The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury
NCT ID: NCT05965947
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2023-06-12
2025-10-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Medical Nutrition Therapy
One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.
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.
No interventions assigned to this group
Interventions
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Medical Nutrition Therapy
One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of brain injury
* Live in Alabama
* Live at home in the community
* Have internet access to join Zoom sessions
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Academy of Nutrition and Dietetics
OTHER
University of Alabama, Tuscaloosa
OTHER
Responsible Party
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Principal Investigators
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Joy W Douglas, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama
Linda L Knol, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama
Locations
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The University of Alabama
Tuscaloosa, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Joy W Douglas, PhD
Role: primary
Linda L Knol, PhD
Role: backup
Other Identifiers
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22-11-6135
Identifier Type: -
Identifier Source: org_study_id