Recruiting

Observational Study

Sponsor:

University of Alabama, Tuscaloosa

Code:

NCT05965947

Conditions

Brain Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medical Nutrition Therapy

Study Details

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.

Conditions

Brain Injuries

Study ID

NCT05965947

Start date

Jun 12, 2023

Status verified date

Dec, 2024

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

134 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

Medical Nutrition Therapy

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

Primary outcome measure

  • Change in Diet Quality [ Time Frame: Baseline and approximately 6 weeks later ]

Central Contacts and Locations

Central contacts

Joy W Douglas, PhD

2053488044jdouglas@ches.ua.edu

Linda L Knol, PhD

2053488129lknol@ches.ua.edu

Locations

The University of Alabama

Recruiting

Tuscaloosa, Alabama, United States, 35487

Contacts

Joy W Douglas, PhD

205-348-8044jdouglas@ches.ua.edu

Linda L Knol, PhD

2053488129lknol@ches.ua.edu

More Information

Sponsor

University of Alabama, Tuscaloosa

Last update posted

Dec 9, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama, Tuscaloosa on 2024-12-09.