<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/NCT02223728</url>
  </required_header>
  <id_info>
    <org_study_id>H133A120096</org_study_id>
    <secondary_id>H133A120096</secondary_id>
    <nct_id>NCT02223728</nct_id>
  </id_info>
  <brief_title>Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury</brief_title>
  <acronym>ProjectLIFT</acronym>
  <official_title>Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Department of Education</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interventions to help individuals with traumatic brain injury manage their healthy lifestyle&#xD;
      behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a&#xD;
      telehealth lifestyle program on reductions in weight and improvements in health&#xD;
      behaviors/lifestyle choices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (BMI) scores</measure>
    <time_frame>Changes in baseline and post-program BMI scores at 7-months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Treatment Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telehealth Lifestyle Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control Condition</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Health Education Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle</intervention_name>
    <arm_group_label>Treatment Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education</intervention_name>
    <arm_group_label>Attention Control Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 19 years or older&#xD;
&#xD;
          2. English speaking&#xD;
&#xD;
          3. sustained a moderate or severe TBI (as defined by a period of confusion after the&#xD;
             injury of more than 24 hours)&#xD;
&#xD;
          4. overweight or obese as defined by a BMI score of ≥ 25 kg/m2&#xD;
&#xD;
          5. 1-year or greater post-injury&#xD;
&#xD;
          6. not currently enrolled in a weight loss program or receiving weight loss medication&#xD;
&#xD;
          7. regular access to a computer/laptop with internet capability which allows internet and&#xD;
             telephone access simultaneously&#xD;
&#xD;
          8. if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare&#xD;
             meals independently, he or she must have a non-paid, study partner willing to&#xD;
             participate in the study.&#xD;
&#xD;
        Exclusion Criteria:1&#xD;
&#xD;
          1. pregnant or planning to become pregnant in the next 7 months&#xD;
&#xD;
          2. concurrent medical condition for which changes in exercise or diet would be&#xD;
             contraindicated&#xD;
&#xD;
          3. severe hearing or visual impairment&#xD;
&#xD;
          4. significant psychiatric disorder, such as schizophrenia or bipolar disorder (those&#xD;
             with depression or anxiety will not be excluded)&#xD;
&#xD;
          5. unable to communicate&#xD;
&#xD;
          6. significant cognitive impairment and without a study partner, and/or&#xD;
&#xD;
          7. person with TBI who does not cook, shop, and/or prepare meals independently who does&#xD;
             not have a non-paid, study partner willing to participate in the study&#xD;
&#xD;
          8. currently enrolled in an organized weight loss program&#xD;
&#xD;
          9. has lost &gt; 10% of body weight over the past 6 months&#xD;
&#xD;
         10. history of an eating disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Dreer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham/Spain Rehabilitation Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Laura E. Dreer, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02223728
org study id: H133A120096
secondary id: H133A120096
nct id: NCT02223728
lead sponsor: 
collaborator: 
has dmc: Yes
Interventions to help individuals with traumatic brain injury manage their healthy lifestyle
      behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a
      telehealth lifestyle program on reductions in weight and improvements in health
      behaviors/lifestyle choices.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Body Mass Index (BMI) scores
time frame: Changes in baseline and post-program BMI scores at 7-months
arm group label: Treatment Condition
arm group type: Experimental
description: Telehealth Lifestyle Program
arm group label: Attention Control Condition
arm group type: Sham Comparator
description: Health Education Program
intervention type: Behavioral
intervention name: Lifestyle
arm group label: Treatment Condition
intervention type: Behavioral
intervention name: Health Education
arm group label: Attention Control Condition
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Dreer, Ph.D.
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laura E. Dreer, PhD
investigator title: Assistant Professor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries