type II diabetes 
(among other exclusionary criteria). Potentially eligible patients complete a written consent 
process which includes a thorough presentation of the study's purpose, procedures, and 
potential risks & benefits. 
 
1) Participants will be referred or self-referred to the study. 
2) Initial Screen (self-report): Conducted either in-person or by phone. 
3) Clinical Screen*: In-person verification of eligibility measurements (ie. Weight and lab 
measurements). *The clinical screen can be skipped if clinical values <3 months are available 
(ie. weight and lab measurements) 
4) Consent: Written, informed consent will be obtained 
 

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Participants will be recruited by Timpany Center staff and community members.  If they are 
otherwise eligible except that some of their information is more than 3 months old, we will 
conduct a clinical screening to collect recent blood pressure, and blood test for cholesterol and 
blood sugar. They will consent in- person for the clinical screening. Eligible participants will 
receive an explanation about the study and sign the full study consent form. After signing the 
consent form, the participant completes baseline data collection. This includes an interviewer 
administered questionnaire, a blood test, clinical measurements, and wearing a pedometer for 7 
days. After all baseline data is collected, the participant is randomly assigned to ONE of two 
groups: 1) diabetes prevention program (DPP) or 2) enhanced diabetes prevention program 
(DPP+). 
 
There are 102 people in the standard DPP and 102 people in the enhanced diabetes prevention 
program to address historical trauma (DPP+). Participants will complete 3 evaluations during 
the research study: baseline, 5 months (1 week following the conclusion of intervention), 
Participants enrolled in the last cohorts will not have as many follow-up evaluations as those 
enrolled in initial cohorts. The evaluations include blood draws, other measurements (blood 
pressure, height, weight, and waist circumference), and a series of questionnaires. Blood 
samples and other measurements will be collected at all of the evaluation visits (baseline, 5 
months, 8 months, 14 months, and 20 months) after a more than 8 hour fast. The volume of 
most blood samples will be 20 cc's (approximately 1.5 tablespoons). Any samples left over after 
analysis will be destroyed when the study is completed. Questionnaires include a series of 
questions about their eating patterns, physical activity habits, smoking status, past medical 
history, current medications, use of additional health care resources, resilience, and emotional 
status. Questionnaires will be filled out at the clinic visits at baseline, 5 months, 8 months, 14 
months, and 20 months. 
b. 
Procedure Risks 
We have designed this study to be least risky through the following means: 
1) The intervention targets improvement of behaviors (diet, exercise, stress reduction) that can 
help decrease weight; thereby, decreasing the chance of cardiovascular disease. 
2) The intervention recommendations are based on accepted clinical guidelines. 
3) The intervention builds on previous trials conducted by key investigators on this project. 
c. 
Use of Deception in the Study: 
Deception will not be used in the research study. 
d. 
Use of Audio and Video Recordings 
We may use audio recording or video recording for Talking Circles, Modified Photovoice, Digital 
Storytelling, CAB meetings, and intervention classes for research purposes to analyze 
transcribed data and for educational purposes in order to review how the health educators are 
presenting the protocol to the participants. We may also use audio recording for interviewing 
participants about how they feel about the health education they receive. 
 
We will also use camera pictures (and accompanying written or audio narrative) and video 
footage created by participants to share cultural stories, and perceptions of health needs and 
assets in the AIAN community. Audio recordings from interview debriefings will be destroyed 
once they have been transcribed. Photos, videos, and 
accompanying audio from Modified Photo Voice and Digital Storytelling maybe used for 
educational purposes, such as during community presentations or scientific meetings and 

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conferences. Photos, videos, and audio will not be linked to individuals unless we have received 
express written approval to use the media for a given purpose. 
e. 
Alternative Procedures or Courses of Treatment 
Standard treatments for weight management and diabetes prevention will be described to all 
participants. This program utilizes existing standards of care. No standard treatment is being 
withheld. The alternative is not to participate and to individually pursue an exercise program(s), 
work with a personal trainer, or consult with a dietitian on diet modifications. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
If funding allows, we will continue with the enhanced diabetes prevention program. However, 
the enhanced components of the program may not typically be covered by the Indian Health 
Center of Santa Clara Valley, so we do not guarantee it. 
g. 
Study Endpoint(s) 
Because our primary end point is increased resilience and weight loss for diabetes prevention, 
we do not expect any adverse events to cause us to terminate the study early. We plan to 
continue the study for the full 20 months and provide participants with the opportunity to 
participate in several follow-up focus groups to contextualize study results. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
AIANs are more than twice as likely to be diagnosed with diabetes compared to white 
Americans (8% vs. 18%). Additionally, compared to non- Hispanic whites, AIANs have high 
rates of depression symptoms (e.g., sadness some of the time 14% vs. 8%), any illicit drug use 
(18% vs. 9%), more than once binge drinking in the last month (32% vs. 17%), reported "not 
satisfied with life" (10% vs. 5%), 14+ days/month with poor mental health (18% vs. 11%), and 
serious psychological distress (5.2% vs. 3.1%). AIAN scholars have described the cumulative 
effects of the hardships AIANs have experienced over the centuries as historical and 
intergenerational trauma. Although diabetes and historical trauma have been researched 
separately, very little research exists on the conceptualization or measurement of trauma as it 
relates to metabolic outcomes. 
b. 
Findings from Past Animal Experiments 
NA 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
For Talking Circles: 
i. 10-15 
ii. 10-15 
iii. We will enroll talking circle participants based on the following criteria: 
a. self-identified AIAN 
 
