Telehealth Nutrition Sessions for Brain Injury (HOME Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama, Tuscaloosa
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.
12345Is 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.
13678How 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.
135910Eligibility 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.Participant Groups
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.
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.
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The University of AlabamaTuscaloosa, AL
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Who is running the clinical trial?
University of Alabama, TuscaloosaLead Sponsor
Academy of Nutrition and DieteticsCollaborator
References
Recovery of malnutrition in a patient with severe brain injury outcomes: A case report. [2022]Severe brain injury often induces a state of malnutrition due to insufficient caloric and protein input. If left untreated, it will have a negative impact on rehabilitation. Nutritional therapy provides caloric and the nutritional support necessary to cover the daily needs and help contrast hospital infections. Our hypothesis is that integration of natural foods in the daily diet can enhance the recovery of the state of malnutrition and increase rehabilitation outcomes.
[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]To analyze the effect of target-oriented treatment based on nutrition-oriented information software on nutritional standards of adult patients with severe traumatic brain injury (sTBI).
Nutrition Management in Patients With Traumatic Brain Injury: A Narrative Review. [2023]Traumatic brain injury (TBI) is a major cause of long-term physical and psychological disability and death. In patients with TBI, undernutrition is associated with an increased mortality rate, more infectious complications, and worse neurologic outcomes. Therefore, timely and effective nutritional therapy is particularly crucial in the management of TBI to improve patients' prognoses. This narrative review summarizes the issues encountered in clinical practice for patients with neurotrauma who receive acute and post-acute in-patient rehabilitation services, and it comprehensively incorporates a wide range of studies, including recent clinical practice guidelines (CPGs), with the aim of better understanding the current evidence for optimal nutritional therapy focused on TBI patients. Recent CPGs were reviewed for 6 topics: 1) hypermetabolism and variation in energy expenditure in patients with TBI, 2) delayed gastric emptying and intolerance to enteral nutrition, 3) decision-making on the route and timing of access in patients with TBI who are unable to maintain volitional intake (enteral nutrition versus parenteral nutrition), 4) decision-making on the enteral formula (standard or immune-modulating formulas), 5) glycemic control, and 6) protein support. We also identified areas that need further research in the future.
Nutrition therapy in the optimisation of health outcomes in adult patients with moderate to severe traumatic brain injury: findings from a scoping review. [2014]Patients who have sustained traumatic brain injury (TBI) have increased nutritional requirements yet are often unable to eat normally, and adequate nutritional therapy is needed to optimise recovery. The aim of the current scoping review was to describe the existing evidence for improved outcomes with optimal nutrition therapy in adult patients with moderate to severe TBI, and to identify gaps in the literature to inform future research.
Malnutrition in patients with acute stroke. [2021]Stroke is a devastating event that carries a potential for long-term disability. Malnutrition is frequently observed in patients with stroke, and dysphagia contributes to malnutrition risk. During both the acute phase of stroke and rehabilitation, specific nutritional interventions in the context of a multidisciplinary team effort can enhance the recovery of neurocognitive function. Early identification and management of malnutrition with dietary modifications or specific therapeutic strategies to ensure adequate nutritional intake should receive more attention, since poor nutritional status appears to exacerbate brain damage and to contribute to adverse outcome. The main purpose of nutritional intervention should be the prevention or treatment of complications resulting from energy-protein deficit. This paper reviews the evaluation and management of malnutrition and the use of specialized nutrition support in patients with stroke. Emphasis is given to enteral tube and oral feeding and to strategies to wean from tube feeding.
