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NCT Number: NCT05468437

Telenutrition for Individuals With SCI

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.

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Key information

Conditions

Spinal Cord Injuries Body Weight Cardiometabolic Syndrome Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Medical instability (e.g., uncontrolled hypertension, pneumonia, severe pressure injury)
  • Current self-reported pregnancy
  • Other medical condition requiring a strict specialized diet (e.g., renal failure, diabetes)
  • 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
  • Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
  • Receiving enteral nutrition
  • Individuals without a primary care physician
  • 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)
  • Individuals who are in law enforcement custody

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cria-May Khong

CONTACT

[email protected]

800-352-1956

Kazuko Shem, MD

CONTACT

[email protected]

800-352-1956

Sponsors and collaborators

Lead sponsor

Santa Clara Valley Health & Hospital System

Other

Collaborators

  • San Jose State University
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2022
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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