Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06003686

Conditions

Spinal Cord Injuries

Obesity

Cardiometabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

PVA Consumer Guide

WebMD

Study Details

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.

Conditions

Spinal Cord Injuries

Obesity

Cardiometabolic Syndrome

Study ID

NCT06003686

Start date

Mar 5, 2024

Status verified date

Apr, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Paralyzed 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.

active comparator: WebMD 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.

Interventions

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.

Primary outcome measure

  • Change in Effectiveness of education modules as determined in the Knowledge Test [ Time Frame: baseline, up to 6 months ]

Central Contacts and Locations

Central contacts

Patricia Graham, MS

3052435119pgraham1@med.miami.edu

Locations

MedStar National Rehabilitation Network

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Ana Aguirre

202-877-1875AnaValeria.AguirreGuemez@medstar.net

Principal Investigator:

Suzanne Groah, MD

University of Miami - Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Gary S Farkas, PhD

305-243-4518gjf50@med.miami.edu

Patricia Graham, MS, CCRC

305-243-5119pgraham1@med.miami.edu

Principal Investigator:

Gary J Farkas, PhD

More Information

Sponsor

University of Miami

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-20.