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

NCT05965947 | Recruiting DMC

• 1 other identifier: 22-11-6135
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Keywords

brain injury; Medical Nutrition Therapy; Registered Dietitian; diet quality; Healthy Eating Index

Outcome Measures

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.

  Baseline and approximately 6 weeks later

Study Arms (2)

Medical Nutrition Therapy

EXPERIMENTAL

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.

Behavioral: Medical Nutrition Therapy

Nutrition Handout Packet

NO 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.

Interventions

Medical Nutrition Therapy BEHAVIORAL

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

Also known as: nutrition therapy, nutrition counseling, nutrition education

Medical Nutrition Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

The University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Interventions

Nutrition Therapy; Nutrition Assessment

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Joy W Douglas, PhD

  The University of Alabama

  PRINCIPAL INVESTIGATOR

• Linda L Knol, PhD

  The University of Alabama

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy W Douglas, PhD

CONTACT

2053488044; jdouglas@ches.ua.edu

Linda L Knol, PhD

CONTACT

2053488129; lknol@ches.ua.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to the group assignment of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with an intervention group and a control group.

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 28, 2023
• Study Start: June 12, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)