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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
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The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group | Experimental | Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months. |
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| WebMD Group | Active Comparator | Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVA Consumer Guide | Behavioral | Subject's will receive education on the PVA consumer guide 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the nutrition, exercise, and general healthy living guidelines content included. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Effectiveness of education modules as determined in the Knowledge Test | Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided. | baseline, up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight as determined by kilograms (kg) | Body weight will be measured in kilograms | baseline, up to 6 months |
| Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Graham, MS | Contact | 3052435119 | pgraham1@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gary Farkas, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar National Rehabilitation Network | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| WebMD | Behavioral | Subject's will receive education on how to navigate the WebMD site and find information on health, exercise and nutrition 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the health and wellness content available on the website. At study completion, subjects in this group will be provided with the PVA guide and a brief orientation of the nutrition, exercise, and general healthy living guidelines content included in the guide. |
|
Body composition will be measured in grams using DXA
| baseline, up to 6 months |
| Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage | Body composition will be expressed as a percentage of body fat (BF) using DXA | baseline, up to 6 months |
| Change in sugar metabolism as determined by Insulin resistance (IR) | Sugar metabolism will be determined as IR calculated using the formula (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity. Fasting values are obtained from blood samples | baseline, up to 6 months |
| Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III | A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant" | baseline, up to 6 months |
| Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set | QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). | baseline, up to 6 months |
| Change in heart disease risk as determined by cholesterol | Risk of heart disease will be measured from a blood sample in mg/dL | baseline, up to 6 months. |
| Change in heart disease risk as determined by blood pressure (BP) | BP will be measured in mmHg using an arm cuff | baseline, up to 6 months. |
| University of Miami - Miami Project to Cure Paralysis | Recruiting | Miami | Florida | 33136 | United States |
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| Baylor Scott & White Institute for Research | Not yet recruiting | Dallas | Texas | 75246 | United States |
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| D014947 | Wounds and Injuries |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |