RECRUITING

Telenutrition for Individuals With SCI

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-06-13

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05468437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Study Contact

Kazuko Shem, MD

CONTACT

800-352-1956

kazuko.shem@hhs.sccgov.org

Cria-May Khong

CONTACT

800-352-1956

cria-may.khong@hhs.sccgov.org

Principal Investigator

Kazuko Shem, MD

PRINCIPAL_INVESTIGATOR

Santa Clara Valley Medical Center

Study Locations (Sites)

Santa Clara Valley Medical Center

San Jose, California, 95128

United States

Collaborators and Investigators

Sponsor: Santa Clara Valley Health & Hospital System

Kazuko Shem, MD, PRINCIPAL_INVESTIGATOR, Santa Clara Valley Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-13

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-06-13

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Spinal Cord injury
Obesity
Cardiometabolic
cardiovascular
bowel
bladder
nutrition
telehealth

Additional Relevant MeSH Terms

Spinal Cord Injuries
Obesity
Cardiometabolic Syndrome