Table 2 Data Collection Measures
Outcome | Test | Measurement |
|---|---|---|
Primary Outcome Measures | HbA1c/Fasting Lipid Profile | Blood specimens will be obtained at baseline, 3-, 6- and 12-months visits. |
Secondary Outcome Measures | Laboratory Measurements | Blood specimens will be obtained at baseline and 12-months visits. |
| Â | Physical Activity | The seven-day physical activity recall (PAR) will be used to measure of physical activity [29, 30]. |
|  | Diet | Dietary intake will be assessed using the Block 1998 Food Frequency Questionnaire [31–36]. |
|  | Medication Adherence | The eCAP® electronic compliance monitor (Information Mediary Corporation, Ottawa, Canada) will serve as the primary measure of medication adherence for this study. |
| Â | Self-monitoring of Blood Glucose | Glucometer downloads will be used to assess self-monitoring adherence. |
| Â | Blood pressure measurements | Blood pressure readings will be obtained at baseline, 3-, 6- and 12-months by a trained RA using automated BP monitors (OMRON IntelliSenseâ„¢ HEM-907XL) with the patient seated comfortably for 5 minutes prior to the measurements. |
| Â | Resource Utilization & Cost | The perspective of cost will be that of the payer. Previously validated questions on resource utilization will be administered as part of the baseline, 3-, 6-, and 12-month assessments. |
| Â | Body Composition | The BOD POD Gold Standard (Life Measurement, Inc., Concord, CA) will serve as the primary measure of body composition for this study. |
| Â | Anthropometrics | Measurements of body fat including height, weight, BMI, waist circumference, waist-to-hip ratio, and skinfold thickness will be obtained at baseline, 3-, 6-, and 12-month visits. |