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

Brain Injuries Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965947
• Other study ID #: 22-11-6135
• Status: Recruiting
• Phase: Phase 2
• Start date: June 12, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: University of Alabama, Tuscaloosa
• Contact: Joy W Douglas, PhD
• Phone: 2053488044
• Email: jdouglas[@]ches.ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Medical Nutrition Therapy
One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.

Locations

Country	Name	City	State
United States	The University of Alabama	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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