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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

HOME Trial Summary

This trial aims to understand if nutrition counseling can improve the dietary intake of people with a history of brain injury. They will receive either 3 nutrition counseling sessions or nutrition handouts and their diets will be compared.

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.Check my eligibility

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.See study design

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.

HOME 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Diet Quality

HOME 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

Find a Location

Who is running the clinical trial?

University of Alabama, TuscaloosaLead Sponsor

44 Previous Clinical Trials

19,382 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this research program?

"Indications from clinicaltrials.gov suggest that this research trial is actively recruiting for participants, with the first post being made on June 12th 2023 and the most recent update occurring July 25th of the same year."

Answered by AI

What is the aggregate figure of individuals enrolled in this experiment?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical experiment is open for applicants as of now. It was first posted on June 12th 2023 and recently updated on July 25th 2023; 134 patients are required from 1 centre to fill the trial's needs."

Answered by AI

Has Medical Nutrition Therapy been endorsed by the Food and Drug Administration?

"The safety of Medical Nutrition Therapy was given a score of 2 due to the Phase 2 status, meaning there is some data attesting its safety but no evidence that it effectively treats any condition."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury

2023. "The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05965947.

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