N/A
Completed N=207
A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
Source: ClinicalTrials.gov NCT02266576 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Change From Baseline in Body Mass Index (BMI) Through Month 12 — 37.0; 37.8; -.7; -.3 kg/m^2 — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Mass Index (BMI) Through Month 12 |
37.0; 37.8; -.7; -.3; -.5; -.3 | 0.04 sig |
| PRIMARY Change From Baseline in the Quality of Life Short Form Survey (SF-12) |
41.5; 40.2; 3.0; 3.1; 2.2; 2.9 | 0.004 sig |
| SECONDARY Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices |
22.6; 22.8; -.6; .4; 0.4; -0.4 | — |
| SECONDARY Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week |
1389.1; 1541; -94.3; -23.5; 144.6; -241.6 | — |
| SECONDARY Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms |
13.9; 12.2; -2.3; 0.04; -1.2; -0.1 | — |
| SECONDARY Change From Baseline in Empowerment |
46.2; 47.1; 0.2; -0.4; -0.3; 0.9 | — |
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
- Triglycerides: 150mg/dL or higher
- Reduced HDL: 130/80 or current treatment with antihypertensives
- 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).
Data sourced from ClinicalTrials.gov (NCT02266576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.