NCT Number: NCT02266576
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Timpany Center of San Jose State University, San Jose, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months
Performed via fasting participant finger stick with Alere Cholestech LDX POS device.
Time frame: Baseline, 6 months and 12 months
By patient report using a modified version of the Indigenous People's Survey
Time frame: Baseline, 6 months and 12 months
In centimeters, measured by trained assessor using standard protocol
Time frame: Baseline, 6 months and 12 months
LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device
Stanford University
Other
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