xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05965947</url>
    </required_header>
    <id_info>
      <org_study_id>22-11-6135</org_study_id>
      <nct_id>NCT05965947</nct_id>
    </id_info>
    <brief_title>The HOME Study (Healthy Options Made Easy): Telehealth Nutrition Sessions for People Living With Brain Injury</brief_title>
    <acronym>HOME</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama, Tuscaloosa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Academy of Nutrition and Dietetics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Alabama, Tuscaloosa</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Brain injury is a leading cause of disability in the United States. When survivors of brain&#xD;
        injury recover from the initial injury and return home to live in the community, they often&#xD;
        face chronic health conditions that warrant nutrition therapy, such as diabetes, high blood&#xD;
        pressure, high cholesterol, and overweight and obesity. Typically, these individuals do not&#xD;
        receive nutrition counseling.&#xD;
  &#xD;
        Thus, the purpose of this clinical trial is to compare changes in diet quality between&#xD;
        community-dwelling individuals with a history of brain injury who receive three&#xD;
        individualized nutrition therapy sessions versus handouts only.&#xD;
  &#xD;
        Our research question is:&#xD;
  &#xD;
        Can nutrition counseling improve dietary intake among this population?&#xD;
  &#xD;
        Participants will complete a survey, participate in three days of dietary recalls via Zoom or&#xD;
        telephone, and receive either three individualized nutrition counseling sessions with a&#xD;
        Registered Dietitian or standard of care (handouts).&#xD;
  &#xD;
        Researchers will compare the diets of the recipients of the nutrition counseling to a control&#xD;
        group who receives nutrition handouts to see if nutrition sessions with a Registered&#xD;
        Dietitian improve dietary intake.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to evaluate the impact of providing nutrition therapy on diet&#xD;
        among a cohort of community-dwelling individuals with a history of brain injury.&#xD;
  &#xD;
        In this pre/post study, 134 participants with brain injury will be recruited and randomized&#xD;
        to the control or intervention group. All participants will complete a standard set of&#xD;
        nutrition-related questionnaires to assess weight status, co-morbid conditions, food&#xD;
        security, stressors, stress-related eating, eating behaviors, and diet quality.&#xD;
  &#xD;
        The control group will receive a packet of nutrition education materials. The intervention&#xD;
        group will receive the packet and one-on-one nutrition counseling with a Registered&#xD;
        Dietitian.&#xD;
  &#xD;
        Follow-up data collection will include repeating the dietary recalls and questionnaires. This&#xD;
        will allow for an evaluation of the impact of nutrition therapy on diet quality among&#xD;
        community-dwelling individuals with brain injury.&#xD;
  &#xD;
        Aim: Evaluate the effectiveness of providing nutrition therapy on diet quality and&#xD;
        stress-related eating among a cohort of community-dwelling individuals with brain injury&#xD;
  &#xD;
        • Ho: Individuals who receive three nutrition therapy sessions with a Registered Dietitian&#xD;
        will have greater increases in Healthy Eating Index (HEI) scores than those who receive only&#xD;
        handouts (current practice).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized controlled trial with an intervention group and a control group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The outcomes assessor will be blinded to the group assignment of participants.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Diet Quality</measure>
      <time_frame>Baseline and approximately 6 weeks later</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Brain Injuries</condition>
    <arm_group>
      <arm_group_label>Medical Nutrition Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutrition Handout Packet</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Medical Nutrition Therapy</intervention_name>
      <description>One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.</description>
      <arm_group_label>Medical Nutrition Therapy</arm_group_label>
      <other_name>nutrition therapy, nutrition counseling, nutrition education</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years of age&#xD;
  &#xD;
            -  History of brain injury&#xD;
  &#xD;
            -  Live in Alabama&#xD;
  &#xD;
            -  Live at home in the community&#xD;
  &#xD;
            -  Have internet access to join Zoom sessions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under 18 years of age&#xD;
  &#xD;
            -  No history of brain injury&#xD;
  &#xD;
            -  Lives outside of Alabama&#xD;
  &#xD;
            -  Currently in a hospital, rehabilitation facility, group home, or other location other&#xD;
               than 'home'&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Not able/willing to participate based on the Decision-Making Capacity Assessment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joy W Douglas, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Alabama</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Linda L Knol, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Alabama</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joy W Douglas, PhD</last_name>
      <phone>2053488044</phone>
      <email>jdouglas@ches.ua.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Linda L Knol, PhD</last_name>
      <phone>2053488129</phone>
      <email>lknol@ches.ua.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Alabama</name>
        <address>
          <city>Tuscaloosa</city>
          <state>Alabama</state>
          <zip>35487</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joy W Douglas, PhD</last_name>
        <phone>205-348-8044</phone>
        <email>jdouglas@ches.ua.edu</email>
      </contact>
      <contact_backup>
        <last_name>Linda L Knol, PhD</last_name>
        <phone>2053488129</phone>
        <email>lknol@ches.ua.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>brain injury</keyword>
    <keyword>Medical Nutrition Therapy</keyword>
    <keyword>Registered Dietitian</keyword>
    <keyword>diet quality</keyword>
    <keyword>Healthy Eating Index</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05965947
  org study id: 22-11-6135
  nct id: NCT05965947
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial with an intervention group and a control group.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The outcomes assessor will be blinded to the group assignment of participants.
  measure: Change in Diet Quality
  time frame: Baseline and approximately 6 weeks later
  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.
  arm group label: Medical Nutrition Therapy
  arm group type: Experimental
  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 group label: Nutrition Handout Packet
  arm group type: No Intervention
  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: Medical Nutrition Therapy
  description: One-on-one nutrition assessment, education, and counseling with a Registered Dietitian.
  arm group label: Medical Nutrition Therapy
  other name: nutrition therapy, nutrition counseling, nutrition education
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joy W Douglas, PhD
  role: Principal Investigator
  affiliation: The University of Alabama
  last name: Linda L Knol, PhD
  role: Principal Investigator
  affiliation: The University of Alabama
  last name: Joy W Douglas, PhD
  phone: 2053488044
  email: jdouglas@ches.ua.edu
  last name: Linda L Knol, PhD
  phone: 2053488129
  email: lknol@ches.ua.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No