<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/NCT02990039</url>
  </required_header>
  <id_info>
    <org_study_id>FKZ 81Z5400152</org_study_id>
    <nct_id>NCT02990039</nct_id>
  </id_info>
  <brief_title>A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time</brief_title>
  <official_title>A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medicine Greifswald</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was (i) to develop a brief counseling letter intervention aiming to&#xD;
      reduce sedentary time and to increase physical activity during leisure time among adults aged&#xD;
      42 to 64 years and (ii) to provide information on the feasibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aimed to assess the feasibility of a brief counseling letter intervention to&#xD;
      increase physical activity and to reduce sedentary time in leisure time.&#xD;
&#xD;
      Following the Intervention Mapping Protocol we developed the counseling letter intervention.&#xD;
      The intervention is based on the Health Action Process Approach, comprising 3 tailored&#xD;
      letters based on separate assessments, delivered over 6 month.&#xD;
&#xD;
      All participants consented (i) to participate in an examination at the university hospital&#xD;
      including standardized measurements of blood pressure, waist and hip circumference, body&#xD;
      height and weight as well as blood sample taking, (ii) to fill in a paper-pencil&#xD;
      questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month&#xD;
      follow-up.&#xD;
&#xD;
      A general population sample of cardiovascular healthy adults was randomly allocated to a&#xD;
      control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and&#xD;
      12-month follow-up) participants of both study groups completed standardized questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence: Drop-out rates in control and intervention group</measure>
    <time_frame>up to 12 month</time_frame>
    <description>Measures: Analyses of drop-out rates (%) in control and intervention group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility: Comprehensibility on intervention material via paper-pencil-assessment</measure>
    <time_frame>12 month</time_frame>
    <description>Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity by self-report</measure>
    <time_frame>Change from Baseline Physical Activity at 12 months</time_frame>
    <description>Measures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity by accelerometry</measure>
    <time_frame>Change from Baseline Physical Activity at 12 months</time_frame>
    <description>Measures: objective measurement of physical activity by accelerometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sedentary time by self-report</measure>
    <time_frame>Change from Baseline Sedentary Time at 12 months</time_frame>
    <description>Measures: paper-pencil-assessment (last 7-d sedentary behavior questionnaire, SIT-Q-7d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sedentary time by accelerometry</measure>
    <time_frame>Change from Baseline Sedentary Time at 12 months</time_frame>
    <description>Measures: objective measurement of physical activity by accelerometry</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Counseling letter (intervention group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants of the intervention group received a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity. The intervention comprised up to three tailored letters based on separate questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No counseling letter (control group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants of the control group did not received the brief counseling letter intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling letter</intervention_name>
    <description>The intervention is based on the Health Action Process Approach. The first letter provides information on knowledge regarding sedentary time and physical activity as well as intervenes on self-efficacy depending on the mindset of participants (non-intender, intender, actor). The second letter focuses on benefits and barriers of physical activity as well as the role of social support for physical activity. In case of actional stage, the third letter intervenes on self-efficacy again and suggests action and coping planning. Otherwise, the letter includes ipsative feedback according to the second letter.</description>
    <arm_group_label>Counseling letter (intervention group)</arm_group_label>
    <other_name>Feasibility of brief counseling letter intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 42 and 65 years&#xD;
&#xD;
          -  resident in a pre-defined zip-code area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cardiovascular event (myocardial infarction, stroke) or vascular intervention&#xD;
&#xD;
          -  self-reported body-mass-index over 35 kg/m²&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabina Ulbricht, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany</affiliation>
  </overall_official>
  <results_reference>
    <citation>Voigt L, Baumann S, Ullrich A, Weymar F, John U, Ulbricht S. The effect of mere measurement from a cardiovascular examination program on physical activity and sedentary time in an adult population. BMC Sports Sci Med Rehabil. 2018 Jan 23;10:1. doi: 10.1186/s13102-018-0090-8. eCollection 2018.</citation>
    <PMID>29410786</PMID>
  </results_reference>
  <results_reference>
    <citation>Ullrich A, Voigt L, Baumann S, Weymar F, John U, Dorr M, Ulbricht S. A cross-sectional analysis of the associations between leisure-time sedentary behaviors and clustered cardiometabolic risk. BMC Public Health. 2018 Mar 6;18(1):327. doi: 10.1186/s12889-018-5213-3.</citation>
    <PMID>29510707</PMID>
  </results_reference>
  <results_reference>
    <citation>Baumann S, Gross S, Voigt L, Ullrich A, Weymar F, Schwaneberg T, Dorr M, Meyer C, John U, Ulbricht S. Pitfalls in accelerometer-based measurement of physical activity: The presence of reactivity in an adult population. Scand J Med Sci Sports. 2018 Mar;28(3):1056-1063. doi: 10.1111/sms.12977. Epub 2017 Oct 12.</citation>
    <PMID>28921747</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>sedentary time</keyword>
  <keyword>feasibility study</keyword>
  <keyword>accelerometer</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/NCT02990039
org study id: FKZ 81Z5400152
nct id: NCT02990039
lead sponsor: 
has dmc: No
The purpose of this study was (i) to develop a brief counseling letter intervention aiming to
      reduce sedentary time and to increase physical activity during leisure time among adults aged
      42 to 64 years and (ii) to provide information on the feasibility.
The study aimed to assess the feasibility of a brief counseling letter intervention to
      increase physical activity and to reduce sedentary time in leisure time.

