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Telenutrition for Individuals With SCI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05468437
Recruitment Status : Recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Collaborators:
San Jose State University
University of California, San Francisco
Information provided by (Responsible Party):
Santa Clara Valley Health & Hospital System

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Obesity Cardiometabolic Syndrome Behavioral: Telenutrition Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a wait-list control study. Individuals in the immediate treatment group will receive the intervention in the first 3 months, followed by a 3 month durability phase. The delayed treatment group will receive the intervention in the second 3 month period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telenutrition to Improve Cardiometabolic Health and Quality of Life Among Individuals With Spinal Cord Injury
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : January 1, 2026
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Healthy Eating Index (HEI) scores [ Time Frame: 0, 3 and 6 months ]
    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.


Secondary Outcome Measures :
  1. Blood lipid profile [ Time Frame: 0, 3 and 6 months ]
    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).

  2. HbA1C [ Time Frame: 0, 3 and 6 months ]
    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).

  3. Vitamin D [ Time Frame: 0, 3 and 6 months ]
    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).

  4. high-sensitivity C-reactive protein [hs-CRP] [ Time Frame: 0, 3 and 6 months ]
    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)

  5. Body Mass Index (BMI) [ Time Frame: 0, 3 and 6 months ]
    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).

  6. Waist circumference [ Time Frame: 0, 3 and 6 months ]
    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).

  7. Fat percent [ Time Frame: 0, 3 and 6 months ]
    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).

  8. Bowel function [ Time Frame: 0, 3 and 6 months ]
    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).

  9. Bladder function [ Time Frame: 0, 3 and 6 months ]
    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).

  10. Quality of Life (Qol) measure [ Time Frame: 0, 3 and 6 months ]
    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).

  11. Frequency of Autonomic Dysreflexia (AD) [ Time Frame: 0, 3 and 6 months ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468437


Contacts
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Contact: Kazuko Shem, MD 800-352-1956 kazuko.shem@hhs.sccgov.org
Contact: Cria-May Khong 800-352-1956 cria-may.khong@hhs.sccgov.org

Locations
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United States, California
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Kazuko Shem, MD    800-352-1956    Kazuko.Shem@hhs.sccgov.org   
Contact: Ben Dirlikov, MA    4087818175    Ben.Dirlikov@hhs.sccgov.org   
Sponsors and Collaborators
Santa Clara Valley Health & Hospital System
San Jose State University
University of California, San Francisco
Investigators
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Principal Investigator: Kazuko Shem, MD Santa Clara Valley Medical Center
More Information
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Responsible Party: Santa Clara Valley Health & Hospital System
ClinicalTrials.gov Identifier: NCT05468437    
Other Study ID Numbers: 21-038
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santa Clara Valley Health & Hospital System:
Spinal Cord injury
Obesity
Cardiometabolic
cardiovascular
 bowel
bladder
nutrition
telehealth
Additional relevant MeSH terms:
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Spinal Cord Injuries
Metabolic Syndrome
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases