Telenutrition for Individuals With SCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Spinal Cord Injuries; Cardiometabolic Syndrome
• Intervention / Treatment: Behavioral: Telenutrition

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kazuko Shem, MD; Phone Number: 800-352-1956; Email: Kazuko.Shem@hhs.sccgov.org
• Study Contact Backup: Name: Cria-May Khong; Phone Number: 800-352-1956; Email: cria-may.khong@hhs.sccgov.org

Study Locations

• United States
  • California
    • San Jose, California, United States, 95128
      • Recruiting
      • Santa Clara Valley Medical Center
      • Contact: Kazuko Shem, MD; Phone Number: 800-352-1956; Email: Kazuko.Shem@hhs.sccgov.org
      • Contact: Ben Dirlikov, MA; Phone Number: 4087818175; Email: Ben.Dirlikov@hhs.sccgov.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals with traumatic SCI
2. At least 1-year post-injury
3. Age 20 years of age or older
4. BMI > 22 kg/m2 at enrollment
5. Proficiency in English or Spanish
6. Living at home or in a private home setting (i.e., not an extended care facility) in the state of California
7. Able / willing to come to SCVMC for in-person assessments
8. Primarily a wheelchair user (>40 hours per week)
9. Able to use, or learn how to use, an iPad
10. Possess adequate decision-making capacity to provide independent informed consent

Exclusion Criteria:

1. Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
2. Current self-reported pregnancy
3. Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes)
4. Participation in another diet program (e.g., Jenny Craig, Weight Watchers, clinic-based program) and/or participated in another diet program within the past 6 months
5. Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
6. Receiving enteral nutrition
7. Individuals without a primary care physician
8. HbA1c >7% (these individuals would need to be treated with metformin or other anti-diabetic medication and the intervention would have to be significantly altered for them)
9. Individuals who are in law enforcement custody

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate treatment; Three months of treatment followed by a 3 month durability phase	Behavioral: Telenutrition; 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.
Experimental: Delayed Treatment; A 3 month waitlist period followed by 3 months of treatment	Behavioral: Telenutrition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy Eating Index (HEI) scores	HEI scores from participants' individual dietary intakes at different time-points of evaluations (baseline/pre-intervention, end of 3 months from baseline, end of 6 months from baseline) will be reported. Changes in HEI scores following intervention will be compared to pre-intervention baseline scores (within group comparison) as well as scores from the waitlisted group (between group comparison) and reported accordingly. In addition, longer-term changes in HEI scores (for individuals from the immediate intervention group) during the durability phase will also be reported.	0, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood lipid profile	Lipid profile constituting of Triglycerides (TG), Total Cholesterol (TC); low-density lipoprotein (LDL) and High-density lipoprotein (HDL)- values (all expressed as mg/dL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes in values will also be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
HbA1C	Blood values of HbA1C (expressed as percentage) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in percent values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Vitamin D	Blood values of Vitamin D (expressed as ng/mL) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
high-sensitivity C-reactive protein [hs-CRP]	Blood values of hs-CRP (expressed as mg/L) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). In addition, absolute changes will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group)	0, 3 and 6 months
Body Mass Index (BMI)	Multiple measures (weight in kg and height in meters) will be aggregated to arrive at one reported BMI values (expressed as kg/m^2). BMI values will be reported at all time-points of evaluations (baseline, end of 3 months and at the end of 6 months). Absolute changes in values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Waist circumference	Waist circumference (in inches) will be reported at all time-points of evaluations (baseline, end of 3 months and at the end of 6 months). Absolute changes in values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Fat percent	Fat percent (%) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in percentage values will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Bowel function	Changes in bowel function (as determined by the Simon Fraser University (SFU) bowel survey questions based on a rating scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in perceived rating will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Bladder function	Changes in bladder function (as determined by the SF-Qualiveen survey expressed as a score) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in scores will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Quality of Life (Qol) measure	Changes in Qol [using the Satisfaction With Life Scale (SWLS) survey based on a rating scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in perceived ratings will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months
Frequency of Autonomic Dysreflexia (AD)	Changes in frequency of AD (as determined by the SFU AD survey questions expressed on a 5-point likert scale) will be reported at all time-points of evaluations (baseline/pre-intervention, end of 3 months and at the end of 6 months). Changes in rating will be reported following intervention compared to pre-intervention levels (within group comparison) and waitlisted group (between group comparison) as well as during the durability phase (for the immediate intervention group).	0, 3 and 6 months

Collaborators and Investigators

• Sponsor: Santa Clara Valley Health & Hospital System
• Collaborators: University of California, San Francisco; San Jose State University
• Investigators: Principal Investigator: Kazuko Shem, MD, Santa Clara Valley Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; nutrition; bladder; cardiovascular; telehealth; bowel; Cardiometabolic; Spinal Cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Trauma, Nervous System; Spinal Cord Diseases; Metabolic Syndrome; Spinal Cord Injuries
• Other Study ID Numbers: 21-038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No