<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/NCT03272438</url>
  </required_header>
  <id_info>
    <org_study_id>BrandeisU</org_study_id>
    <nct_id>NCT03272438</nct_id>
  </id_info>
  <brief_title>Schedule Intervention to Increase Sustainable Walking Activity in Midlife Working Adults</brief_title>
  <official_title>Using a Schedule Intervention to Increase Sustainable Walking Activity in Midlife</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brandeis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brandeis University</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>
      While people commonly understand that regular physical exercise conveys many health benefits,&#xD;
      only 20% of U.S. adults take regular exercise and they have difficulty maintaining new&#xD;
      healthy behaviors. The goal of this study is to use a planning intervention to help establish&#xD;
      and maintain a daily step regimen in working midlife adults. The investigators will ask&#xD;
      participants to plan when, where, and how to act on a daily walking goal in conjunction with&#xD;
      a scheduling intervention to increase the chances that they will maintain this new regimen.&#xD;
      The effectiveness of three different scheduling interventions will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While people commonly understand that regular physical exercise conveys many health benefits,&#xD;
      only 20% of U.S. adults take regular exercise and they have difficulty maintaining new&#xD;
      healthy behaviors. The goal of this study is to use a planning intervention to help establish&#xD;
      and maintain a daily step regimen in working midlife adults. The investigators will ask&#xD;
      participants to plan when, where, and how to act on a daily walking goal in conjunction with&#xD;
      a scheduling intervention to increase the chances that they will maintain this new regimen.&#xD;
      Participants will be randomly assigned to one of three conditions: consistent schedule,&#xD;
      inconsistent schedule, no schedule. All participants will be provided with an accelerometer&#xD;
      to measure their daily activity and as a behavioral support for our intervention and they&#xD;
      will be given a step goal. The goal given to each individual will be to increase immediately&#xD;
      their daily steps to a level based on recommended guidelines (e.g., Hill, Wyatt, Reed, and&#xD;
      Peters, 2003). The investigators will test which version of the scheduling intervention is&#xD;
      most successful for increasing and maintaining step counts. It is predicted that participants&#xD;
      in the consistent schedule condition will increase their step count more than those&#xD;
      participants in the no schedule control condition, and that they will maintain this activity&#xD;
      for a longer period after the intervention period is complete than those participants in the&#xD;
      inconsistent schedule condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Participants will be randomly assigned to one of three between-subjects conditions: consistent schedule, inconsistent schedule, no schedule. The study is a longitudinal study over 9 weeks, including a baseline week, a 4-week intervention and a follow-up assessment 4 weeks after the intervention.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants are not aware of whether they are in an experimental or control condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Daily for 9 weeks</time_frame>
    <description>Number of steps taken each day as measured on accelerometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measures of well being</measure>
    <time_frame>Before and after intervention (5 weeks apart), and at followup (4 weeks later)</time_frame>
    <description>Feelings of satisfaction with life, perceived stress, mood and sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity self-efficacy and ease</measure>
    <time_frame>Weekly for 4 weeks</time_frame>
    <description>Perceived ability and ease of being physically active</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>No schedule control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will also monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Consistent schedule condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in consistent contexts, i.e., that are very similar from day to day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inconsistent schedule condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in inconsistent contexts, i.e., that vary from day to day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Accelerometer</intervention_name>
    <description>Participants use an accelerometer to monitor their steps activity</description>
    <arm_group_label>Consistent schedule condition</arm_group_label>
    <arm_group_label>Inconsistent schedule condition</arm_group_label>
    <arm_group_label>No schedule control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Step goal</intervention_name>
    <description>Participants are given a daily step goal to aim for</description>
    <arm_group_label>Consistent schedule condition</arm_group_label>
    <arm_group_label>Inconsistent schedule condition</arm_group_label>
    <arm_group_label>No schedule control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Consistent contexts</intervention_name>
    <description>Participants plan to take steps in contexts that are similar from day to day</description>
    <arm_group_label>Consistent schedule condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inconsistent contexts</intervention_name>
    <description>Participants plan to take steps in contexts that vary from day to day</description>
    <arm_group_label>Inconsistent schedule condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  currently working 3 or more days (or 24 hours or more) per week;&#xD;
&#xD;
          -  physically minimally active (as determined using the International Physical Activity&#xD;
             Questionnaire (IPAQ)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a recent (within the past 6 months) cardiovascular event, or fall.&#xD;
&#xD;
          -  anyone who already exercises regularly, 3 times a week or more for at least 30&#xD;
             minutes, will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Ebert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brandeis University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jane Ebert, PhD</last_name>
    <phone>7817362294</phone>
    <email>jebert@brandeis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Margie Lachman, PhD</last_name>
    <phone>781-736-3255</phone>
    <email>lachman@brandeis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Brandeis University</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02453-2728</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jane Elizabeth J Ebert, PhD</last_name>
      <phone>781-736-2294</phone>
      <email>jebert@brandeis.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.</citation>
    <PMID>12574618</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>April 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brandeis University</investigator_affiliation>
    <investigator_full_name>Jane Ebert</investigator_full_name>
    <investigator_title>Associate Professor of Marketing</investigator_title>
  </responsible_party>
  <keyword>steps</keyword>
  <keyword>goals</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/NCT03272438
org study id: BrandeisU
nct id: NCT03272438
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
While people commonly understand that regular physical exercise conveys many health benefits,
      only 20% of U.S. adults take regular exercise and they have difficulty maintaining new
      healthy behaviors. The goal of this study is to use a planning intervention to help establish
      and maintain a daily step regimen in working midlife adults. The investigators will ask
      participants to plan when, where, and how to act on a daily walking goal in conjunction with
      a scheduling intervention to increase the chances that they will maintain this new regimen.
