<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/NCT03266666</url>
  </required_header>
  <id_info>
    <org_study_id>741</org_study_id>
    <nct_id>NCT03266666</nct_id>
  </id_info>
  <brief_title>Welcome to WellnessRX: Steps Toward a Healthier Life!</brief_title>
  <acronym>WellnessRX</acronym>
  <official_title>An Evaluation of Lifestyle Change Classes and Grocery Credits to Promote Healthy Behavior Change</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ProofPilot</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Coast Opportunities, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thrive Market</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Adventist Health Clear Lake</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ProofPilot</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>
      Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake&#xD;
      County at all levels of health including those struggling with chronic disease. The classes&#xD;
      are running across the community at all times. It is designed for patients that could benefit&#xD;
      from healthy diet, exercise, and other healthy lifestyle modifications.&#xD;
&#xD;
      For those participants attending the classes, they have the option of engaging in this&#xD;
      evaluation. For those that do, participants will answer questions about their current&#xD;
      lifestyle, their and their previous history. They will register attendance at each class and&#xD;
      answer questions about their perception of the class. Then at 45 days and 90 days the&#xD;
      participants will revisit the same baseline lifestyle questionnaires.&#xD;
&#xD;
      As participants attend classes, and complete questionnaires, they'll unlock grocery credits&#xD;
      from online food store ThriveMarket, a basket of fresh produce from the local farmers market&#xD;
      and local fitness classes to help you towards your goals. The use of these credits will be&#xD;
      tracked through the 90-day point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Activity Questionnaire with Eating Behaviors</measure>
    <time_frame>45 day</time_frame>
    <description>Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity Questionnaire with Eating Behaviors</measure>
    <time_frame>90 day</time_frame>
    <description>Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thrive Market Purchase Decisions</measure>
    <time_frame>through 90 days</time_frame>
    <description>An analysis of purchase decisions by study participants on Thrive Market, the online natural goods store.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Customer Satisfaction</measure>
    <time_frame>within 45 minutes</time_frame>
    <description>Participant perceptions of usefulness and quality of WellnessRX classes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Life Style</condition>
  <condition>Behavior</condition>
  <condition>Food Habits</condition>
  <condition>Stress</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Intervention Arm - WellnessRX</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a longitudinal outcome study. All participants will receive the class and grocery credit intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WellnessRX Lifestyle Change Classes</intervention_name>
    <description>Lifestyle change classes on nutrition, physical activity, and stress management.</description>
    <arm_group_label>Intervention Arm - WellnessRX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thrive Market Grocery Credits (4x$25 each)</intervention_name>
    <description>Thrive Market is an online grocery service available nationwide. Participants will be provided with up to $100 on grocery credits.</description>
    <arm_group_label>Intervention Arm - WellnessRX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lake County, California Resident&#xD;
&#xD;
          -  able to attend 6 lifestyle change classes held around the community&#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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>grocery</keyword>
  <keyword>lifestyle</keyword>
  <keyword>lifestyle change</keyword>
  <keyword>behavior</keyword>
  <keyword>nutrition</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03266666
org study id: 741
nct id: NCT03266666
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Wellness Rx is a 6 class prescription for a healthier lifestyle developed for people in Lake
      County at all levels of health including those struggling with chronic disease. The classes
      are running across the community at all times. It is designed for patients that could benefit
      from healthy diet, exercise, and other healthy lifestyle modifications.

      For those participants attending the classes, they have the option of engaging in this
      evaluation. For those that do, participants will answer questions about their current
      lifestyle, their and their previous history. They will register attendance at each class and
      answer questions about their perception of the class. Then at 45 days and 90 days the
      participants will revisit the same baseline lifestyle questionnaires.

      As participants attend classes, and complete questionnaires, they'll unlock grocery credits
      from online food store ThriveMarket, a basket of fresh produce from the local farmers market
      and local fitness classes to help you towards your goals. The use of these credits will be
      tracked through the 90-day point.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Activity Questionnaire with Eating Behaviors
time frame: 45 day
description: Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.
measure: Activity Questionnaire with Eating Behaviors
time frame: 90 day
description: Based on the UK National Health Service Assessments, a measure of physical activity, diet and general healthy lifestyle activities.
measure: Thrive Market Purchase Decisions
time frame: through 90 days
description: An analysis of purchase decisions by study participants on Thrive Market, the online natural goods store.
measure: Customer Satisfaction
time frame: within 45 minutes
description: Participant perceptions of usefulness and quality of WellnessRX classes
arm group label: Intervention Arm - WellnessRX
arm group type: Other
description: This is a longitudinal outcome study. All participants will receive the class and grocery credit intervention.
intervention type: Behavioral
intervention name: WellnessRX Lifestyle Change Classes
description: Lifestyle change classes on nutrition, physical activity, and stress management.
arm group label: Intervention Arm - WellnessRX
intervention type: Other
intervention name: Thrive Market Grocery Credits (4x$25 each)
description: Thrive Market is an online grocery service available nationwide. Participants will be provided with up to $100 on grocery credits.
arm group label: Intervention Arm - WellnessRX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Undecided