What is the mechanism of action of this treatment?

Common treatments for Traumatic Brain Injury (TBI) include medical management to reduce intracranial pressure, surgical interventions to remove hematomas, and rehabilitation therapies to improve cognitive and physical function. The mechanisms of action for these treatments involve stabilizing the patient, preventing secondary brain injury, and promoting recovery through targeted therapies. Individualized nutrition counseling, such as the sessions provided by a Registered Dietitian, plays a crucial role in TBI recovery by addressing specific dietary needs that can enhance brain function, support overall health, and improve outcomes. Personalized dietary guidance helps manage chronic conditions like diabetes and obesity, which are common in TBI patients, thereby optimizing their recovery and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications, rehabilitation therapies, and nutritional counseling. Medications such as pain relievers, anti-seizure drugs, and antidepressants can have side effects like dizziness, drowsiness, and gastrointestinal issues. Rehabilitation therapies, including physical, occupational, and speech therapy, generally have minimal side effects but can sometimes lead to fatigue or muscle soreness. Individualized Nutrition Counseling Sessions, which involve personalized dietary guidance from a Registered Dietitian, are generally safe and aim to improve overall health and recovery. Potential side effects are minimal but may include temporary digestive discomfort as dietary changes are implemented.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Traumatic Brain Injury (TBI) that focus on personalized dietary guidance and support from a Registered Dietitian. Most FDA-approved treatments for TBI are aimed at managing symptoms and preventing complications, such as medications for pain, seizures, and spasticity. The trial studying individualized nutrition counseling sessions is unique in its approach, emphasizing the potential benefits of personalized dietary guidance for individuals recovering from brain injury.

What other types of research exist?

Promising novel alternatives to individualized nutrition counseling sessions for TBI patients include telehealth nutrition sessions, which provide remote dietary guidance and support, and the use of digital self-help interventions such as smartphone applications for self-monitoring dietary intake and behavior. These alternatives leverage technology to offer accessible and scalable nutrition support.

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Behavioral Intervention

Telehealth Nutrition Sessions for Brain Injury (HOME Trial)

Phase 2

Recruiting

Led By Joy W Douglas, PhD

Research Sponsored by University of Alabama, Tuscaloosa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and approximately 6 weeks later

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves only nutritional counseling and education, there are no direct medical side effects expected from participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and approximately 6 weeks later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and approximately 6 weeks later

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and approximately 6 weeks later for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Diet Quality

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Medical Nutrition TherapyExperimental Treatment1 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 PacketActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medical Nutrition Therapy

2015

N/A

~50

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Traumatic Brain Injury (TBI) include medical management to reduce intracranial pressure, surgical interventions to remove hematomas, and rehabilitation therapies to improve cognitive and physical function. The mechanisms of action for these treatments involve stabilizing the patient, preventing secondary brain injury, and promoting recovery through targeted therapies. Individualized nutrition counseling, such as the sessions provided by a Registered Dietitian, plays a crucial role in TBI recovery by addressing specific dietary needs that can enhance brain function, support overall health, and improve outcomes. Personalized dietary guidance helps manage chronic conditions like diabetes and obesity, which are common in TBI patients, thereby optimizing their recovery and quality of life.

The impact of hypercarbia on the evolution of brain injury in a porcine model of traumatic brain injury and systemic hemorrhage.

Find a Location

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor

46 Previous Clinical Trials

19,506 Total Patients Enrolled

Academy of Nutrition and DieteticsOTHER

24 Previous Clinical Trials

5,431 Total Patients Enrolled

Joy W Douglas, PhDPrincipal InvestigatorThe University of Alabama

Media Library

Medical Nutrition Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05965947 — Phase 2

Traumatic Brain Injury Research Study Groups: Nutrition Handout Packet, Medical Nutrition Therapy

Traumatic Brain Injury Clinical Trial 2023: Medical Nutrition Therapy Highlights & Side Effects. Trial Name: NCT05965947 — Phase 2

Medical Nutrition Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965947 — Phase 2

~60 spots leftby Sep 2025

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