Nutrition therapy in severe head trauma patients. [2022]This article reviews the literature, organizes the major findings, and generates the best evidence-based recommendations on nutrition therapy for head trauma patients. Despite recent advances in head trauma diagnosis and therapy, the mortality associated with this condition remains high. Few therapeutic interventions have been proven to effectively improve this condition. Head trauma causes multiple metabolic and electrolytic disorders; it is characterized by a hypermetabolic state that is associated with intensive catabolism, leading to specific nutritional needs. The current literature lacks specific guidelines for nutrition therapy in severe head trauma patients, although a substantial amount of data has been reported and relevant issues are currently being studied; these data may allow better nutrition therapy guidelines for these patients. In addition to a well-trained multi-disciplinary team, the following recommendations appear to improve outcomes: introducing nutrition therapy early; preferred enteral administration; appropriate energy intake; formulations that are tailored to specific patients, including appropriate nutrients; and strict electrolytic and metabolic monitoring. Understanding the pathophysiology and the consequences of therapy is fundamental.
Enteral or parenteral nutrition in traumatic brain injury: a prospective randomised trial. [2015]Few studies have evaluated the route of nutritional therapy in patients with head trauma.
Towards a Standardized Definition of Medical Nutrition Therapy and Regulatory Reform in Canada. [2022]Various definitions have been proposed to describe Medical Nutrition Therapy (MNT). Broadly, MNT encompasses the provision of nutrition information and advice aimed to prevent, treat, and/or manage health conditions. In Canada, the provision of such information and advice is unregulated, thus allowing anyone to provide MNT services regardless of their education and training. This inevitably poses risks of harm such as the provision of unsafe and/or ineffective nutrition advice as well as delayed evidence-based treatment. Canadian research has further demonstrated that the general public is unable to properly differentiate between regulated, evidence-based nutrition providers (registered dietitians) and those who are unregulated. Therefore, the public is at risk. To reduce nutrition misinformation and ultimately improve the health and well-being of the public, the objective of this paper is, first, to propose a standardized definition of MNT for use across Canada and, second, to propose province- and territory-specific legislative amendments for the regulation of MNT throughout the country. We also present an opposing perspective to the proposed viewpoint. Ultimately, health care regulation across the country requires an overhaul before we expect that nutrition information and advice communicated to the public may be consistently evidence based.
Nutritional support and head trauma. [2004]Nutritional therapy in the head-injured patient is designed to prevent catabolism of lean body cell mass; minimize specific and potential complications; and assist the patient to return to normal nutritional status. Prompt nutritional support accompanied by physical therapy can enhance long term rehabilitation. The critical care nurse plays a major role in this process by providing nutrition along with hemodynamic and neurologic stabilization.
Examining Utilization of an Outpatient Telenutrition Service Across Primary Care Clinics in South Carolina. [2023]Introduction: Limited research exists on outpatient telenutrition, and more evidence is needed on service utilization and program evaluation. This study explored service utilization trends and patterns of the Medical University of South Carolina (MUSC) Outpatient Telehealth Nutrition (OT Nutrition) service. Methods: De-identified patient service utilization data were obtained from MUSC's OT Nutrition administrative files (2012-2020). Service utilization (referrals, visits scheduled, consultations, no-shows, no-show rate) was measured at the clinic level and stratified by patient type (adult/pediatric) and clinic rurality (rural/urban). Data were analyzed using descriptive statistics and a K-means cluster analysis. Results: Service utilization (2012-2020) reflected 6,212 referrals, 3,993 visits scheduled, and 2,880 consultations across 56 clinics. Yearly utilization trends showed high variability with no statistically significant differences observed on univariate comparisons of patient type or clinic rurality. The introduction of the Direct-To-Consumer modality mitigated a 36.7% decrease in consultations during the COVID-19 pandemic in 2020. Results of a K-means cluster analysis (p < 0.001) indicated 7% (n = 4) of clinics were very high and high utilizers, 36% (n = 21) were moderate and low utilizers, and 53% (n = 31) were very low utilizers. Discussion: Telenutrition can be delivered effectively to patients without requiring travel outside patients' medical homes or residences. Although continued advocacy is necessary for South Carolina to expand telenutrition coverage, more research is needed to evaluate the OT Nutrition service. Cluster analysis is an effective tool for identifying statistically significant groupings of clinics based on service utilization and could be used with implementation science in future program evaluation.