An interventional study of PVA Consumer Guide and WebMD in Spinal Cord Injuries, Obesity and Cardiometabolic Syndrome, sponsored by University of Miami. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Behavioral: PVA Consumer Guide
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.
Behavioral: WebMD
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.
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.
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.
Time frame: baseline, up to 6 months
Change in Body Weight as determined by kilograms (kg)
Body weight will be measured in kilograms
Time frame: baseline, up to 6 months
Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
Body composition will be measured in grams using DXA
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: baseline, up to 6 months.
Plan to share: No
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