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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama, Tuscaloosa

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

History of brain injury

Live in Alabama

Live at home in the community

Disqualifiers

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'

Trial design

Design model

Parallel

Treatments tested in this trial

  • Medical Nutrition Therapy

    Behavioral

    One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Medical Nutrition TherapyExperimental treatment 1 intervention
Group B: Nutrition Handout PacketNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Diet Quality

Diet quality is measured using the Healthy Eating Index Score, which ranges from 0-100. Higher scores indicate better diet quality. The score will be calculated at baseline and approximately 6 weeks later, and these timepoints will be used to calculate the change in diet quality over the study duration.

Time frame
Baseline and approximately 6 weeks later

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama, Tuscaloosa

Lead sponsor

Academy of Nutrition and Dietetics

Collaborator