96 Participants Needed

Telenutrition for Obesity in Spinal Cord Injury

KS
CK
Overseen ByCria-May Khong
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Santa Clara Valley Health & Hospital System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nutrition counseling via FaceTime on an iPad can assist people with spinal cord injuries who are overweight or have obesity. The goal is to improve eating habits, potentially reducing the risk of high cholesterol, diabetes, and obesity-related issues. Participants will begin nutrition counseling either immediately or after a three-month wait. This trial suits individuals who have had a spinal cord injury for at least a year, primarily use a wheelchair, and reside in California. As an unphased trial, it offers a unique opportunity to explore innovative methods to enhance health and well-being.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a medical condition requiring a strict specialized diet or if your HbA1c is greater than 7%, you may not be eligible to participate.

What prior data suggests that telenutrition is safe for individuals with spinal cord injury?

Research has shown that telenutrition, which involves receiving nutrition advice through video calls, is generally safe and manageable. Studies have found that this type of counseling can help people with spinal cord injuries make healthier food choices. In one study, 9 out of 10 participants reported improved eating habits after three months of telenutrition.

Importantly, these studies have not reported any major safety issues. This is because the focus is on dietary changes and advice, rather than medication, which typically carries more risks. Overall, telenutrition appears to be a safe way to help people with spinal cord injuries lead healthier lives.12345

Why are researchers excited about this trial?

Researchers are excited about telenutrition for obesity in individuals with spinal cord injury because it leverages technology to deliver personalized nutrition counseling remotely. Unlike traditional in-person dietary consultations, telenutrition offers flexibility and accessibility, which is crucial for individuals who may have mobility challenges. It allows patients to receive consistent support and guidance without the need for frequent travel to clinics, potentially enhancing adherence to nutritional recommendations and improving outcomes.

What evidence suggests that telenutrition is effective for obesity in spinal cord injury?

Studies have shown that receiving nutrition advice through video calls, known as telenutrition, can benefit people with spinal cord injuries who are overweight or obese. One study found that 9 out of 10 participants made healthier food choices after three months of telenutrition counseling. This trial will evaluate two approaches: an immediate treatment group receiving three months of telenutrition followed by a three-month durability phase, and a delayed treatment group with a three-month waitlist period followed by three months of treatment. This method can improve diet quality and aid in weight management. It may also reduce risks like high cholesterol or diabetes. Overall, telenutrition appears to be a promising way to support better eating habits and health outcomes in this group.12345

Who Is on the Research Team?

KS

Kazuko Shem, MD

Principal Investigator

Santa Clara Valley Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 20 with traumatic spinal cord injury who are overweight, primarily use a wheelchair, and are at least one year post-injury. Participants must live in California, be able to use an iPad, attend three in-person visits at SCVMC, and speak English or Spanish. Those on specialized diets for medical conditions or involved in other diet programs recently cannot join.

Inclusion Criteria

I can make my own decisions and understand the consent form.
I use a wheelchair for most of my daily activities.
I am 20 years old or older.
See 6 more

Exclusion Criteria

Your HbA1c level is higher than 7%.
I have been diagnosed with an eating disorder in the past or currently.
I do not have any uncontrolled medical conditions like high blood pressure or severe infections.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive telenutrition counseling via FaceTime on an iPad, consisting of 6 sessions scheduled approximately 2 weeks apart

3 months
6 visits (virtual)

Durability Phase

Participants in the immediate treatment group are monitored for the durability of treatment effects

3 months
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Telenutrition
Trial Overview The study tests telenutrition counseling via FaceTime to help individuals with SCI improve their eating habits and heart health. It aims to reduce obesity-related risks like high cholesterol or diabetes and examine the relationship between nutrition and bowel/bladder function.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Immediate treatmentExperimental Treatment1 Intervention
Group II: Delayed TreatmentExperimental Treatment1 Intervention

Telenutrition is already approved in United States for the following indications:

🇺🇸
Approved in United States as Telenutrition for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Santa Clara Valley Health & Hospital System

Lead Sponsor

Trials
16
Recruited
4,500+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

San Jose State University

Collaborator

Trials
11
Recruited
1,900+

Published Research Related to This Trial

Individuals with spinal cord injury (SCI) are at a high risk for neurogenic obesity and metabolic dysfunction due to reduced energy expenditure and positive energy balance from excessive intake, highlighting the importance of dietary management.
The review emphasizes the need for nutrition education for healthcare professionals and individuals with SCI, recommending a diet rich in low-energy, nutrient-dense, anti-inflammatory foods to help achieve energy balance and mitigate obesity and metabolic issues.
Nutrition Education to Reduce Metabolic Dysfunction for Spinal Cord Injury: A Module-Based Nutrition Education Guide for Healthcare Providers and Consumers.Sneij, A., Farkas, GJ., Carino Mason, MR., et al.[2023]
In a study of 184 individuals with spinal cord injuries, the prevalence of overweight and obesity increased significantly from 56% to 75% over the years, highlighting a concerning trend in body mass index (BMI) post-rehabilitation.
While BMI did not significantly change during inpatient rehabilitation, there was a notable increase in the year following discharge, particularly among older individuals and men, suggesting the need for targeted weight-management strategies to promote healthier lifestyles.
Prospective analysis of body mass index during and up to 5 years after discharge from inpatient spinal cord injury rehabilitation.de Groot, S., Post, MW., Postma, K., et al.[2022]
In a study of 371 community-dwelling individuals with spinal cord injury (SCI), the prevalence of abdominal obesity was found to be 29.2%, similar to the 27.4% in the general population, indicating that obesity is a common issue in both groups.
The study revealed that only a small percentage of SCI individuals regularly monitored their waist circumference (28.8%) and body weight (48.8%), highlighting a need for targeted weight control programs that address their unique perceptions and socioeconomic factors related to obesity.
Characteristics of abdominal obesity in persons with spinal cord injury.Kim, KD., Nam, HS., Shin, HI.[2021]

Citations

NCT05468437 | Telenutrition for Individuals With SCIThis 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 ...
Nutrition counseling and monitoring via tele ...This study provides preliminary data suggesting that tele-nutrition is an efficacious intervention that may improve diet quality for individuals with SCI.
Telenutrition for Individuals With SCI - UCSF Clinical TrialsThis 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 ...
Telenutrition for Obesity in Spinal Cord InjuryA tele-nutrition counseling program over 3 months showed that 9 out of 10 participants with spinal cord injury reported improved healthy food choices, ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33606588/
Nutrition counseling and monitoring via tele ...This study provides preliminary data suggesting that tele-nutrition is an efficacious intervention that may improve diet quality for individuals with SCI.
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