Spinal Cord Injury Model Systems (SCIMS) - Education Module
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PVA Consumer Guide
BehavioralSubject'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.
WebMD
BehavioralSubject'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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide GroupExperimental treatment 1 intervention
Group B: WebMD GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Change in Body Weight as determined by kilograms (kg)
Body weight will be measured in kilograms
Time frame
baseline, up to 6 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov