<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/NCT02196012</url>
  </required_header>
  <id_info>
    <org_study_id>9271B</org_study_id>
    <nct_id>NCT02196012</nct_id>
  </id_info>
  <brief_title>A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students</brief_title>
  <official_title>&quot;The UTK Health Study&quot; A Technology-Based Weight Loss Intervention for the Reduction of Overweight and Obesity Among College Students.&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Tennessee, Knoxville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Tennessee, Knoxville</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the feasibility and acceptability and efficacy of a&#xD;
      two month technology-based weight loss program for overweight and obese college students.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial design will be employed to investigate the effectiveness,&#xD;
      feasibility, and acceptability of a technology-based weight loss pilot intervention for the&#xD;
      reduction of overweight and obesity in college students. Participants will be randomly&#xD;
      assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention&#xD;
      control group. Both conditions include 8 weekly lessons over 8 weeks. Undergraduate students&#xD;
      (n=100) age 18-22 years who are overweight or obese (BMI ≥ 25 kg/m2) will be recruited from&#xD;
      the University of Tennessee Knoxville. Measurements will be taken at baseline and 8 weeks.&#xD;
      Since the study is a technology-based intervention, research staff will collect height and&#xD;
      weight measures for BMI through a novel approach, utilizing Skype video conferencing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>body mass index (BMI)</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>feasibility</measure>
    <time_frame>2 months</time_frame>
    <description>A mixed methods approach, including online surveys and focus groups, was employed to assess the feasibility of the pilot study. Feasibility was assessed through recruitment and retention data and self-reported records of participant engagement.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>acceptability</measure>
    <time_frame>2 months</time_frame>
    <description>Participants in both groups completed an online post-intervention survey. Data were collected and compiled through SurveyMonkey. Surveys were comprised of a combination of closed-ended and open-ended questions. Participants completed text-based focus group using Skype group messaging. Participants were asked to provide feedback on each technology tool in the program, the website, methods of delivery, the duration of the program, and the overall program. A benefit was that the online tools allowed students to maintain anonymity, which could have encouraged participation and sharing.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention condition will contain multiple components: nutrition education, physical activity, social support, social media (Pinterest and Facebook), and smartphone applications for self-monitoring. Students in this condition will have access to the private study website, which will be the central platform for delivery of the program materials and social support. The website, developed using Wordpress.com, will include nutrition materials, exercise videos, a forum, and links to the study's Facebook and Pinterest pages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>attention control condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Students randomized to the attention control condition will receive educational emails three times per week. Nutrition materials will be sent once a week, and links to the YouTube exercise videos will be sent twice a week. At the start of the program, students will be emailed a link to the Pandora workout station. The materials sent to the control group will be the same materials posted on the website for the intervention group. Participants will access the emailed lessons and videos each week at their own convenience. Individuals in the attention control condition will not have access to the study website or social media pages.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <arm_group_label>Lifestyle counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>attention control condition</intervention_name>
    <arm_group_label>attention control condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligibility will include UTK undergraduate students who are overweight or obese (BMI ≥&#xD;
             25 kg/m2) and between 18-22 years of age, with access to the Internet, a personal&#xD;
             computer (laptop, tablet, or desktop computer), and a smartphone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any individual who does not meet all the inclusion criteria will be excluded from&#xD;
             participation in the study.&#xD;
&#xD;
          -  Students who have a medical condition that precludes adherence to dietary&#xD;
             recommendations&#xD;
&#xD;
          -  Who are currently prescribed medications that may impact weight, or who are currently&#xD;
             participating in or planning to participate in another weight loss programs in the&#xD;
             next six months&#xD;
&#xD;
          -  Who have been diagnosed with a major psychiatric illness (e.g., bipolar disorder,&#xD;
             schizophrenia, or depression) within the last 12 months&#xD;
&#xD;
          -  Who are pregnant or plan to become pregnant in the next six months&#xD;
&#xD;
          -  Who have given birth within the last six months&#xD;
&#xD;
          -  Who have been diagnosed with any type of eating disorder within the past 12 months&#xD;
             will be ineligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Tennessee</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37996</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>April 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>overweight</keyword>
  <keyword>obesity</keyword>
  <keyword>Technology</keyword>
  <keyword>College Students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</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/NCT02196012
org study id: 9271B
nct id: NCT02196012
lead sponsor: 
has dmc: No
The purpose of this study is to determine the feasibility and acceptability and efficacy of a
      two month technology-based weight loss program for overweight and obese college students.
A randomized controlled trial design will be employed to investigate the effectiveness,
      feasibility, and acceptability of a technology-based weight loss pilot intervention for the
      reduction of overweight and obesity in college students. Participants will be randomly
      assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention
      control group. Both conditions include 8 weekly lessons over 8 weeks. Undergraduate students
      (n=100) age 18-22 years who are overweight or obese (BMI ≥ 25 kg/m2) will be recruited from
      the University of Tennessee Knoxville. Measurements will be taken at baseline and 8 weeks.
      Since the study is a technology-based intervention, research staff will collect height and
      weight measures for BMI through a novel approach, utilizing Skype video conferencing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: body mass index (BMI)
time frame: 2 months
measure: feasibility
time frame: 2 months
description: A mixed methods approach, including online surveys and focus groups, was employed to assess the feasibility of the pilot study. Feasibility was assessed through recruitment and retention data and self-reported records of participant engagement.
measure: acceptability
time frame: 2 months
description: Participants in both groups completed an online post-intervention survey. Data were collected and compiled through SurveyMonkey. Surveys were comprised of a combination of closed-ended and open-ended questions. Participants completed text-based focus group using Skype group messaging. Participants were asked to provide feedback on each technology tool in the program, the website, methods of delivery, the duration of the program, and the overall program. A benefit was that the online tools allowed students to maintain anonymity, which could have encouraged participation and sharing.
arm group label: Lifestyle counseling
arm group type: Experimental
description: The intervention condition will contain multiple components: nutrition education, physical activity, social support, social media (Pinterest and Facebook), and smartphone applications for self-monitoring. Students in this condition will have access to the private study website, which will be the central platform for delivery of the program materials and social support. The website, developed using Wordpress.com, will include nutrition materials, exercise videos, a forum, and links to the study's Facebook and Pinterest pages
arm group label: attention control condition
arm group type: Active Comparator
description: Students randomized to the attention control condition will receive educational emails three times per week. Nutrition materials will be sent once a week, and links to the YouTube exercise videos will be sent twice a week. At the start of the program, students will be emailed a link to the Pandora workout station. The materials sent to the control group will be the same materials posted on the website for the intervention group. Participants will access the emailed lessons and videos each week at their own convenience. Individuals in the attention control condition will not have access to the study website or social media pages.
intervention type: Behavioral
intervention name: Intervention group
arm group label: Lifestyle counseling
intervention type: Behavioral
intervention name: attention control condition
arm group label: attention control condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Overweight