<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/NCT03308162</url>
  </required_header>
  <id_info>
    <org_study_id>2017-270</org_study_id>
    <nct_id>NCT03308162</nct_id>
  </id_info>
  <brief_title>The Kickstart Health Program</brief_title>
  <official_title>Acceptability and Feasibility of a Multicomponent Group Intervention to Initiate Health Behavior Change: The Kickstart Health Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Blue Cross Blue Shield of Michigan Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Beaumont Hospitals</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>
      This study is testing the acceptability and feasibility of an active, experiential group&#xD;
      therapy for health behavior change within a medical setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the current study is to offer a preliminary test of feasibility and&#xD;
      acceptability for a group intervention, conducted in a primary care setting, that aims to&#xD;
      teach skills that initiate health behavior change. Participants will be recruited from a&#xD;
      local family medicine clinic and groups will be held on site at the clinic. Patients will be&#xD;
      recruited by their physicians and given a baseline survey of their exercise and nutrition&#xD;
      behaviors as well as their overall well being and self efficacy to change their health&#xD;
      behaviors. Participants can join the group at any time and attend as many sessions as&#xD;
      desired. Groups are held 2 times per month and include worksheets, meditations, and exercise.&#xD;
      Patients and their providers will be given 2 follow up surveys after 5 and 13 weeks to assess&#xD;
      for acceptability and feasibility of the program, as well as health behavior change.&#xD;
      Statistical analyses will include multivariate analyses, descriptive analyses, and frequency&#xD;
      data collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>
    <intervention_model_description>Within subjects repeated measures</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability and feasibility</measure>
    <time_frame>5 weeks</time_frame>
    <description>Survey measure of acceptability and feasibility of the novel study in a health care setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in acceptability and feasibility from 5 weeks</measure>
    <time_frame>13 weeks</time_frame>
    <description>Survey measure of a change in acceptability and feasibility of the novel study in a health care setting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Personal Medical History Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of relevant medical history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Specific Self Efficacy Scales</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of one's belief that one can engage in health behavior and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health specific self efficacy from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of one's belief that one can engage in health behavior and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health specific self efficacy from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of one's belief that one can engage in health behavior and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Beliefs and Benefits Scale (EBBS)</measure>
    <time_frame>Baseline, 5-, and 13-weeks</time_frame>
    <description>Measure of one's belief that one can engage in exercise and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise Beliefs and Benefits Scale (EBBS) from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of one's belief that one can engage in exercise and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of one's belief that one can engage in exercise and it is important</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 8 (SF-8)</measure>
    <time_frame>Baseline, 5-, and 13-weeks</time_frame>
    <description>Measure of subjective health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-8 from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of subjective health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-8 from 5 weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of subjective health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire (IPAQ)</measure>
    <time_frame>Baseline, 5-, and 13-weeks</time_frame>
    <description>Measure of weekly physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Physical Activity Questionnaire (IPAQ) from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of weekly physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of weekly physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Food Frequency Questionnaire (S-FFQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of food consumption across different food groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of food consumption across different food groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of food consumption across different food groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale (SWL)</measure>
    <time_frame>Baseline, 5-, and 13-weeks</time_frame>
    <description>Measure of overall well being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Life Scale (SWL) from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of overall well being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction with Life Scale (SWL) from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of overall well being</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Group Attitude Scale</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of group cohesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Group Attitude Scale from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of group cohesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of self reported high</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of self reported weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of self reported weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of self reported weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average daily steps</measure>
    <time_frame>Baseline</time_frame>
    <description>Measure of self reported average daily steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average daily steps from baseline</measure>
    <time_frame>5-weeks</time_frame>
    <description>Measure of self reported average daily steps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average daily steps from 5-weeks</measure>
    <time_frame>13-weeks</time_frame>
    <description>Measure of self reported average daily steps</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Group Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive behavioral experiential group therapy for health behavior change</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral experiential group therapy</intervention_name>
    <description>The Kickstart Health Program is a Cognitive-Behavioral Experiential Therapy (CBET) that is administered via a person-centered group therapy format. Participants receive multiple therapeutic components that include psychoeducation, cognitive behavioral therapy, motivational interviewing, mindfulness, and acceptance and commitment therapy. Participants will also meditate and exercise in the group.</description>
    <arm_group_label>Group Intervention</arm_group_label>
    <other_name>Kickstart Health</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient of the Beaumont Family Medicine Center - Troy/Sterling Heights&#xD;
&#xD;
          -  Access to a computer or electronic device with an internet browser&#xD;
&#xD;
          -  Internet connectivity&#xD;
&#xD;
          -  Patient verbally confirms during recruitment phone call that they can independently or&#xD;
             with minimal assistance complete online surveys&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not have regular access to internet connectivity&#xD;
&#xD;
          -  Not approved by their physician to complete the group exercises&#xD;
&#xD;
          -  Denies the ability to fill out online surveys with minimal assistance&#xD;
&#xD;
          -  Non-English speaking&#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>
  <overall_official>
    <last_name>Lori Lackman-Zeman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Family Medicine</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>September 25, 2018</last_update_submitted>
  <last_update_submitted_qc>September 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Lackman-Zeman, Lori A, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Integrated Behavioral Health Care</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03308162
org study id: 2017-270
nct id: NCT03308162
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is testing the acceptability and feasibility of an active, experiential group
      therapy for health behavior change within a medical setting.
The purpose of the current study is to offer a preliminary test of feasibility and
      acceptability for a group intervention, conducted in a primary care setting, that aims to
      teach skills that initiate health behavior change. Participants will be recruited from a
      local family medicine clinic and groups will be held on site at the clinic. Patients will be
      recruited by their physicians and given a baseline survey of their exercise and nutrition
      behaviors as well as their overall well being and self efficacy to change their health
      behaviors. Participants can join the group at any time and attend as many sessions as
      desired. Groups are held 2 times per month and include worksheets, meditations, and exercise.
      Patients and their providers will be given 2 follow up surveys after 5 and 13 weeks to assess
      for acceptability and feasibility of the program, as well as health behavior change.
      Statistical analyses will include multivariate analyses, descriptive analyses, and frequency
      data collection.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Within subjects repeated measures
primary purpose: Treatment
masking: None (Open Label)
measure: Acceptability and feasibility
time frame: 5 weeks
description: Survey measure of acceptability and feasibility of the novel study in a health care setting
measure: Change in acceptability and feasibility from 5 weeks
time frame: 13 weeks
description: Survey measure of a change in acceptability and feasibility of the novel study in a health care setting
measure: Personal Medical History Questionnaire
time frame: Baseline
description: Measure of relevant medical history
measure: Health Specific Self Efficacy Scales
time frame: Baseline
description: Measure of one's belief that one can engage in health behavior and it is important
measure: Change in health specific self efficacy from baseline
time frame: 5-weeks
description: Measure of one's belief that one can engage in health behavior and it is important
measure: Change in health specific self efficacy from 5-weeks
time frame: 13-weeks
description: Measure of one's belief that one can engage in health behavior and it is important
measure: Exercise Beliefs and Benefits Scale (EBBS)
time frame: Baseline, 5-, and 13-weeks
description: Measure of one's belief that one can engage in exercise and it is important
measure: Change in exercise Beliefs and Benefits Scale (EBBS) from baseline
time frame: 5-weeks
description: Measure of one's belief that one can engage in exercise and it is important
measure: Change in exercise Beliefs and Benefits Scale (EBBS) from 5-weeks
time frame: 13-weeks
description: Measure of one's belief that one can engage in exercise and it is important
measure: Short Form 8 (SF-8)
time frame: Baseline, 5-, and 13-weeks
description: Measure of subjective health
measure: Change in SF-8 from baseline
time frame: 5-weeks
description: Measure of subjective health
measure: Change in SF-8 from 5 weeks
time frame: 13-weeks
description: Measure of subjective health
measure: International Physical Activity Questionnaire (IPAQ)
time frame: Baseline, 5-, and 13-weeks
description: Measure of weekly physical activity
measure: Change in International Physical Activity Questionnaire (IPAQ) from baseline
time frame: 5-weeks
description: Measure of weekly physical activity
measure: Change in International Physical Activity Questionnaire (IPAQ) from 5-weeks
time frame: 13-weeks
description: Measure of weekly physical activity
measure: Simple Food Frequency Questionnaire (S-FFQ)
time frame: Baseline
description: Measure of food consumption across different food groups
measure: Change in Simple Food Frequency Questionnaire (S-FFQ) from baseline
time frame: 5-weeks
description: Measure of food consumption across different food groups
measure: Change in Simple Food Frequency Questionnaire (S-FFQ) from 5-weeks
time frame: 13-weeks
description: Measure of food consumption across different food groups
measure: Satisfaction with Life Scale (SWL)
time frame: Baseline, 5-, and 13-weeks
description: Measure of overall well being
measure: Change in Satisfaction with Life Scale (SWL) from baseline
time frame: 5-weeks
description: Measure of overall well being
measure: Change in Satisfaction with Life Scale (SWL) from 5-weeks
time frame: 13-weeks
description: Measure of overall well being
measure: The Group Attitude Scale
time frame: 5-weeks
description: Measure of group cohesion
measure: Change in The Group Attitude Scale from 5-weeks
time frame: 13-weeks
description: Measure of group cohesion
measure: Height
time frame: Baseline
description: Measure of self reported high
measure: Weight
time frame: Baseline
description: Measure of self reported weight
measure: Change in weight from baseline
time frame: 5-weeks
description: Measure of self reported weight
measure: Change in weight from 5-weeks
time frame: 13-weeks
description: Measure of self reported weight
measure: Average daily steps
time frame: Baseline
description: Measure of self reported average daily steps
measure: Change in average daily steps from baseline
time frame: 5-weeks
description: Measure of self reported average daily steps
measure: Change in average daily steps from 5-weeks
time frame: 13-weeks
description: Measure of self reported average daily steps
arm group label: Group Intervention
arm group type: Experimental
description: Cognitive behavioral experiential group therapy for health behavior change
intervention type: Behavioral
intervention name: Cognitive behavioral experiential group therapy
description: The Kickstart Health Program is a Cognitive-Behavioral Experiential Therapy (CBET) that is administered via a person-centered group therapy format. Participants receive multiple therapeutic components that include psychoeducation, cognitive behavioral therapy, motivational interviewing, mindfulness, and acceptance and commitment therapy. Participants will also meditate and exercise in the group.
arm group label: Group Intervention
other name: Kickstart Health
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lori Lackman-Zeman, PhD
role: Principal Investigator
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Lackman-Zeman, Lori A, PhD
investigator title: Principal Investigator
sharing ipd: No