Telehealth Nutrition Sessions for Brain Injury

(HOME Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Linda L Knol, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Pregnant, Breastfeeding, Outside Alabama, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to see if personalized nutrition counseling can help people with a history of brain injury eat healthier. Participants will receive either personalized advice from a dietitian or general nutrition information. The goal is to determine if the personalized advice leads to better eating habits.

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 data supports the effectiveness of the treatment Medical Nutrition Therapy, Nutrition Counseling, Dietary Therapy, Nutrition Therapy for brain injury?

Research shows that nutritional therapy can help improve recovery in patients with brain injuries by providing the necessary calories and nutrients to support healing and reduce complications. Effective nutrition management is crucial for better outcomes in traumatic brain injury, as it helps prevent malnutrition, which is linked to worse recovery and more infections. ^{1 2 3 4 5}

Is nutritional therapy safe for humans?

Nutritional therapy, which includes providing necessary calories and nutrients, is generally considered safe and important for recovery in patients with brain injuries. However, it is crucial that it is administered by trained professionals to ensure it meets specific patient needs and avoids potential risks associated with unregulated advice. ^{1 3 6 7 8}

How is the treatment Medical Nutrition Therapy unique for brain injury?

Medical Nutrition Therapy for brain injury is unique because it focuses on providing essential nutrients and calories to support recovery and rehabilitation, which can help prevent malnutrition and improve outcomes. Unlike other treatments, it can be delivered through telehealth, allowing patients to receive guidance and support without needing to travel. ^{1 3 5 9 10}

Research Team

Joy W Douglas, PhD

Principal Investigator

The University of Alabama

Linda L Knol, PhD

Principal Investigator

The University of Alabama

Eligibility Criteria

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

I am 18 years old or older.

Have internet access to join Zoom sessions

History of brain injury

Exclusion Criteria

I am younger than 18 years old.

I have never had a brain injury.

Lives outside of Alabama

Trial Timeline

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

Treatment Details

Interventions

• Medical Nutrition Therapy (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Recovery of malnutrition in a patient with severe brain injury outcomes: A case report. [2022]

2. China 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]. [2021]

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

Nutrition Management in Patients With Traumatic Brain Injury: A Narrative Review. [2023]

4. Netherlands 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. [2014]

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

Malnutrition in patients with acute stroke. [2021]

6. Brazil pubmed.ncbi.nlm.nih.gov

Nutrition therapy in severe head trauma patients. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Enteral or parenteral nutrition in traumatic brain injury: a prospective randomised trial. [2015]

8. Canada pubmed.ncbi.nlm.nih.gov

Towards a Standardized Definition of Medical Nutrition Therapy and Regulatory Reform in Canada. [2022]

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

Nutritional support and head trauma. [2004]

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

Examining Utilization of an Outpatient Telenutrition Service Across Primary Care Clinics in South Carolina. [2023]