xml: <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/NCT06024577</url>
    </required_header>
    <id_info>
      <org_study_id>2023-152</org_study_id>
      <nct_id>NCT06024577</nct_id>
    </id_info>
    <brief_title>Adherence to Different Exercise Interventions</brief_title>
    <official_title>Aherence to Different Exercise Interventions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>California Polytechnic State University-San Luis Obispo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>California Polytechnic State University-San Luis Obispo</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Only 50% of sedentary adults that start an exercise training program adhere to the program&#xD;
        after 6 months. Exercise variety may improve adherence. The goal of this study is to examine&#xD;
        different exercise interventions that include a variety of exercise on adherence.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Regular exercise, in the form of walking 150 minutes per week, is widely regarded as having&#xD;
        many health and fitness benefits. Despite these well-known benefits, adherence to exercise&#xD;
        interventions is extremely low. When sedentary adults start an exercise training program only&#xD;
        50% adhere to the program and meet the national recommendations of 150 minutes per week. A&#xD;
        possible explanation of the low adherence is that most adults only walk for exercise, and&#xD;
        that providing a variety of exercise may increase adherence. Preliminary observational data&#xD;
        show that a variety of exercise may increase weekly exercise expenditure compared to other&#xD;
        interventions. The overall objective of this study is to investigate the feasibility,&#xD;
        adherence, and acceptability of different exercise interventions including 1) walk&#xD;
        intervention, 2) variety intervention, and 3) progressive intervention (see below for&#xD;
        description).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">July 2028</completion_date>
    <primary_completion_date type="Anticipated">July 2027</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized study to three arms: 1) walk intervention, 2) variety intervention, 3) progressive intervention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Research staff collecting data will be masked to intervention</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Adherence to exercise intervention</measure>
      <time_frame>Change from baseline at 1-week, 2-weeks, 3-weeks, and 4-weeks</time_frame>
      <description>Adherence is assessed as meeting or exceeding 150 minutes per week of moderate to vigorous exercise</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of intervention</measure>
      <time_frame>Acceptability at 4-weeks</time_frame>
      <description>Participants will complete a survey on acceptability at the end of the exercise intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Weight</measure>
      <time_frame>Change in body weight from baseline to 4-weeks</time_frame>
      <description>Body weight will be measured at baseline and 4-weeks</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Exercise Adherence</condition>
    <arm_group>
      <arm_group_label>Walking</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants prescribed 150 minutes/week of moderate to vigorous walking.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Variety</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants prescribed 150 minutes/week of moderate to vigorous variety of exercise. Each week participants will be prescribed a single different exercise (variety) which will include cycling, walking/jogging, yoga/Pilates, and cross-training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Progressive</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants prescribed 150 minutes/week of moderate to vigorous exercise. The exercises include cycling, walking/jogging, yoga/Pilates, and cross-training, and each week another exercise will be added to the list of options for participants. Participants may choose from the list of exercise. They do not have to do them all, and they can do as much or little (none) of whatever they choose.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Walking</intervention_name>
      <description>Prescribed 150 minutes per week of moderate to vigorous walking.</description>
      <arm_group_label>Walking</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Variety</intervention_name>
      <description>Prescribed 150 minutes per week of moderate to vigorous variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training.</description>
      <arm_group_label>Variety</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Progressive</intervention_name>
      <description>Prescribed 150 minutes per week of moderate to vigorous progressive variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training. Participants can choose which exercise they want to do, and can do as much or little as they want.</description>
      <arm_group_label>Progressive</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-40 years old&#xD;
  &#xD;
            -  Sedentary (&lt;1 hour per week of exercise)&#xD;
  &#xD;
            -  BMI 18.5 to 40 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Adults with diagnosed cardiovascular, diabetes, renal, or any other metabolic disease&#xD;
               determined by Health and Fitness History questionnaire.&#xD;
  &#xD;
            -  Any other disability, ailment, or physical characteristics that may hinder the ability&#xD;
               to participate in regular exercise determined by Health and Fitness History&#xD;
               questionnaire.&#xD;
  &#xD;
            -  Participating in other studies that would interfere with their ability to safely&#xD;
               complete the exercise protocols.&#xD;
  &#xD;
            -  Pregnant or trying to become pregnant, and peri-menopausal or post-menopausal women.&#xD;
  &#xD;
            -  History of smoking within the last 6 months&#xD;
  &#xD;
            -  Any other vulnerable population (children &lt;18, pregnant women, prisoners, etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Gender criteria are:&#xD;
  Cisgender man (non transgender)&#xD;
  Cisgender woman (non transgender)&#xD;
  Transgender man&#xD;
  Transgender woman</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Todd Hagobian</last_name>
      <role>Principal Investigator</role>
      <affiliation>California Polytechnic State University-San Luis Obispo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Todd Hagobian, PhD</last_name>
      <phone>8057567511</phone>
      <email>thagobia@calpoly.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Adam Seal, PhD</last_name>
      <phone>8057562545</phone>
      <email>adseal@calpoly.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>California Polytechnic State University</name>
        <address>
          <city>San Luis Obispo</city>
          <state>California</state>
          <zip>93407</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eric Benson</last_name>
        <phone>805-756-7525</phone>
        <email>ecbenson@calpoly.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>California Polytechnic State University-San Luis Obispo</investigator_affiliation>
      <investigator_full_name>Todd Hagobian</investigator_full_name>
      <investigator_title>Chair and Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Seven years after the date of the last participant completing the study.</ipd_time_frame>
      <ipd_access_criteria>Contact PI and a date-sharing agreement will be created that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology (password protected and encrypted); (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually.</ipd_access_criteria>
      <ipd_url>http://healthresearch.calpoly.edu/</ipd_url>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 29, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT06024577/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 29, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT06024577/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024577
  org study id: 2023-152
  nct id: NCT06024577
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Only 50% of sedentary adults that start an exercise training program adhere to the program
        after 6 months. Exercise variety may improve adherence. The goal of this study is to examine
        different exercise interventions that include a variety of exercise on adherence.
  Regular exercise, in the form of walking 150 minutes per week, is widely regarded as having
        many health and fitness benefits. Despite these well-known benefits, adherence to exercise
        interventions is extremely low. When sedentary adults start an exercise training program only
        50% adhere to the program and meet the national recommendations of 150 minutes per week. A
        possible explanation of the low adherence is that most adults only walk for exercise, and
        that providing a variety of exercise may increase adherence. Preliminary observational data
        show that a variety of exercise may increase weekly exercise expenditure compared to other
        interventions. The overall objective of this study is to investigate the feasibility,
        adherence, and acceptability of different exercise interventions including 1) walk
        intervention, 2) variety intervention, and 3) progressive intervention (see below for
        description).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized study to three arms: 1) walk intervention, 2) variety intervention, 3) progressive intervention
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Research staff collecting data will be masked to intervention
  measure: Adherence to exercise intervention
  time frame: Change from baseline at 1-week, 2-weeks, 3-weeks, and 4-weeks
  description: Adherence is assessed as meeting or exceeding 150 minutes per week of moderate to vigorous exercise
  measure: Acceptability of intervention
  time frame: Acceptability at 4-weeks
  description: Participants will complete a survey on acceptability at the end of the exercise intervention
  measure: Body Weight
  time frame: Change in body weight from baseline to 4-weeks
  description: Body weight will be measured at baseline and 4-weeks
  arm group label: Walking
  arm group type: Active Comparator
  description: Participants prescribed 150 minutes/week of moderate to vigorous walking.
  arm group label: Variety
  arm group type: Experimental
  description: Participants prescribed 150 minutes/week of moderate to vigorous variety of exercise. Each week participants will be prescribed a single different exercise (variety) which will include cycling, walking/jogging, yoga/Pilates, and cross-training.
  arm group label: Progressive
  arm group type: Experimental
  description: Participants prescribed 150 minutes/week of moderate to vigorous exercise. The exercises include cycling, walking/jogging, yoga/Pilates, and cross-training, and each week another exercise will be added to the list of options for participants. Participants may choose from the list of exercise. They do not have to do them all, and they can do as much or little (none) of whatever they choose.
  intervention type: Behavioral
  intervention name: Walking
  description: Prescribed 150 minutes per week of moderate to vigorous walking.
  arm group label: Walking
  intervention type: Behavioral
  intervention name: Variety
  description: Prescribed 150 minutes per week of moderate to vigorous variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training.
  arm group label: Variety
  intervention type: Behavioral
  intervention name: Progressive
  description: Prescribed 150 minutes per week of moderate to vigorous progressive variety of exercise. Each week participants are randomly asked to participate in cycling, walking/jogging, yoga/Pilates, or cross-training. Participants can choose which exercise they want to do, and can do as much or little as they want.
  arm group label: Progressive
  criteria: 
  gender: All
  gender based: Yes
  gender description: Gender criteria are:
  Cisgender man (non transgender)
  Cisgender woman (non transgender)
  Transgender man
  Transgender woman
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Todd Hagobian
  role: Principal Investigator
  affiliation: California Polytechnic State University-San Luis Obispo
  last name: Todd Hagobian, PhD
  phone: 8057567511
  email: thagobia@calpoly.edu
  last name: Adam Seal, PhD
  phone: 8057562545
  email: adseal@calpoly.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: California Polytechnic State University-San Luis Obispo
  investigator full name: Todd Hagobian
  investigator title: Chair and Professor
  sharing ipd: Yes
  ipd description: Data and documentation will be available under a data-sharing agreement. Information shared with outside collaborators will link data to two unique study identifiers (de-Identified) to maintain participant anonymity, and outside researchers and the community will not be allowed to have access to participant names and confidential information.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Seven years after the date of the last participant completing the study.
  ipd access criteria: Contact PI and a date-sharing agreement will be created that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology (password protected and encrypted); (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually.
  ipd url: http://healthresearch.calpoly.edu/
  provided document: 
  provided document: 