Summary

Eligibility
for people ages 20 years and up (full criteria)
Location
at San Jose, California
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Spinal Cord Injuries, Obesity, Cardiometabolic Syndrome, Spinal Cord injury, Cardiometabolic, cardiovascular, bowel, bladder, nutrition, telehealth, Metabolic Syndrome, Telenutrition

Eligibility

You can join if…

Open to people ages 20 years and up

  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

You CAN'T join if...

  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

Location

  • Santa Clara Valley Medical Center accepting new patients
    San Jose California 95128 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Santa Clara Valley Health & Hospital System
ID
NCT05468437
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated