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

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
University of Alabama, Tuscaloosa
Study ID
NCT05965947
Status
Recruiting
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Conditions

  • Brain Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medical Nutrition Therapy — BEHAVIORAL
    One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Dec 2024
Primary completion
Oct 1, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Medical Nutrition Therapy
    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.
  • No Intervention: Nutrition Handout Packet
    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.

Primary Outcome Measure

Change in Diet Quality [ Time Frame: Baseline and approximately 6 weeks later ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of AlabamaTuscaloosaAlabama35487
Joy W Douglas, PhD
[email protected]
205-348-8044
Linda L Knol, PhD
[email protected]
2053488129

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By research site
The University of Alabama· Tuscaloosa, AL

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