For Modified Photovoice Project 
i. 10-15 

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ii. 10-15 
iii. We will enroll 10 AIAN community members who participated in the talking circles 
 
For the Digital Storytelling Project 
i. 10-15 
ii. 10-15 
iii. We will enroll 10 AIAN community members who participated in the talking circles but not the 
photovoice project 
 
For the Randomized Controlled Trial (RCT) 
i. Up to 210 
ii. Up to 210 
iii. We will enroll AIAN adults who have a BMI between 30 and 55 and at least 1 risk factor for 
metabolic syndrome as the ultimate goal of the study is to prevent diabetes in AIAN populations. 
b. 
Age, Gender, and Ethnic Background 
i. Older than 21 
ii. Men and Women 
iii. Self-identified as AIAN 
c. 
Vulnerable Populations 
We are working with an AIAN population that may include participants who are economically 
disadvantaged. The reason for working with these participants is because diabetes is 
disproportionately prevalent among low-socioeconomic status (SES) and racial/ethnic minority 
populations in the United States (US), which is why we are trying to improve health care for this 
population 
d. 
Rationale for Exclusion of Certain Populations 
The study is not including children because the focus of our research is diabetes prevention 
which has a low prevalence among children. Those children with the disease likely necessitate 
unique intervention strategies not present in our research. 
e. 
Stanford Populations 
NA 
f. 
Healthy Volunteers 
Up to 210 healthy volunteers may be included in the randomized controlled trial. The study aims 
to promote healthy lifestyles in people who are at increased risk for diabetes. Other than obesity 
and risk factors for diabetes, the participants should be generally healthy. The volunteers will 
not be exposed to any additional risks or harm. 
g. 
Recruitment Details 
Timpany Center staff will recruit participants from the center and surrounding community. They 
will advertise and recruit for the study at cultural events. Staff will: 1) utilize clinical records to 
identify patients who meet the eligibility criteria; 2) meet with clinical providers and ask them to 
refer potentially eligible patients; 3) attend numerous AIAN cultural events such as Pow Wows; 
4) reach out to public schools in San Jose with the highest concentration of AIAN children. 
 

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Talking Circles 
We will recruit 10-15 participants for 5 talking circles. We will recruit participants who have 
expressed an interest in the health of urban AIAN such as IHC staff, founding members and 
board members, as well as service users and illness survivors . 
 
Modified Photovoice 
We will recruit 10 AIAN community members who also participated in the talking circles. 
 
Digital Storytelling 
We will recruit 10 AIAN community members who participated in the talking circles but not the 
modified photovoice. 
 
Randomized Controlled Trial 
We will recruit up to 210 AIAN adults who have a BMI between 30 and 55 and at least 1 risk 
factor for metabolic syndrome. The study will be open to the general public. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Inclusion for Talking Circles 
i. Self-Identified AIAN 
ii. Experience with the historical psychosocial stressors faced by AIANs 
 
Inclusion for Modified Photovoice 
i. 10 participants from the talking circles 
 
Inclusion for Digital Storytelling 
i. 10 participants from the talking circle who did not participate in the modified photovoice 
 
Inclusion for Randomized Controlled Trial 
i. Self-identified urban AIAN men and women 
ii. BMI Between 30-55 
iii. Not diagnosed with Type II Diabetes 
iv. At least one of the following criteria 
 
a. Triglycerides: 150mg/dL or higher 
 
b. Reduced HDL: <40mg/dL (men); <50mg/dL (women) 
 
c. Blood pressure: >130/80 or current treatment with antihypertensives 
 
d. Fasting glucose: >100mg/dL 
ii. 
Exclusion Criteria 
Exclusion criteria for Randomized Controlled Trial 
i. Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, 
diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse; 
ii. On greater than 10 prescription medications. 
iii. Psychiatric disorders requiring atypical antipsychotics or multiple medications; 
iv. Inappropriate for moderate exercise according to the Revised Physical Activity Readiness 
Questionnaire; 
v. Pregnant, planning to become pregnant, or lactating; 
vi. Family household member already enrolled in the study; 
vii. Already enrolled or planning to enroll in a clinical trial that would limit full participation in the 

