Clinical Trial

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

Study acronym: HOME
Recruiting
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Record status
This record was last updated December 9, 2024 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-07-25.
Trial Details
NCT Number NCT05965947
Lead Sponsor University of Alabama, Tuscaloosa
Collaborators: Academy of Nutrition and Dietetics
Conditions Brain Injuries
Enrollment 134 participants
Start Date 2023-06-12
Primary Completion 2025-10-01 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-09