      Following the Intervention Mapping Protocol we developed the counseling letter intervention.
      The intervention is based on the Health Action Process Approach, comprising 3 tailored
      letters based on separate assessments, delivered over 6 month.

      All participants consented (i) to participate in an examination at the university hospital
      including standardized measurements of blood pressure, waist and hip circumference, body
      height and weight as well as blood sample taking, (ii) to fill in a paper-pencil
      questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month
      follow-up.

      A general population sample of cardiovascular healthy adults was randomly allocated to a
      control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and
      12-month follow-up) participants of both study groups completed standardized questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Adherence: Drop-out rates in control and intervention group
time frame: up to 12 month
description: Measures: Analyses of drop-out rates (%) in control and intervention group
measure: Feasibility: Comprehensibility on intervention material via paper-pencil-assessment
time frame: 12 month
description: Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)
measure: physical activity by self-report
time frame: Change from Baseline Physical Activity at 12 months
description: Measures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L)
measure: physical activity by accelerometry
time frame: Change from Baseline Physical Activity at 12 months
description: Measures: objective measurement of physical activity by accelerometry
measure: sedentary time by self-report
time frame: Change from Baseline Sedentary Time at 12 months
description: Measures: paper-pencil-assessment (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
measure: sedentary time by accelerometry
time frame: Change from Baseline Sedentary Time at 12 months
description: Measures: objective measurement of physical activity by accelerometry
arm group label: Counseling letter (intervention group)
arm group type: Experimental
description: Participants of the intervention group received a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity. The intervention comprised up to three tailored letters based on separate questionnaires.
arm group label: No counseling letter (control group)
arm group type: No Intervention
description: Participants of the control group did not received the brief counseling letter intervention.
intervention type: Behavioral
intervention name: Counseling letter
description: The intervention is based on the Health Action Process Approach. The first letter provides information on knowledge regarding sedentary time and physical activity as well as intervenes on self-efficacy depending on the mindset of participants (non-intender, intender, actor). The second letter focuses on benefits and barriers of physical activity as well as the role of social support for physical activity. In case of actional stage, the third letter intervenes on self-efficacy again and suggests action and coping planning. Otherwise, the letter includes ipsative feedback according to the second letter.
arm group label: Counseling letter (intervention group)
other name: Feasibility of brief counseling letter intervention
criteria: 
gender: All
minimum age: 42 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sabina Ulbricht, Dr.
role: Study Chair
affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
citation: Voigt L, Baumann S, Ullrich A, Weymar F, John U, Ulbricht S. The effect of mere measurement from a cardiovascular examination program on physical activity and sedentary time in an adult population. BMC Sports Sci Med Rehabil. 2018 Jan 23;10:1. doi: 10.1186/s13102-018-0090-8. eCollection 2018.
PMID: 29410786
citation: Ullrich A, Voigt L, Baumann S, Weymar F, John U, Dorr M, Ulbricht S. A cross-sectional analysis of the associations between leisure-time sedentary behaviors and clustered cardiometabolic risk. BMC Public Health. 2018 Mar 6;18(1):327. doi: 10.1186/s12889-018-5213-3.
PMID: 29510707
citation: Baumann S, Gross S, Voigt L, Ullrich A, Weymar F, Schwaneberg T, Dorr M, Meyer C, John U, Ulbricht S. Pitfalls in accelerometer-based measurement of physical activity: The presence of reactivity in an adult population. Scand J Med Sci Sports. 2018 Mar;28(3):1056-1063. doi: 10.1111/sms.12977. Epub 2017 Oct 12.
PMID: 28921747
responsible party type: Sponsor
sharing ipd: Undecided