      The effectiveness of three different scheduling interventions will be compared.
While people commonly understand that regular physical exercise conveys many health benefits,
      only 20% of U.S. adults take regular exercise and they have difficulty maintaining new
      healthy behaviors. The goal of this study is to use a planning intervention to help establish
      and maintain a daily step regimen in working midlife adults. The investigators will ask
      participants to plan when, where, and how to act on a daily walking goal in conjunction with
      a scheduling intervention to increase the chances that they will maintain this new regimen.
      Participants will be randomly assigned to one of three conditions: consistent schedule,
      inconsistent schedule, no schedule. All participants will be provided with an accelerometer
      to measure their daily activity and as a behavioral support for our intervention and they
      will be given a step goal. The goal given to each individual will be to increase immediately
      their daily steps to a level based on recommended guidelines (e.g., Hill, Wyatt, Reed, and
      Peters, 2003). The investigators will test which version of the scheduling intervention is
      most successful for increasing and maintaining step counts. It is predicted that participants
      in the consistent schedule condition will increase their step count more than those
      participants in the no schedule control condition, and that they will maintain this activity
      for a longer period after the intervention period is complete than those participants in the
      inconsistent schedule condition.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of three between-subjects conditions: consistent schedule, inconsistent schedule, no schedule. The study is a longitudinal study over 9 weeks, including a baseline week, a 4-week intervention and a follow-up assessment 4 weeks after the intervention.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants are not aware of whether they are in an experimental or control condition.
measure: Physical activity
time frame: Daily for 9 weeks
description: Number of steps taken each day as measured on accelerometer
measure: Measures of well being
time frame: Before and after intervention (5 weeks apart), and at followup (4 weeks later)
description: Feelings of satisfaction with life, perceived stress, mood and sleep quality
measure: Physical activity self-efficacy and ease
time frame: Weekly for 4 weeks
description: Perceived ability and ease of being physically active
arm group label: No schedule control
arm group type: Active Comparator
description: This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will also monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions.
arm group label: Consistent schedule condition
arm group type: Experimental
description: This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in consistent contexts, i.e., that are very similar from day to day.
arm group label: Inconsistent schedule condition
arm group type: Active Comparator
description: This group will receive an accelerometer and daily step goal. They will monitor their steps over the 9 week duration of the study. They will have the same level of contact as the other two conditions. In addition they will plan when, where, and how they will take steps in inconsistent contexts, i.e., that vary from day to day.
intervention type: Device
intervention name: Accelerometer
description: Participants use an accelerometer to monitor their steps activity
arm group label: Consistent schedule condition
arm group label: Inconsistent schedule condition
arm group label: No schedule control
intervention type: Behavioral
intervention name: Step goal
description: Participants are given a daily step goal to aim for
arm group label: Consistent schedule condition
arm group label: Inconsistent schedule condition
arm group label: No schedule control
intervention type: Behavioral
intervention name: Consistent contexts
description: Participants plan to take steps in contexts that are similar from day to day
arm group label: Consistent schedule condition
intervention type: Behavioral
intervention name: Inconsistent contexts
description: Participants plan to take steps in contexts that vary from day to day
arm group label: Inconsistent schedule condition
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Ebert, PhD
role: Principal Investigator
affiliation: Brandeis University
last name: Jane Ebert, PhD
phone: 7817362294
email: jebert@brandeis.edu
last name: Margie Lachman, PhD
phone: 781-736-3255
email: lachman@brandeis.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: Hill JO, Wyatt HR, Reed GW, Peters JC. Obesity and the environment: where do we go from here? Science. 2003 Feb 7;299(5608):853-5. doi: 10.1126/science.1079857.
PMID: 12574618
responsible party type: Principal Investigator
investigator affiliation: Brandeis University
investigator full name: Jane Ebert
investigator title: Associate Professor of Marketing
sharing ipd: No