Brain InjuriesHOMENCT05965947
The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury
A study testing Medical Nutrition Therapy in people with Brain Injuries, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Medical Nutrition Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama
Tuscaloosa, Alabama, 35487
Joy W Douglas, PhD, 205-348-8044, jdouglas@ches.ua.edu
Linda L Knol, PhD, 2053488129, lknol@ches.ua.edu
About this study
Official title: 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
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.
Read more
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.
Read the 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).
- Conditions
- Brain Injuries
- Being tested
- Medical Nutrition Therapy
- Keywords
- brain injury, Medical Nutrition Therapy, Registered Dietitian, diet quality, Healthy Eating Index
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Nutrition TherapyBehavioural
Also called nutrition therapy, nutrition counseling, nutrition education
One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start12 Jun 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with an intervention group and a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Sponsor
- Investigators
- Joy W Douglas, PhD, Principal investigator, The University of AlabamaLinda L Knol, PhD, Principal investigator, The University of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965947
- Sponsor's protocol ID
- 22-11-6135
- Acronym
- HOME
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05965947
- Acronym / sponsor ID
- HOME / 22-11-6135
- Conditions
- Brain Injuries
- Keywords
- brain injury, Medical Nutrition Therapy, Registered Dietitian, diet quality, Healthy Eating Index
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with an intervention group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Medical Nutrition Therapy | Experimental | Behavioral: Medical Nutrition TherapyThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Nutrition TherapyAlso: nutrition therapy, nutrition counseling, nutrition educationOne-on-one nutrition assessment, education, and counseling with a Registered Dietitian. | Behavioural | Medical Nutrition Therapy |
Primary outcome
Change in Diet Quality
Time frame: Baseline and approximately 6 weeks later
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joy W Douglas, PhD principal investigator
The University of Alabama
Linda L Knol, PhD principal investigator
The University of Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Nutrition Therapy in people with Brain Injuries, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy W Douglas, PhD (2053488044, jdouglas@ches.ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diet Quality (time frame: Baseline and approximately 6 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.