Telehealth Nutrition Sessions for Brain Injury

(HOME Trial)

Overseen By Linda L Knol, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Pregnant, Breastfeeding, Outside Alabama, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether personalized nutrition counseling, also known as Medical Nutrition Therapy, can improve diet quality for individuals with a history of brain injury. Participants will either receive three telehealth sessions with a Registered Dietitian or a packet of nutrition handouts. The researchers aim to determine if the sessions lead to better eating habits compared to just receiving handouts. The trial seeks individuals who have experienced a brain injury, live at home in Alabama, and have internet access for Zoom sessions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance dietary support for brain injury recovery.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on nutrition counseling, so it's unlikely that you would need to change your medications, but you should confirm with the trial organizers.

What prior data suggests that telehealth nutrition sessions are safe for individuals with brain injury?

Research has shown that nutrition counseling is generally safe and well-tolerated for people with brain injuries. Studies have found that good nutrition can help manage health issues like diabetes, high blood pressure, and obesity, which often occur after a brain injury.

No strong evidence exists of serious side effects from nutrition therapy. Instead, it focuses on improving diet quality with help from a Registered Dietitian. Participants learn about their nutritional needs, set goals, and find ways to overcome challenges. This support can enhance their overall health without any known risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth Nutrition Sessions for Brain Injury because they offer a personalized approach through Medical Nutrition Therapy. Unlike standard dietary recommendations, which often involve generic advice or handouts, this method provides individualized counseling in virtual one-on-one sessions with a Registered Dietitian. This personalized attention helps address specific nutritional needs and barriers faced by brain injury patients, and the telehealth format makes it accessible regardless of location, ensuring that even those with mobility challenges can benefit. Additionally, involving caregivers in the sessions ensures support and better adherence to the nutrition plan, potentially leading to improved outcomes in dietary habits and overall health.

What evidence suggests that nutrition counseling could improve dietary intake for individuals with brain injury?

Research has shown that nutrition therapy can aid people with brain injuries. Studies have found that a healthy diet can reduce infection risk and enhance recovery for these patients. Nutrition therapy also correlates with improved brain function and shorter hospital stays. For those living in the community after a brain injury, a healthier diet can help manage high blood pressure, diabetes, and obesity. In this trial, participants in the intervention group will receive Medical Nutrition Therapy through sessions with a Registered Dietitian. Evidence supports that this approach can lead to better health and improved diet quality for these individuals. ^{2 4 5 6 7}

Who Is on the Research Team?

Joy W Douglas, PhD

Principal Investigator

The University of Alabama

Linda L Knol, PhD

Principal Investigator

The University of Alabama

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in Alabama with a history of brain injury, who are now back home. They need internet access to join Zoom sessions. It's not for those under 18, without brain injury history, living outside Alabama or in care facilities, nor for pregnant/breastfeeding individuals or those unable to consent.

Inclusion Criteria

Have internet access to join Zoom sessions

History of brain injury

Live in Alabama

Exclusion Criteria

I have never had a brain injury.

Lives outside of Alabama

Currently in a hospital, rehabilitation facility, group home, or other location other than 'home'

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three individualized nutrition counseling sessions with a Registered Dietitian or standard of care (handouts)

6 weeks

3 sessions (telehealth)

Follow-up

Participants are monitored for changes in diet quality and stress-related eating after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medical Nutrition Therapy

Trial Overview The study tests if individualized nutrition counseling by a Registered Dietitian via telehealth can improve diet quality compared to just receiving handouts. Participants will have dietary recalls and either get three personalized nutrition sessions or standard handouts.

How Is the Trial Designed?

