<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/NCT03272555</url>
  </required_header>
  <id_info>
    <org_study_id>365</org_study_id>
    <nct_id>NCT03272555</nct_id>
  </id_info>
  <brief_title>WILD 5 Wellness: A 30-Day Intervention</brief_title>
  <official_title>WILD 5 Wellness: A 30-Day Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beloit College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beloit College</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the efficacy and feasibility of an integrated,&#xD;
      prescriptive, and trackable wellness intervention combining five wellness elements including&#xD;
      exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit&#xD;
      College students self-selected into a wellness focused first year initiative.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to explore the efficacy and feasibility of an integrated,&#xD;
      prescriptive, and trackable wellness intervention combining five wellness elements including&#xD;
      exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit&#xD;
      College students self-selected into a wellness focused first year initiative. This program is&#xD;
      called &quot;WILD 5 Wellness: A 30-Day Intervention&quot;. Results for this study will be quantified&#xD;
      through the use of standardized self-report questionnaires administered prior to and after&#xD;
      students complete the WILD 5 program. Data will be collected to evaluate participants'&#xD;
      adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention.&#xD;
      It is expected that this 30-day integrated, prescriptive, and trackable program will be found&#xD;
      to be an efficacious wellness intervention for First Year Beloit College students.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Failed study, participants showed no improvements&#xD;
  </why_stopped>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">October 13, 2017</completion_date>
  <primary_completion_date type="Actual">October 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)</time_frame>
    <description>PHQ-9 is a self reported depression scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)</time_frame>
    <description>GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in The HERO Wellness Scale</measure>
    <time_frame>Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)</time_frame>
    <description>The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in World Health Organization-5 (WHO-5)</measure>
    <time_frame>Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)</time_frame>
    <description>WHO-5 is a brief scale that measures mental well-bring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Cognitive and Physical Functioning Questionnaire (CPFQ)</measure>
    <time_frame>Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)</time_frame>
    <description>CPFQ is a brief scale that measures cognitive and executive dysfunction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Post-Program Participant Questionnaire</measure>
    <time_frame>Day 31+/- 5 days</time_frame>
    <description>The Post-Program Participant Questionnaire is a brief survey that captures participants' opinions about WILD 5 Wellness: A 30-Day Intervention, and subjective ranking of their overall wellness.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Wellness</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <condition>Cognitive and Executive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Study Participants</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participants in this arm will engage in the WILD 5 Wellness activities combining five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WILD 5 Wellness Interventions</intervention_name>
    <description>Students enrolled in the study will be asked to complete activities in five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition for 30 days.</description>
    <arm_group_label>Study Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  students 18 years of age or older&#xD;
&#xD;
          -  students enrolled in First Year Initiative Course titled, &quot;Habits of Mind, Habits of&#xD;
             Body.&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals who are pregnant or plan to get pregnant during the next 30 days&#xD;
&#xD;
          -  students who are not enrolled in the First Year Initiative Course titled, &quot;Habits of&#xD;
             Mind, Habits of Body&quot;.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beloit College</name>
      <address>
        <city>Beloit</city>
        <state>Wisconsin</state>
        <zip>53511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT03272555
org study id: 365
nct id: NCT03272555
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the efficacy and feasibility of an integrated,
      prescriptive, and trackable wellness intervention combining five wellness elements including
      exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit
      College students self-selected into a wellness focused first year initiative.
The purpose of this study is to explore the efficacy and feasibility of an integrated,
      prescriptive, and trackable wellness intervention combining five wellness elements including
      exercise, mindfulness, sleep, social connectedness, and nutrition in First Year Beloit
      College students self-selected into a wellness focused first year initiative. This program is
      called "WILD 5 Wellness: A 30-Day Intervention". Results for this study will be quantified
      through the use of standardized self-report questionnaires administered prior to and after
      students complete the WILD 5 program. Data will be collected to evaluate participants'
      adherence and response to each element of WILD 5, a 5-pronged 30-day wellness intervention.
      It is expected that this 30-day integrated, prescriptive, and trackable program will be found
      to be an efficacious wellness intervention for First Year Beloit College students.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
time frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
description: PHQ-9 is a self reported depression scale.
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
time frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
description: GAD-7 is a self-reported questionnaire used to assess anxiety symptoms.
measure: Change in The HERO Wellness Scale
time frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
description: The HERO Wellness Scale is a brief scale designed to measure mental wellness specifically happiness, enthusiasm, resilience and optimism.
measure: Change in World Health Organization-5 (WHO-5)
time frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
description: WHO-5 is a brief scale that measures mental well-bring.
measure: Change in Cognitive and Physical Functioning Questionnaire (CPFQ)
time frame: Day 0, Day 31+/- 5 days, Day 30+6 months (approximately)
description: CPFQ is a brief scale that measures cognitive and executive dysfunction.
measure: The Post-Program Participant Questionnaire
time frame: Day 31+/- 5 days
description: The Post-Program Participant Questionnaire is a brief survey that captures participants' opinions about WILD 5 Wellness: A 30-Day Intervention, and subjective ranking of their overall wellness.
arm group label: Study Participants
arm group type: Other
description: The participants in this arm will engage in the WILD 5 Wellness activities combining five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition.
intervention type: Other
intervention name: WILD 5 Wellness Interventions
description: Students enrolled in the study will be asked to complete activities in five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition for 30 days.
arm group label: Study Participants
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression