134 Participants Needed

Telehealth Nutrition Sessions for Brain Injury

(HOME Trial)

JW
LL
Overseen ByLinda L Knol, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama, Tuscaloosa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.13678

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.136910

Who Is on the Research Team?

JW

Joy W Douglas, PhD

Principal Investigator

The University of Alabama

LL

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
See 1 more

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'
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Medical Nutrition TherapyExperimental Treatment1 Intervention
Group II: Nutrition Handout PacketActive Control1 Intervention

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

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Approved in United States as Medical Nutrition Therapy for:
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Approved in European Union as Medical Nutrition Therapy for:
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Approved in Canada as Medical Nutrition Therapy for:

Find a Clinic Near You

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

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

Citations

Recovery of malnutrition in a patient with severe brain injury outcomes: A case report. [2022]
[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]
Nutrition Management in Patients With Traumatic Brain Injury: A Narrative Review. [2023]
Nutrition therapy in the optimisation of health outcomes in adult patients with moderate to severe traumatic brain injury: findings from a scoping review. [2014]
Malnutrition in patients with acute stroke. [2021]
Nutrition therapy in severe head trauma patients. [2022]
Enteral or parenteral nutrition in traumatic brain injury: a prospective randomised trial. [2015]
Towards a Standardized Definition of Medical Nutrition Therapy and Regulatory Reform in Canada. [2022]
Nutritional support and head trauma. [2004]
10.United Statespubmed.ncbi.nlm.nih.gov
Examining Utilization of an Outpatient Telenutrition Service Across Primary Care Clinics in South Carolina. [2023]
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