search
Back to results

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

Primary Purpose

Brain Injuries

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Medical Nutrition Therapy
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring brain injury, Medical Nutrition Therapy, Registered Dietitian, diet quality, Healthy Eating Index

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of AlabamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Medical Nutrition Therapy

Nutrition Handout Packet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2023
Last Updated
July 25, 2023
Sponsor
University of Alabama, Tuscaloosa
Collaborators
Academy of Nutrition and Dietetics
search

1. Study Identification

Unique Protocol Identification Number
NCT05965947
Brief Title
The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury
Acronym
HOME
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
Academy of Nutrition and Dietetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
brain injury, Medical Nutrition Therapy, Registered Dietitian, diet quality, Healthy Eating Index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with an intervention group and a control group.
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be blinded to the group assignment of participants.
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Nutrition Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutrition Handout Packet
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medical Nutrition Therapy
Other Intervention Name(s)
nutrition therapy, nutrition counseling, nutrition education
Intervention Description
One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.
Primary Outcome Measure Information:
Title
Change in Diet Quality
Description
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.
Time Frame
Baseline and approximately 6 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy W Douglas, PhD
Phone
2053488044
Email
jdouglas@ches.ua.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda L Knol, PhD
Phone
2053488129
Email
lknol@ches.ua.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy W Douglas, PhD
Organizational Affiliation
The University of Alabama
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda L Knol, PhD
Organizational Affiliation
The University of Alabama
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy W Douglas, PhD
Phone
205-348-8044
Email
jdouglas@ches.ua.edu
First Name & Middle Initial & Last Name & Degree
Linda L Knol, PhD
Phone
2053488129
Email
lknol@ches.ua.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs