<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/NCT04457128</url>
  </required_header>
  <id_info>
    <org_study_id>20-03-3472</org_study_id>
    <nct_id>NCT04457128</nct_id>
  </id_info>
  <brief_title>Real-time Behavioral Interventions</brief_title>
  <official_title>Just-in-Time Adaptive Intervention to Reduce Sedentary Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama, Tuscaloosa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama, Tuscaloosa</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>
      The goal of this study is to adapt an evidence-based sedentary behavior reduction&#xD;
      intervention for men and women living in Alabama and determine its feasibility, acceptance,&#xD;
      and limited efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to adapt an evidence-based sedentary behavior reduction&#xD;
      intervention for men and women living in Alabama and determine its feasibility, acceptance,&#xD;
      and limited efficacy. Community-based Participatory Research methods will be used to adapt an&#xD;
      evidence-based curriculum. The adapted curriculum will be delivered via print-based materials&#xD;
      and a mobile phone app developed by an external collaborator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Micro-randomized trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usage</measure>
    <time_frame>16 weeks</time_frame>
    <description>To percentage of time participants were complying with the study protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Usage, Satisfaction, Ease of use Questionnaire</measure>
    <time_frame>16 weeks</time_frame>
    <description>Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in sedentary time</measure>
    <time_frame>Week 0 and Week 16</time_frame>
    <description>Accelerometer determined breaks in inactivity during waking hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in light-intensity physical activity</measure>
    <time_frame>Week 0 and Week 16</time_frame>
    <description>Accelerometer determined activity</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cancer</condition>
  <condition>Aging</condition>
  <condition>Comorbidities and Coexisting Conditions</condition>
  <arm_group>
    <arm_group_label>Secular Image</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Secular Image</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-secular image</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non-secular images</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secular message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>secular messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-secular message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non-secular messages</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Just-in-Time Adaptive Intervention</intervention_name>
    <description>Randomized factorial design</description>
    <arm_group_label>Non-secular image</arm_group_label>
    <arm_group_label>Non-secular message</arm_group_label>
    <arm_group_label>Secular Image</arm_group_label>
    <arm_group_label>Secular message</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • 50 to 75 years old at study enrollment;&#xD;
&#xD;
               -  Currently living in Alabama;&#xD;
&#xD;
               -  Community-dwelling (i.e., not living in an assisted living facility or nursing&#xD;
                  home);&#xD;
&#xD;
               -  Having access to the internet and a smart phone;&#xD;
&#xD;
               -  Able to perform light-intensity physical activity (i.e., walking);&#xD;
&#xD;
               -  English speaking;&#xD;
&#xD;
               -  Willing to consent to study procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reporting more than 60 minutes of purposeful physical activity per week;&#xD;
&#xD;
          -  Have an unstable mental condition that prevention study activities. Determined by the&#xD;
             Physician Health questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raheem Paxton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raheem Paxton, PhD</last_name>
    <phone>205-348-6857</phone>
    <email>rpaxton@ua.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Monica Anderson-Herzog, PhD</last_name>
    <phone>205 348 1667</phone>
    <email>Anderson@cs.ua.edu</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>ecological momentary assessment</keyword>
  <keyword>health-related quality of life</keyword>
  <keyword>Just-in-time adaptive intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No at this time</ipd_description>
  </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/NCT04457128
org study id: 20-03-3472
nct id: NCT04457128
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to adapt an evidence-based sedentary behavior reduction
      intervention for men and women living in Alabama and determine its feasibility, acceptance,
      and limited efficacy.
The goal of this study is to adapt an evidence-based sedentary behavior reduction
      intervention for men and women living in Alabama and determine its feasibility, acceptance,
      and limited efficacy. Community-based Participatory Research methods will be used to adapt an
      evidence-based curriculum. The adapted curriculum will be delivered via print-based materials
      and a mobile phone app developed by an external collaborator.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Micro-randomized trial
primary purpose: Prevention
masking: None (Open Label)
measure: Usage
time frame: 16 weeks
description: To percentage of time participants were complying with the study protocol
measure: The Usage, Satisfaction, Ease of use Questionnaire
time frame: 16 weeks
description: Questionnaire that assesses usage, satisfaction, and ease of use of technology. Each subscale has a maximum score of 20, with higher scores indicating a better outcome.
measure: Change in sedentary time
time frame: Week 0 and Week 16
description: Accelerometer determined breaks in inactivity during waking hours
measure: Change in light-intensity physical activity
time frame: Week 0 and Week 16
description: Accelerometer determined activity
arm group label: Secular Image
arm group type: Experimental
description: Secular Image
arm group label: Non-secular image
arm group type: Experimental
description: non-secular images
arm group label: Secular message
arm group type: Experimental
description: secular messages
arm group label: Non-secular message
arm group type: Experimental
description: non-secular messages
intervention type: Behavioral
intervention name: Just-in-Time Adaptive Intervention
description: Randomized factorial design
arm group label: Non-secular image
arm group label: Non-secular message
arm group label: Secular Image
arm group label: Secular message
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Raheem Paxton, PhD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Raheem Paxton, PhD
phone: 205-348-6857
email: rpaxton@ua.edu
last name: Monica Anderson-Herzog, PhD
phone: 205 348 1667
email: Anderson@cs.ua.edu
responsible party type: Sponsor
sharing ipd: No
ipd description: No at this time