Spinal Cord Injury Model Systems (SCIMS) - Education Module

Obesity Clinical Trial

Official title:

A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003686
• Other study ID #: 20230202
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Patricia Graham, MS
• Phone: 3052435119
• Email: pgraham1[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Men and Women with SCI/D aged 18-70 years.

2. Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.

3. Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.

Exclusion Criteria:

1. Pregnancy determined by urine testing in sexually active females.

2. Cognitive impairment that compromises the legitimacy of consent.

3. Grade 3-4 pressure injury at the time of study entry.

4. Prisoners

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome
• Obesity
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Baylor Scott & White Institute for Research	Dallas	Texas
United States	University of Miami - Miami Project to Cure Paralysis	Miami	Florida
United States	University of Minnesota Rehabilitation	Minneapolis	Minnesota
United States	McGuire Research Institute Richmond VA Medical Center	Richmond	Virginia
United States	MedStar National Rehabilitation Network	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Change in Body Weight as determined by kilograms (kg)	Body weight will be measured in kilograms	baseline, up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.