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study; 
viii. Resident of a long- term care facility; 
ix. Lack of spoken English by patient or a household member > 18 y who can serve as 
interpreter; 
x. Plans to move during the study period (9 months post-randomization); 
xi. Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, 
chronic pain). 
i. 
Screening Procedures 
Exclusion criteria for Randomized Controlled Trial 
i. Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, 
diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse; 
ii. On greater than 10 prescription medications. 
iii. Psychiatric disorders requiring atypical antipsychotics or multiple medications; 
iv. Inappropriate for moderate exercise according to the Revised Physical Activity Readiness 
Questionnaire; 
v. Pregnant, planning to become pregnant, or lactating; 
vi. Family household member already enrolled in the study; 
vii. Already enrolled or planning to enroll in a clinical trial that would limit full participation in the 
study; 
viii. Resident of a long-term care facility; 
ix. Lack of spoken English by patient or a household member > 18 y who can serve as 
interpreter; 
x. Plans to move during the study period (9 months post-randomization); 
xi. Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, 
chronic pain). 
j. 
Participation in Multiple Protocols 
Participants will be asked about participation in other studies during the screening process. If 
they are in another study, they will need to gain approval from both study protocol directors to 
remain in both studies. Additionally, they will be asked to inform study researchers if they join 
another study during the duration of their participation in this study. 
k. 
Payments to Participants 
Participants in the RCT will receive payment in form of incentives, such as running shoes and 
farmer’s market vouchers. Individuals will receive a gift card for $20 or equivalent incentive 
valued at $20 and a T-shirt valued at $10 upon completion of the assessment. To promote 
retention, participants who express that transportation is a barrier will be offered assistance with 
transportation in the form of bus passes or taxi rides, depending on their circumstances. 
l. 
Costs to Participants 
There will be no costs to the subjects for the diabetes prevention intervention. 
m. 
Planned Duration of the Study 
The intervention with be conducted over 20 weeks. We anticipate the screening of participants 
will take 1 hour. Active participation in the study will take a minimum of 2 hours a week for 
participation in group sessions and 1.5 hours for each evaluation. Participants may decide to 

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make healthy lifestyle changes, such as increasing their physical activity levels as a result of 
participating in the study. Finally, we anticipate analysis of participant data will take 3 months. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
NA 
ii. 
Investigational drugs 
NA 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
NA 
iv. 
Procedures 
NA 
v. 
Radioisotopes/radiation-producing machines 
NA 
vi. 
Physical well-being: 
Randomization to the usual diabetes prevention program (DPP) could improve physical well-
being while randomization to the enhanced DDP (DPP+) has greater potential to improve 
physical well-being. 
vii. 
Psychological well-being 
Randomization to the usual diabetes prevention program (DPP) could improve physical well-
being while randomization to the enhanced DDP (DPP+) has greater potential to improve 
psychological well-being. 
viii. 
Economic well-being 
Randomization to the usual diabetes prevention program (DPP) could improve economic well-
being while randomization to enhanced DDP could improve long-term economic well-being by 
reducing the chance of costly obesity-related illness. 
ix. 
Social well-being  
Randomization to the usual diabetes prevention program (DPP) could improve social well-being 
while randomization to enhanced DDP could also improve social well-being. However, 
randomization to both groups could also negatively affect social well-being if someone in the 
participant’s social circle reacts negatively to the participant trying to make healthy changes. 
x. 
Overall evaluation of risk 
Low - innocuous procedures such as phlebotomy, urine or stool collection, no therapeutic 
agent, or safe therapeutic agent such as the use of an FDA approved drug or device. 

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b. 
International Research Risk Procedures 
NA 
c. 
Procedures to Minimize Risk 
For Aims 1 and 2, participants will be made aware that they will be audio-taped and that these 
tapes will be analyzed without identifiable information. Participants will be allowed to discontinue 
participation at any time if they are uncomfortable. They can also elect to not participate in any 
portion of the study protocol. For the RCT, participants will be made aware of the study protocol 
through the informed consent process. The IHC DPP staff members and the Steering 
Committee will take time to discuss the meaning of participation, including the potential risks, 
and potential benefits. In addition, the research team will monitor all SAEs and follow 
appropriate reporting mechanisms. The study will also include a Data and Safety Monitoring 
Board (DSMB) to monitor and minimize risks to participants. This careful consent process, 
monitoring of SAEs, and oversight provided by the DSMB are the planned procedures for 
protecting against and minimizing all potential risks. 
d. 
Study Conclusion 
We will terminate the study if regular comparison analysis shows that the study poses harm to 
an intervention group. However, because the study is using behavioral change for weight-loss, 
the chance of termination is remote. In the event of adverse effects, we will have referrals to 
nurse practitioner as well as primary care physicians. 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review:  
Data Monitoring Board members: 
Board members include: 
-Veronica Yank, MD 
-Mike Baiocchi, PhD 
-Virgil Moorehead, PhD  
-Steve Adelsheim, MD  
ii. 
Frequency of DSMB meetings 
- DSMB meetings are schedule annually or on an ad hoc basis when needed. 
iii. 
Specific triggers or stopping rules 
                              -There were not triggers or stopping rules. 
iv. 
DSMB Reporting 
- Reporting: Hayley Hedlin, PhD 
v. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
                    N 
vi. 
Will a board, committee, or safety monitor be responsible for study 
monitoring? (Y/N) 
  Y 

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f. 
Risks to Special Populations 
               NA 
6. 
BENEFITS 
Subjects may experience the benefit of better health behavior and the Timpany Center may 
have improved ability to address the diabetes epidemic 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health 
Insurance Portability and Accountability Act (HIPAA) and privacy policies of Stanford 
University, Stanford Health Care, and Stanford Children’s Health.