Telenutrition for Obesity in Spinal Cord Injury

Overseen By Cria-May Khong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Santa Clara Valley Health & Hospital System

Must not be taking: Anti-diabetics

Disqualifiers: Uncontrolled hypertension, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 3 months

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is telenutrition safe for people with spinal cord injury?

The research does not provide specific safety data for telenutrition, but it generally involves remote nutrition counseling, which is considered safe as it focuses on dietary advice and monitoring. ^{1 2 3 4 5}

How is the treatment Telenutrition unique for obesity in spinal cord injury?

Telenutrition is unique because it provides nutrition counseling through telehealth, allowing people with spinal cord injury to receive personalized dietary guidance remotely, which can improve diet quality, weight management, and overall quality of life without needing to visit a healthcare facility. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Telenutrition for Obesity in Spinal Cord Injury?

Research shows that tele-nutrition counseling can improve diet quality and potentially help manage weight and waist circumference in people with spinal cord injury, suggesting it could be an effective approach for addressing obesity in this group. ^{1 3 4 7 8}

Who Is on the Research Team?

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.

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.

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?

Group I: Immediate treatment Experimental Treatment 1 Intervention

Three months of treatment followed by a 3 month durability phase

Group II: Delayed Treatment Experimental Treatment 1 Intervention

A 3 month waitlist period followed by 3 months of treatment

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

Approved in United States as Telenutrition for:

• Spinal Cord Injury-related obesity
• Cardiometabolic Syndrome
• Metabolic Syndrome

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

A tele-nutrition counseling program over 3 months showed that 9 out of 10 participants with spinal cord injury reported improved healthy food choices, indicating potential efficacy in enhancing diet quality.

Participants expressed high satisfaction with the program, rating it 97-100% in terms of perceived health benefits and overall satisfaction, despite no significant changes in weight or waist circumference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition counseling and monitoring via tele-nutrition for healthy diet for people with spinal cord injury: A case series analyses. Wood, S., Khong, CM., Dirlikov, B., et al.[2022]

In a study of 1524 patients with traumatic spinal cord injury, approximately 25% were obese, and obesity negatively impacted self-care and mobility improvements, particularly in patients with incomplete and complete paraplegia.

Obese patients with paraplegia showed significantly lower gains in self-care and mobility scores compared to normal-weight patients, indicating that obesity may hinder rehabilitation outcomes, although discharge to the community was similar for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and inpatient rehabilitation outcomes for patients with a traumatic spinal cord injury. Stenson, KW., Deutsch, A., Heinemann, AW., et al.[2011]

Patients with spinal cord injury (SCI) consumed significantly more calories (1,967.9 kcal) compared to those with new traumatic brain injury (TBI), stroke, and Parkinson's disease, indicating a need for tailored dietary management in acute rehabilitation settings.

While protein intake was higher in the SCI group (71.5 g) compared to other diagnoses, the differences were not statistically significant, suggesting that while calorie intake is a concern, protein intake may require further investigation for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calorie and protein intake in acute rehabilitation inpatients with traumatic spinal cord injury versus other diagnoses. Pellicane, AJ., Millis, SR., Zimmerman, SE., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Chronic spinal cord injured individuals consume only 75% of the recommended caloric intake, relying heavily on fats for calories, which accounted for 37.9% of their diet, exceeding the recommended 30%.

There are significant deficiencies in dietary fiber and various vitamins and minerals, indicating a need for nutritional intervention and education, highlighting the importance of including a registered dietitian in the healthcare team for SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An examination of dietary intakes and nutritional status of chronic healthy spinal cord injured individuals. Levine, AM., Nash, MS., Green, BA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of abdominal obesity in persons with spinal cord injury. Kim, KD., Nam, HS., Shin, HI.[2021]

A quality improvement initiative significantly increased nutrition screening compliance among spinal cord injury patients from 49.3% in 2013-2014 to 76.7% in 2016-2017, indicating progress in addressing nutritional needs post-injury.

The systematic review revealed that malnutrition is prevalent in 40-50% of spinal cord injury patients, while overweight affects 45-69.2%, highlighting the urgent need for effective screening and intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting malnutrition risk and obesity after spinal cord injury: a quality improvement project and systematic review. Wong, S., Kenssous, N., Hillier, C., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nutrition counseling and monitoring via tele-nutrition for healthy diet for people with spinal cord injury: A case series analyses. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Obesity and inpatient rehabilitation outcomes for patients with a traumatic spinal cord injury. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Calorie and protein intake in acute rehabilitation inpatients with traumatic spinal cord injury versus other diagnoses. [2021]

4. Sweden pubmed.ncbi.nlm.nih.gov

Prospective analysis of body mass index during and up to 5 years after discharge from inpatient spinal cord injury rehabilitation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

An examination of dietary intakes and nutritional status of chronic healthy spinal cord injured individuals. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Characteristics of abdominal obesity in persons with spinal cord injury. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Detecting malnutrition risk and obesity after spinal cord injury: a quality improvement project and systematic review. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition Education to Reduce Metabolic Dysfunction for Spinal Cord Injury: A Module-Based Nutrition Education Guide for Healthcare Providers and Consumers. [2023]