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The purpose of this randomized, controlled study is to evaluate whether the knowledge of a personalized diabetes risk score affects adherence to a 12-week diet and exercise lifestyle change program in prediabetic patients. The intervention group will receive diabetes risk score results at the beginning of the twelve weeks, and the control group will not receive these results. Both groups will review their baseline and 12-week diabetes risk score results at the conclusion of the program and will be followed for an additional twelve weeks. Attendance rates and changes in weight, BMI, abdominal circumference, blood pressure, HgA1c, fasting blood glucose, cholesterol, and diabetes risk score will be compared between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - diabetes risk score | Active Comparator | the participants in the control group did not receive their diabetes risk score at the beginning of the trial, but did receive their scores to include baseline at the 12 and 24 week points. |
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| Intervention - diabetes risk score | Experimental | the subjects in the intervention arm received their diabetes risk scores at the beginning of the trial, 12 weeks and 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diabetic risk score | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance rates | Attendance rates (percentage of subjects attending the classes) of the two groups will be compared. | 6 months |
| Change in weight | change in weight from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Change in BMI | change in BMI from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Change in abdominal circumference | change in abdominal circumference from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | change in blood pressure from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Change in HgA1c | change in HgA1c from baseline to 12 weeks and 24 weeks will be compared between groups. |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of type 1 or type 2 diabetes mellitus (defined as FPG ≥126 mg/dl on two different occasions or random blood sugar ≥200) If fasting glucose >= 126 only once, a second lab does not need to be arranged in an attempt to diagnose diabetes. It is acceptable for the patient to proceed in the trial. Also, Tethys lab results (e.g., fasting glucose and A1C) should not be used to make decisions about including or excluding patients in the trial. Only Air Force lab results should be used to make this determination.
Discontinuation Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W True, MD | US Air Force | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant Medical Center | Travis AFB | California | 94535 | United States | ||
| Andrews Military Medical Center |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| baseline, 12 weeks, 24 weeks |
| Change in fasting blood glucose | change in fasting blood glucose from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Change in cholesterol | change in cholesterol from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, 24 weeks |
| Change in diabetes risk score | change in diabetes risk score from baseline to 12 weeks and 24 weeks will be compared between groups. | baseline, 12 weeks, and 24 weeks |
| Andrews Air Force Base |
| Maryland |
| 20762 |
| United States |
| Nellis Family Medicine | Nellis Air Force Base | Nevada | 89191 | United States |
| Wright Patterson Medical Center | Wright-Patterson AFB | Ohio | 45324 | United States |
| Wilford Hall Ambulatory Surgical Center | Lackland Air Force Base | Texas | 78236 | United States |