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

Medical Nutrition Therapy and Diet Quality Among Survivors of Brain Injury - The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05965947
Acronym
HOME
Enrollment
134
Registered
2023-07-28
Start date
2023-06-12
Completion date
2025-10-31
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

Keywords

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

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.

Detailed description

The purpose of this study is to evaluate the impact of providing nutrition therapy on diet among a cohort of community-dwelling individuals with a history of brain injury. In this pre/post study, 134 participants with brain injury will be recruited and randomized to the control or intervention group. All participants will complete a standard set of nutrition-related questionnaires to assess weight status, co-morbid conditions, food security, stressors, stress-related eating, eating behaviors, and diet quality. The control group will receive a packet of nutrition education materials. The intervention group will receive the packet and one-on-one nutrition counseling with a Registered Dietitian. Follow-up data collection will include repeating the dietary recalls and questionnaires. This will allow for an evaluation of the impact of nutrition therapy on diet quality among community-dwelling individuals with brain injury. Aim: Evaluate the effectiveness of providing nutrition therapy on diet quality and stress-related eating among a cohort of community-dwelling individuals with brain injury • Ho: Individuals who receive three nutrition therapy sessions with a Registered Dietitian will have greater increases in Healthy Eating Index (HEI) scores than those who receive only handouts (current practice).

Interventions

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

Sponsors

Academy of Nutrition and Dietetics
CollaboratorOTHER
University of Alabama, Tuscaloosa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor will be blinded to the group assignment of participants.

Intervention model description

Randomized controlled trial with an intervention group and a control group.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Diet QualityBaseline and approximately 6 weeks laterDiet 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.

Countries

United States

Contacts

Primary ContactJoy W Douglas, PhD
jdouglas@ches.ua.edu2053488044
Backup ContactLinda L Knol, PhD
lknol@ches.ua.edu2053488129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026