Group I: Medical Nutrition Therapy Experimental Treatment 1 Intervention

The intervention group will be scheduled for three one-on-one sessions with a Registered Dietitian, where they will receive nutrition education and counseling. Sessions with the Registered Dietitian will include a review of the client's nutrition assessment data, development of problem list with the client, nutrition diagnosis, assessment of motivation to change, a discussion of barriers and facilitators, an intervention plan, goal setting, and monitoring and evaluation. Because individuals with brain injury may not do their own grocery shopping and meal preparation, caregivers will be encouraged to attend sessions. Checklists will be used to ensure treatment fidelity across participants and nutrition sessions. Sessions will be conducted by telehealth and will be recorded for fidelity checks and ongoing research team training. Sessions will be scheduled approximately 2 weeks apart.

Group II: Nutrition Handout Packet Active Control 1 Intervention

The control group will receive a packet of nutrition education handouts from the MyPlate program found at USDA.gov. The handouts are publicly available and represent nutrition information that could be readily accessed by individuals who want to change their dietary habits, but do not have access to services from a Registered Dietitian.

Medical Nutrition Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medical Nutrition Therapy for:

• Diabetes management
• High blood pressure management
• High cholesterol management
• Weight management
• Obesity management

Approved in European Union as Medical Nutrition Therapy for:

• Nutritional disorders
• Metabolic disorders
• Gastrointestinal disorders
• Cardiovascular diseases

Approved in Canada as Medical Nutrition Therapy for:

• Chronic disease management
• Nutrition-related disorders
• Weight management

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

Academy of Nutrition and Dietetics

Collaborator

Trials

25

Recruited

5,600+

Published Research Related to This Trial

Nutritional therapy is crucial for head-injured patients to prevent the loss of lean body mass and to support recovery, highlighting the importance of early nutritional support alongside physical therapy for better long-term rehabilitation outcomes.

Critical care nurses play a vital role in delivering nutritional support while also stabilizing the patient's hemodynamic and neurological status, ensuring comprehensive care during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional support and head trauma. Varella, LD.[2004]

The study analyzed outpatient telenutrition service utilization data from 2012 to 2020, revealing a total of 6,212 referrals and 2,880 consultations across 56 clinics, indicating a significant level of engagement with the service.

The introduction of a Direct-To-Consumer modality during the COVID-19 pandemic helped maintain service utilization, preventing a 36.7% drop in consultations, highlighting the effectiveness of telenutrition in providing care without requiring travel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Utilization of an Outpatient Telenutrition Service Across Primary Care Clinics in South Carolina. Gehring, LN., Hales, SB., Kruis, R., et al.[2023]

In a study of 22 patients with moderate traumatic brain injury, both enteral nutrition (EN) and parenteral nutrition (TPN) provided adequate calorie supply, but TPN resulted in significantly higher serum glucose levels compared to EN.

Despite TPN supplying more nitrogen, both nutrition routes achieved similar nitrogen balance, and neither method influenced clinical outcomes or the acute inflammatory response in the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral or parenteral nutrition in traumatic brain injury: a prospective randomised trial. Justo Meirelles, CM., de Aguilar-Nascimento, JE.[2015]

Malnutrition is common in stroke patients and can worsen brain damage and recovery outcomes, highlighting the need for early identification and management of nutritional deficits.

Nutritional interventions, including dietary modifications and specialized nutrition support like enteral tube feeding, are crucial during stroke recovery to enhance neurocognitive function and prevent complications from energy-protein deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition in patients with acute stroke. Bouziana, SD., Tziomalos, K.[2021]

Nutritional therapy is critical for patients with traumatic brain injury (TBI) as undernutrition can lead to higher mortality rates and worse neurological outcomes, emphasizing the need for timely intervention.

The review highlights key considerations for nutritional management in TBI patients, including energy expenditure, enteral versus parenteral nutrition, and the importance of protein support, while also identifying gaps in current research that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Management in Patients With Traumatic Brain Injury: A Narrative Review. Lee, HY., Oh, BM.[2023]

A young man with severe brain injury and malnutrition showed significant improvement in weight and metabolic health after receiving a nutritional intervention that included artificial nutrition and natural foods through a PEG tube over the course of a year.

