NCT05965947 The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury
| NCT ID | NCT05965947 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama, Tuscaloosa |
| Condition | Brain Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2023-06-12 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Brain injury is a leading cause of disability in the United States. When survivors of brain injury recover from the initial injury and return home to live in the community, they often face chronic health conditions that warrant nutrition therapy, such as diabetes, high blood pressure, high cholesterol, and overweight and obesity. Typically, these individuals do not receive nutrition counseling. Thus, the purpose of this clinical trial is to compare changes in diet quality between community-dwelling individuals with a history of brain injury who receive three individualized nutrition therapy sessions versus handouts only. Our research question is: Can nutrition counseling improve dietary intake among this population? Participants will complete a survey, participate in three days of dietary recalls via Zoom or telephone, and receive either three individualized nutrition counseling sessions with a Registered Dietitian or standard of care (handouts). Researchers will compare the diets of the recipients of the nutrition counseling to a control group who receives nutrition handouts to see if nutrition sessions with a Registered Dietitian improve dietary intake.
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age * History of brain injury * Live in Alabama * Live at home in the community * Have internet access to join Zoom sessions Exclusion Criteria: * Under 18 years of age * No history of brain injury * Lives outside of Alabama * Currently in a hospital, rehabilitation facility, group home, or other location other than 'home' * Pregnant or breastfeeding * Not able/willing to participate based on the Decision-Making Capacity Assessment
Contact & Investigator
Joy W Douglas, PhD
PRINCIPAL INVESTIGATOR
The University of Alabama
Frequently Asked Questions
Who can join the NCT05965947 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05965947 currently recruiting?
Yes, NCT05965947 is actively recruiting participants. Contact the research team at jdouglas@ches.ua.edu for enrollment information.
Where is the NCT05965947 trial being conducted?
This trial is being conducted at Tuscaloosa, United States.
Who is sponsoring the NCT05965947 clinical trial?
NCT05965947 is sponsored by University of Alabama, Tuscaloosa. The principal investigator is Joy W Douglas, PhD at The University of Alabama. The trial plans to enroll 134 participants.