Telenutrition for Individuals With SCI

Obesity Clinical Trial

Official title: Telenutrition to Improve Cardiometabolic Health and Quality of Life Among Individuals With Spinal Cord Injury

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The first phase of this study will include screening the participants' medical record for study eligibility. If potentially eligible, participants will partake in a secondary in-person screening assessment involving a fasting blood draw and weight, height, body fat, and waist circumference measurements. After the team receives the screening results and if participants continue to remain eligible, the second phase of the study (described below) will begin.

Following screening, participants will be enrolled into the 6-month study. Half of the enrolled participants will be scheduled for telenutrition counselling within the first three months of the study period. This group is called the "immediate treatment group". The other half will receive telenutrition counselling in the second three-month period. This group is called the "delayed treatment group". Participants will be informed which group they are assigned to and provided with details of the care that they will receive shortly after the screening phase is completed. Participants will have 50% chance of being assigned to the immediate treatment group and 50% chance of being assigned to the delayed treatment group.

Both groups will receive the same nutrition education and individualized nutrition counselling via videoconferencing 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 counselling 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. Participants will be involved in developing personal nutrition goals and the dietitian will help address barriers to meeting goals and provide individualized feedback to improve and maintain their nutrition. Telenutrition appointments will maintain privacy and will not be recorded.

To help participate in telenutrition sessions and complete the required assessments, each participant will receive an iPad mini with a 6-month data plan. Once study participation is complete, the investigators will stop the data plan but participants will get to keep the iPads. There are 3 outcome assessment spaced 3 months apart (baseline, short-term, and intermediate term). Each will include the same outcome assessments involving surveys, body measurements, and a blood draw. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05468437
• Study type: Interventional
• Source: Santa Clara Valley Health & Hospital System
• Contact: Kazuko Shem, MD
• Phone: 800-352-1956
• Email: kazuko.shem@hhs.sccgov.org
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2022
• Completion date: September 30, 2026