Telenutrition for Individuals With SCI

Part of paid clinical trials in San Jose, California.

Sponsor
Santa Clara Valley Health & Hospital System
Study ID
NCT05468437
Status
Recruiting
Apply to this trial

Conditions

  • Cardiometabolic Syndrome
  • Obesity
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telenutrition — BEHAVIORAL
    Nutrition education and individualized nutrition counseling will be done with a Registered Dietitian via video-conferencing with iPad FaceTime, which is aimed to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. The telenutrition counseling consists of 6 sessions that are scheduled approximately 2 weeks apart. The first session will last approximately 1 hour, while sessions 2-6 will last approximately 30mins. During these sessions, the Registered Dietitian will share nutrition education tailored towards people with SCI. You will be involved in developing personal nutrition goals and the dietitian will help you address barriers to meeting your goals and provide individualized feedback to improve and maintain your nutrition. Telenutrition appointments will maintain privacy and will not be recorded.

Study Details

This study will provide nutrition counseling via FaceTime on an iPad to persons with traumatic spinal cord injury (SCI) who are overweight or obese and are at least one-year post-injury. Nutrition counseling may help participants to develop eating behaviors that match the participants' needs and help improve heart health. The purpose of this project is to decrease the risk of complications like obesity, high cholesterol, or diabetes, and explore associations between bowel and bladder function and nutrition. This study will require 3 in person visits that are about 3 months apart. The total length of the study is about 6 months and includes 3 months of telenutrition counseling.

Key Dates

Start date
Jun 13, 2022
Status verified
May 2025
Primary completion
Jan 1, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate treatment
    Three months of treatment followed by a 3 month durability phase
  • Experimental: Delayed Treatment
    A 3 month waitlist period followed by 3 months of treatment

Primary Outcome Measure

Healthy Eating Index (HEI) scores [ Time Frame: 0, 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Santa Clara Valley Medical CenterSan JoseCalifornia95128
Kazuko Shem, MD
[email protected]
800-352-1956
Ben Dirlikov, MA
[email protected]
4087818175

Find similar trials in San Jose, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Santa Clara Valley Medical Center· San Jose, CA

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