Clinical trial NCT02266576: A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Official title: A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome
Insulin Resistance
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: San Jose State University
name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-17
Enrollment: 207
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change From Baseline in Body Mass Index (BMI) Through Month 12
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
measure: Change From Baseline in the Quality of Life Short Form Survey (SF-12)
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
Secondary outcomes:
measure: Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
measure: Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
measure: Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
measure: Change in From Baseline in Empowerment
timeFrame: Change through month 12, with assessments at baseline, 6 months, and 12 months
Other outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline, 6 months and 12 months
measure: Diastolic Blood Pressure
timeFrame: Baseline, 6 months and 12 months
measure: Fasting Blood Glucose
timeFrame: Baseline, 6 months and 12 months
measure: Symptoms of Historical Trauma
timeFrame: Baseline, 6 months and 12 months
measure: Waist Circumference
timeFrame: Baseline, 6 months and 12 months
measure: Lipid Bioassays
timeFrame: Baseline, 6 months and 12 months
Locations:
city: San Jose
country: United States
facility: Timpany Center of San Jose State University
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Randall S Stafford, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.