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Clinical Trial NCT06003686 for Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of MiamiSpinal Cord Injury Model Systems (SCIMS) - Education Module
Clinical Trial NCT06003686 is an interventional study for Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome that is recruiting. It started on 5 March 2024 with plans to enroll 250 participants. Led by University of Miami, it is expected to complete by 31 October 2026. The latest data from ClinicalTrials.gov was last updated on 5 September 2025.
Brief Summary
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.
Official Title
A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
Conditions
Spinal Cord InjuriesObesityCardiometabolic SyndromeOther Study IDs
- 20230202
NCT ID Number
Start Date (Actual)
2024-03-05
Last Update Posted
2025-09-05
Completion Date (Estimated)
2026-10-31
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalParalyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group 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. | PVA Consumer Guide 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. |
Active ComparatorWebMD Group 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. | Webmd 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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) | 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. |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Men and Women with SCI/D aged 18-70 years.
- Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
- Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.
- Pregnancy determined by urine testing in sexually active females.
- Cognitive impairment that compromises the legitimacy of consent.
- Grade 3-4 pressure injury at the time of study entry.
- Prisoners
University of Miami290 active trials to exploreNational Institute on Disability, Independent Living, and Rehabilitation ResearchStudy Responsible Party
Gary Farkas, Principal Investigator, Principal Investigator, University of Miami
Study Central Contact
Contact: Patricia Graham, MS, 3052435119, [email protected]
3 Study Locations in 1 Countries
District of Columbia
MedStar National Rehabilitation Network, Washington D.C., District of Columbia, 20010, United States
Ana Aguirre, Contact, 202-877-1875, [email protected]
Suzanne Groah, MD, Principal Investigator
Recruiting
Florida
University of Miami - Miami Project to Cure Paralysis, Miami, Florida, 33136, United States
Gary S Farkas, PhD, Contact, 305-243-4518, [email protected]
Patricia Graham, MS, CCRC, Contact, 305-243-5119, [email protected]
Gary J Farkas, PhD, Principal Investigator
Recruiting
Texas
Baylor Scott & White Institute for Research, Dallas, Texas, 75246, United States
Jacqueline Nguyen, MPH, Contact, (469) 831-5321, [email protected]
Simon Driver, PhD, Principal Investigator
Not yet recruiting