The integration of natural foods into the patient's diet not only helped restore normal weight but also contributed to regaining consciousness and reducing recovery times, highlighting the importance of nutrition in rehabilitation after severe brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of malnutrition in a patient with severe brain injury outcomes: A case report. Caliri, S., Andaloro, A., Corallo, F., et al.[2022]

Medical Nutrition Therapy (MNT) in Canada is currently unregulated, allowing anyone to provide nutrition advice, which can lead to unsafe or ineffective recommendations and delayed treatment for health conditions.

To address the risks of misinformation and improve public health, the paper advocates for a standardized definition of MNT and regulatory changes across provinces and territories to ensure that only qualified professionals, like registered dietitians, provide nutrition advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a Standardized Definition of Medical Nutrition Therapy and Regulatory Reform in Canada. Keathley, JR., Arbour, A., Vohl, MC.[2022]

Early introduction of tailored nutrition therapy is crucial for improving outcomes in head trauma patients, as they experience a hypermetabolic state that increases their specific nutritional needs.

Recommendations for effective nutrition therapy include enteral administration, appropriate energy intake, and close monitoring of electrolytes and metabolism, although specific guidelines are still lacking in the current literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy in severe head trauma patients. Campos, BB., Machado, FS.[2022]

Optimal nutrition therapy is crucial for improving recovery outcomes in adults with moderate to severe traumatic brain injury (TBI), but current evidence is inconsistent and insufficient for creating best practice guidelines.

A scoping review of 20 articles revealed gaps in research regarding the timing, route of administration, and specific nutrients for TBI nutrition interventions, highlighting the need for further studies to establish effective nutritional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy in the optimisation of health outcomes in adult patients with moderate to severe traumatic brain injury: findings from a scoping review. Costello, LA., Lithander, FE., Gruen, RL., et al.[2014]

The use of nutrition-oriented information software significantly improved the timing and effectiveness of enteral nutrition (EN) in adult patients with severe traumatic brain injury (sTBI), with earlier initiation of EN and higher total protein and energy supply compared to the control group.

Patients managed with the software showed better serum cholinesterase levels after 14 days, indicating improved nutritional status, although other critical care outcomes like ICU survival rates and duration of mechanical ventilation did not show significant differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of the effect of target-directed treatment based on nutrition-oriented information software on nutritional compliance rate in adults with severe traumatic brain injury: a mixed cohort study]. Zhou, P., Pan, H., Zhu, X., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9833460/

Nutrition Management in Patients With Traumatic Brain Injury In patients with TBI, undernutrition is associated with an increased mortality rate, more infectious complications, and worse neurologic outcomes.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666149723000361

Nutrition therapy in critically ill patients with traumatic brain ... The aim of this review is to provide an overview of the current evidence-based nutrition therapy for patients with TBI in critical care settings.

3. link.springer.com link.springer.com/article/10.1007/s40141-023-00413-7

Brain Injury: How Dietary Patterns Impact Long-Term ... This review discusses dietary patterns as a means of addressing modifiable risk factors following TBI exposure. Evidence-based resources for ...

4. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00190/full

Nutrition Therapy, Glucose Control, and Brain Metabolism ... In this review, we summarize data from clinical research on patients with severe TBI focused on a multimodal approach to evaluate aspects of nutrition therapy.

5. apm.amegroups.org apm.amegroups.org/article/view/84216/html

Systematic review and meta-analysis of the effect of nutritional ... Nutritional support effectively shortens the hospital stay of patients, reduces the infection rate of patients, and has a positive effect on promoting ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK209331/

Summary - Nutrition and Traumatic Brain Injury - NCBI Bookshelf This report emphasizes the importance of nutrition not only to augment overall defensive mechanisms against the effects of TBI but also as postinjury treatment ...

7. mdpi.com mdpi.com/2227-9059/11/9/2551

Optimization of Nutrition after Brain Injury: Mechanistic and ... In this review, we will describe how malnutrition impacts the biomolecular mechanisms of secondary brain injury in acute neurological disorders.