<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/NCT03027518</url>
  </required_header>
  <id_info>
    <org_study_id>302</org_study_id>
    <nct_id>NCT03027518</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 Beloit College students.&#xD;
      This program is called &quot;WILD 5 Wellness: A 30-Day Intervention&quot;. Results for this study will&#xD;
      be quantified through the use of standardized self-report questionnaires administered prior&#xD;
      to and after students complete the WILD 5 program (Group 1) or 30 days of inactive&#xD;
      participation (Group 2), and again approximately 30 days later when the initially inactive&#xD;
      group (Group 2) will have just completed their active participation in the WILD 5 program and&#xD;
      the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their&#xD;
      WILD 5 active portion. Data will be collected to evaluate participants' adherence and&#xD;
      response to each element of WILD 5, a 5-pronged 30-day wellness intervention. It is expected&#xD;
      that this 30-day integrated, prescriptive, and trackable program will be found to be an&#xD;
      efficacious wellness intervention for Beloit College students as compared to the control&#xD;
      (inactive) group of students not participating in the Active program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">December 5, 2017</completion_date>
  <primary_completion_date type="Actual">April 18, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WILD 5 Wellness Scale (W5WS), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>WILD 5 Wellness Elements (W5WE), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>WILD 5 Wellness Effort Scale (W5WES), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>WHO (World Health Organization) 5 Well-Being Index (1998 version), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Connectedness Scale (SCS), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Condition Indicator (SCI), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Sheehan Disability Scale (SDS), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS), Day to Day Experiences, Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MIND ( Mediterranean-DASH Intervention for Neurodegenerative Delay)Diet, Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder (GAD-7), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Eating and Appraisal Due to Emotions and Stress Questionnaire (EADES), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive and Physical Functioning Questionnaire (CPFQ), Assessing Change</measure>
    <time_frame>Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Program Participant Questionnaire</measure>
    <time_frame>The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 1 will be active in the WILD 5 Wellness program the first 30 days and inactive the 2nd 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 2 will be inactive in the WILD 5 Wellness program the first 30 days and active the 2nd 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WILD 5 Wellness</intervention_name>
    <description>Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Beloit College student enrolled in one or more of the following Spring 2017 academic&#xD;
             courses:&#xD;
&#xD;
          -  Anthropology 201 01 &quot;Research Designs: Sophomore Seminar in Anthropology&quot;&#xD;
&#xD;
          -  Health and Society 240 B1 &quot;Sophomore Seminar in Health and Society&quot;&#xD;
&#xD;
          -  Spanish 218 &quot;Health and Culture in the Spanish-Speaking World&quot;&#xD;
&#xD;
          -  Biology 373 &quot;Neuroscience Research&quot;&#xD;
&#xD;
          -  Biology 215 &quot;Emerging Diseases&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are &lt;18 years old&#xD;
&#xD;
          -  Individuals who are acutely suicidal and/or actively psychotic&#xD;
&#xD;
          -  Individuals who are pregnant or plan to get pregnant during the next 60 days, or who&#xD;
             are not registered in one of the courses listed above.&#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>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 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>
  <!-- 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/NCT03027518
org study id: 302
nct id: NCT03027518
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 Beloit College students.
      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 (Group 1) or 30 days of inactive
      participation (Group 2), and again approximately 30 days later when the initially inactive
      group (Group 2) will have just completed their active participation in the WILD 5 program and
      the first WILD 5 group (Group 1) will be approximately 30 days out from completion of their
      WILD 5 active portion. 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 Beloit College students as compared to the control
      (inactive) group of students not participating in the Active program.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: WILD 5 Wellness Scale (W5WS), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: WILD 5 Wellness Elements (W5WE), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: WILD 5 Wellness Effort Scale (W5WES), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: WHO (World Health Organization) 5 Well-Being Index (1998 version), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Social Connectedness Scale (SCS), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Sleep Condition Indicator (SCI), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Sheehan Disability Scale (SDS), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Patient Health Questionnaire (PHQ-9), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Mindful Attention Awareness Scale (MAAS), Day to Day Experiences, Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: MIND ( Mediterranean-DASH Intervention for Neurodegenerative Delay)Diet, Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Generalized Anxiety Disorder (GAD-7), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Eating and Appraisal Due to Emotions and Stress Questionnaire (EADES), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Cognitive and Physical Functioning Questionnaire (CPFQ), Assessing Change
time frame: Day 0, Day 30, Day 60, Day 30 + 6 months (Group 1), Day 60 + 6 months (Group 2)
measure: Post Program Participant Questionnaire
time frame: The end of the 30 day active participation in WILD 5 Wellness for each group (1 and 2)
arm group label: Group 1
arm group type: Other
description: Group 1 will be active in the WILD 5 Wellness program the first 30 days and inactive the 2nd 30 days.
arm group label: Group 2
arm group type: Other
description: Group 2 will be inactive in the WILD 5 Wellness program the first 30 days and active the 2nd 30 days.
intervention type: Other
intervention name: WILD 5 Wellness
description: Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor