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| ID | Type | Description | Link |
|---|---|---|---|
| NYSDOH Contract# C021750 | |||
| Onondaga Cty,NY Contract#39407 |
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| Name | Class |
|---|---|
| County of Onondaga, NYS | UNKNOWN |
| NYS Department of Health | UNKNOWN |
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This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, 1 | Experimental | Intervention: Immediate 3 month program |
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| A, 2 | No Intervention | Wait-List Control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Prevention and Control | Behavioral | The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Weight loss in kg | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose Level | Fasting glucose (mg/dL) | Baseline |
| Fasting Lipid Profile | LDL-cholesterol (mg/dL) | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth S Weinstock, MD, PhD | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21464685 | Background | Barham K, West S, Trief P, Morrow C, Wade M, Weinstock RS. Diabetes prevention and control in the workplace: a pilot project for county employees. J Public Health Manag Pract. 2011 May-Jun;17(3):233-41. doi: 10.1097/PHH.0b013e3181fd4cf6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years. |
| FG001 | Control | This is a "wait control" group, This group will begin the program (described in A,1) after 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years. Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight | Weight loss in kg | Participants from the wait-list "Control" Arm have been combined in the "Intervention" Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis. | Posted | Mean | 95% Confidence Interval | kg | 3 months |
|
1 year
Participants from the wait-list "Control" Arm have been combined in the "Intervention" Arm with those receiving the intervention immediately upon study entry for the purposes of Adverse Events collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Officer | SUNY Upstate Medical University | 315-464-5476 | Rudesj@upstate.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Hemoglobin A1c | hemoglobin A1c (%) | baseline |
| Waist Circumference | baseline, 3, 6, 12 months |
| Questionnaires | baseline, 3, 6, 12 months |
| BG001 | Control | This is a "wait control" group, This group will begin the program (described in A,1) after 3 months. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Fasting Glucose Level | Fasting glucose (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | Fasting Lipid Profile | LDL-cholesterol (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | Baseline |
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| Secondary | Hemoglobin A1c | hemoglobin A1c (%) | Posted | Mean | Standard Deviation | percent | baseline |
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| Secondary | Waist Circumference | Not Posted | baseline, 3, 6, 12 months |
| Secondary | Questionnaires | Not Posted | baseline, 3, 6, 12 months |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Control | This is a "wait control" group, This group will begin the program (described in A,1) after 3 months. | 0 | 24 | 0 | 24 |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |